cumulative biopharm subject and author index...

BioPharm Index 1

Cumulative BioPharm Subject and Author Index 1987–1994

AUTHORS

Adams, Dan G. Sizing Clean–Steam Generators.November–December 1988, p. 36.

Adams, Dan G., and Agarwal, Deepak. Clean-in-PlaceSystem Design. June 1989, p. 48.

Adema, E.; Shnek, D.; Cahn, F.; and Sinskey, A.J. Useof Porous Microcarriers in Agitated Cultures.July–August 1990, p. 20.

Adner, Niklas, and Sofer, Gail. Biotechnology ProductValidation, Part 3: Chromatography CleaningValidation. April 1994, p. 44.

Agalloco, James. Computer System Validation:Change Control. May 1990, p. 38.

Agarwal, Deepak. See Adams, Dan G.Akers, James E. Biotechnology Product Validation,

Part 6: Isolator Technology Applications.July–August 1994, p. 43.

Akers, James; McEntire, John; and Sofer, Gail.Biotechnology Product Validation, Part 1:Identifying the Pitfalls. January 1994, p. 40.

Akers, James; McEntire, John; and Sofer, Gail.Biotechnology Product Validation, Part 2: ALogical Plan. March 1994, p. 54.

Alford, Bernadette L., and O’Donnell, Kathleen D.Establishment of a Quality Control Laboratory: TheRole of Product Testing of Protein A. October 1988,p. 32.

Alford, J.S., and Cline, F.L. Computer SystemValidation: Installation Qualification. September1990, p. 32.

Allen, B.R., and Luli, G.W. A Gradient-Feed Processfor E. coli Fermentations. November 1987, p. 38.

Amer, Gamal I. See Weil, Stephen.Anderson, Leonard. Viewpoint: Demystifying the

“New” Biology. March 1988, p. 16.Armiger, William B. See MacMichael, Gregory J.Athani, Anuradha, and Banakar, Umesh V. The

Development and Potential Uses of Biosensors.January 1990, p. 23.

Atkinson, T. See Hammond, P.M.Aversa, Catherine R. See Per, Steven R.

Bader, Frederic G.; Blum, Arthur; Garfinkle, Barry D.;MacFarlane, David; Massa, Tobias; and Copmann,Thomas L. Multiuse Manufacturing Facilities forBiologicals. September 1992, p. 32.

Bailey, F. James. See Maigetter, Robert Z.Bailey, Jr., John E.; Dibner, Mark D.; and Greis, Noel

P. Barriers to Success: Hurdles in the BiotechnologyRace. March 1991, p. 16.

Baker, William R. See Kleinert, Hollis D.Baldwin-Ferro, Alysia. See Rao, Patricia. Ball, Christopher. Thinking Outside the Lines:

Selecting a Contract Research Agency.November–December 1993, p. 42.

Ball, Christopher. Thinking Outside the Lines, Part 2:Working with a Contract Research Agency. May1994, p. 40.

Banakar, Umesh V. See Athani, Anuradha.Banakar, Umesh V. See Sanghvi, Pradeepkumar.Banks, Jim. See Wolber, Peter.Barry, Anne R., and Chojnacki, Robert. Biotechnology

Product Validation, Part 8: Chromatography Mediaand Column Qualification. November 1994, p. 43.

Bates, Doris J. A Matter of Degree? October 1991,p. 30.

Bates, Doris J. Viewpoint: Edwards Committee FinalReport. July–August 1991, p. 16.

Baumbach, George A., and Hammond, David J.Protein Purification Using Affinity LigandsDeduced from Peptide Libraries. May 1992, p. 24.

Bausch, James, and Sydor, Wasyl. Automated ProteinMicrosequencing: Using an Amino AcidHomopolymer as an Internal Standard. May 1989,p. 40.

Beatrice, Michael. See Hill, Donald.Beckman, Robert, J. Viewpoint: Managing

Organizational Growth. January–February 1993, p.20.

Behrens, Paul W., and Delente, Jacques J. Microalgaein the Pharmaceutical Industry. June 1991, p. 54.

Berzofsky, Ronald Lee; Scheible, S.; and Williams,Kevin L. Technical Note: Validation of EndotoxinRemoval from Parenteral Vial Closures. June 1994,p. 58.

Biedermann, Kirsten, and Nielsen, Bjarne Rønfeldt.Homogeneity Analysis of a Nuclease Secreted by E.Coli. June 1990, p. 34.

Bienz-Tadmor, Brigitta, and Brown, Jeffrey S.Biopharmaceuticals and Conventional Drugs:Comparing Development Times. March 1994, p. 44.

Bierley, Sarah T. See Poiley, Judith A.Bjurstrom, Edward E., and Coleman, Drew. Water for

Injection System Design. November 1987, p. 42.Bjurstrom, Edward E., and Coleman, Drew. Water

Systems for Biotechnology Facilities. September1987, p. 50.

Black, John. See Budnick, Michael O.Blum, Arthur. See Bader, Frederic G.Bogosian, Gregg. See Kane, James F.Booz, Martha L. A Practical Approach to the Analysis

of 2-D Gels. January 1989, p. 44.Borghese, Robert N. Troubleshooting Validation

Failures. March 1993, p. 28.Borghese, Robert N. Viewpoint: Quality Auditing as a

Tool — Increase Efficiency and Reduce Costs.October 1990, p. 14.

Boschetti, E. See Jungbauer, A.Bowers, Alan J. Going Public — Step by Step. October

1991, p. 44. Bowers, Alan J. Going Public — Why and When.

September 1991, p. 45.Brasker, John D.; Smith, Mark A.; and Zavela, David

A. Batch Process Automation Applied toRecombinant Fermentation Systems.November–December 1991, p. 28.

Bridgen, Pamela J. Viewpoint: A Look into the 1990s— Association of Biotechnology Companies. May1991, p. 15.

Broce, R. See Wyatt, D.E.Brotman, Harris F. See Farber, Michael B.Brown, Jeffrey S. See Bienz-Tadmor, Brigitta.Brown, Jim. See Schiff, Leonard J.Brown, Peter G. Peristaltic Pumps in Low-Pressure LC

Systems. March 1988, p. 46.Brown, Timothy A. See Tung, Amar S.Budnick, Michael O.; Cosenza, Todd A.; and Black,

John. Clearance of Adventitious Virus DuringBovine-Albumin Manufacture. October 1994, p. 32.

Bui, Phiet. See Gavit, Patrick. Burns, Donald A. Rapid Transit of Samples from

Fermentor to Analyzer. April 1988, p. 42.Burrill, G. Steven. Columnist. See Subject Index:

Business Matters Columns.

Cahn, F. See Adema, E.Cape, Ronald E. Viewpoint: Harmony Fellowships —

Fostering the International Growth ofBiotechnology. November 1987, p. 14.

Caple, M.V.; Fletcher, T.R.; Owens, W.J.; Harada, S.;Murphy, T.J.; and Walthall, B.J. Technical Note: ADual Formulation Serum-Free Media System. June1992, p. 52.

Carder, Elizabeth R. See Chew, Nancy J.Carey, Norman. Viewpoint: A Question of Balance —

Strategies for Growth in a Science-Based Industry.January 1990, p. 12.

Carlson, Karen. See Winter, Jennifer.Carpenter, John F. See Crowe, John H.Cartwright, Terence. See Monegier, Bertrand.Casey, Richard L. Viewpoint: Biotechnology

Bedfellows — Making Strategic Partnerships Work.November–December 1989, p. 18.

Chapman, J. See Sun, C.Chapman, K.G., and Harris, J.R. Computer System

Validation — Staying Current: Introduction. May1989, p. 30.

Charles, Kathleen G. See Pfund, Nancy E.Chasin, Mark; Lewis, Danny; and Langer, Robert.

Polyanhydrides for Controlled Drug Delivery.February 1988, p. 33.

Chassaigne, Patrick. Maximizing LIMSResults throughEffective Strategic Planning. June 1992, p. 48.

Chen, David. See Weaver, Kurt.Cherry, C.W. See Vasilevsky, M.Cherry, Robert S. Viewpoint: Engineering the Cell-

System Interface. July–August 1988, p. 14.Chew, Nancy J. Columnist. See Subject Index:

Regulatory Affairs Columns.Chojnacki, Robert. See Barry, Anne R.Chrisey, Linda A., and Hawkins, James W. Antisense

Technology: Principles and Prospects forTherapeutic Development. June 1991, p. 36.

Christiansen, Gary D. See Joner, Eva.Clapp, Kenneth P., and Ruel, Gregory J. Expert

Systems in Bioprocessing. February 1991, p. 28.Clerc, François Frédéric. See Monegier, Bertrand.Cline, F.L. See Alford, J.S.Cohen, Jack, and Jensen, David G. “Analysis of a

Career Change, Part 2: Reality Sets In” in ManagingYour Career. April 1994, p. 60.

Cohen, Jack, and Jensen, David G. “Career ChangeAnalysis, Part 1: Expectations” in Managing YourCareer. March 1994, p. 57.

Cohen, Richard, and Hoerner, Carol Lax. OccupationalHealth Perspective: Recombinant DNA Technology.June 1994, p. 28.

Coleman, Drew. See Bjurstrom, Edward E.Colli, Bart J.; Groisser, Debra; and DePaola, Karen.

Private Placement — A Viable Alternative to anIPO. April 1992, p. 43.

Collins, Paul J., and Krauss, Marc R. Quantitative 2-DElectrophoresis and Computer-Assisted Analysis.January 1989, p. 50.

Committee on Process Development andManufacturing, Biotechnology Division, BiologicalSection, Pharmaceutical Manufacturers Association.Assessment of Genetic Stability for BiotechnologyProducts. February 1991, p. 22.

Computer Systems Validation Committee,Pharmaceutical Researchers and Manufacturers ofAmerica. Computer System Validation: AuditingComputer Systems for Quality. September 1994, p.22.

Cook, Ronald M. See Lyttle, Matthew H.Cooney, Charles L. From Science to Technology. June

1993, p. 32.Copmann, Thomas L. See Bader, Frederic G.Corrado, Gail C. See Subject Index: Regulatory Affairs

Columns.Cortessis, G.P., and Proby, C.M. Airlift Bioreactors for

Production of Monoclonal Antibodies. November1987, p. 30.

Cosenza, Todd A. See Budnick, Michael O.

2 BioPharm Index


Costa, Daniel W., and Via III, John W. ConfigurableSoftware Validation for Batch Processes. May 1991,p. 40.

Cottam, A. See Titchener-Hooker, N.J.Cramer, Steven M. See Gerstner, Joseph A.Crommelin, D.J.A. See Talsma, H.Crouch, Madge L. See Subject Index: Regulatory

Affairs Columns.Crowe, John H.; Crowe, Lois M.; and Carpenter, John

F. Preserving Dry Biomaterials: The WaterReplacement Hypothesis, Part 1. April 1993, p. 28.

Crowe, John H.; Crowe, Lois M.; and Carpenter, JohnF. Preserving Dry Biomaterials: The WaterReplacement Hypothesis, Part 2. May 1993, p. 40.

Crowe, Lois M. See Crowe, John H.

Deer, Frank. See Young, Delano V.Del Ciello, Robert. See Robins, Donald.del Valle, Manuel A. HVAC Systems for

Biopharmaceutical Manufacturing Plants. April1989, p. 26.

DePaola, Karen. See Colli, Bart J.DeSain, Carol, and Sutton, Charmaine Vercimak.

Validation for Device and DiagnosticManufacturers, Part 1: Basic Principles. October1994, p. 46.

DeSain, Carol. Columnist. See Subject Index:Documentation Basics Columns.

Dibner, Mark D. Drug Regulation in Japan: CanForeign Companies Play on Their Field? October1989, p. 34.

Dibner, Mark D. See Bailey, Jr., John E.Dibner, Mark D. U.S. Biotechnology and

Pharmaceuticals. October 1992, p. 24.Dibner, Mark D., and Osterhaus, Jane T.

Biotechnology and Pharmaceuticals: MergingTogether. September 1987, p. 56.

Dibner, Mark D., and White, R. Steven. Biotechnologyin the United States and Japan: Who’s on First?February 1989, p. 22.

Dillon, C.P.; Rahoi, D.W.; and Tuthill, A.H. StainlessSteels for Bioprocessing, Part 1: MaterialsSelection. April 1992, p. 38.

Dillon, C.P.; Rahoi, D.W.; and Tuthill, A.H. StainlessSteels for Bioprocessing, Part 2: Classes of Alloys.May 1992, p. 32.

Dillon, C.P.; Rahoi, D.W.; and Tuthill, A.H. StainlessSteels for Bioprocessing, Part 3: CorrosionPhenomena. June 1992, p. 40.

Dillon, C.P.; Rahoi, D.W.; and Tuthill, A.H. StainlessSteels for Bioprocessing, Part 4: Procurement,QA/QC. July–August 1992, p. 31.

Dixon, Anne Marie. Clean Room Management.October 1988, p. 28.

Dobbels, Susan. See Young, Delano V.Dosmar, Michael. See Wolber, Peter.Dougherty, John J. See Strege, Mark A.Doyle, Kevin R. See Duffy, Stephen A.Drohan, William N. See Wagner, Barbara H.Drost, R.A. An Exercise in Collaboration: Registration

of Biotechnology-Derived Pharmaceuticals in theEEC. September 1990, p. 28.

du Moulin, Gary C. See Janoschek, Robert.du Moulin, Gary C.; Hamilton, Dylan L.; Price, John

E.; Kosik, Zenobia J.; Liu, Y.-S. Victor; andOsband, Michael E. Quality Assurance and QualityControl (QA/QC) in Biocare: AutolymphocyteTherapy as a Model. July–August 1990, p. 30.

du Moulin, Gary C.; Price, John E.; Shen, Yuan-Jin;and Osband, Michael E. Use of the LimulusAmebocyte Lysate (LAL) Assay in Living Cell

Therapies. March 1992, p. 32. Duffy, Stephen A.; Moellering, Bill J.; Prior, Garance

M.; Doyle, Kevin R.; and Prior, Christopher P.Recovery of Therapeutic-Grade Antibodies: ProteinA and Ion-Exchange Chromatography. June 1989,p. 34.

Dunn, Michael. See Saxena, Vinit.Dwyer, James L. Small Molecule Membrane

Separation Processes. September 1987, p. 71.

Eliezer, Edi D. Bioprocess Development for Cost-Effective Facility Design. May 1993, p. 24.

Elwell, Lynn. See Weaver, Kurt.Ensley, Burt D. Viewpoint: Opportunistic Opposition

to Biotechnology. March 1993, p. 20.Epstein, David A. See Fike, Richard M.Ervin, Wes. Viewpoint: Biopharmaceutical

Manufacturing and the Local Community —Education as the Key to Harmony. June 1990, p. 14.

Fahrner, Robert. New Role for Pilot Plants in ProductDevelopment. April 1993, p. 34.

Fahrner, Robert. Viewpoint: Making ConcurrentProcess Development Work. November–December1993, p. 18.

Familletti, Philip C. Gel-Immobilized Cell Culture forMonoclonal Antibody Production. November 1987,p. 48.

Farber, Michael B., and Brotman, Harris F. The Scopeof Patent Protection for Physiologically ImportantProteins and Peptides. April 1990, p. 22.

Feldman, Martha A. See Subject Index: RegulatoryAffairs Columns.

Fenno, James; Luczak, Janet; Moore, Alan; Poiley,Judy; Raineri, Ronald; and Whiteman, Mary. TheCharacterization of Transformed Cell Substrates.September 1988, p. 36.

Festen, R. See Keathley, J.D.Fike, Richard; Kubiak, James; Price, Paul; and Jayme,

David. Feeding Strategies for Enhanced HybridomaProductivity: Automated ConcentrateSupplementation. October 1993, p. 49.

Fike, Richard M.; Pfohl, Jeffrey L.; Epstein, David A.;Jayme, David W.; and Weiss, Stefan. HybridomaGrowth and Monoclonal Antibody Production inProtein-Free Hybridoma Medium. March 1991,p. 26.

Fish, N.M. See Titchener-Hooker, N.J.Fleitman, Jeffrey S. See Lidgate, Deborah M.Fletcher, T.R. See Caple, M.V.Fouron, Yves. Protein Production from Animal Cells:

The Role of Contract Manufacturers. June 1988,p. 34.

Franks, Felix; Hatley, Ross H.M.; and Mathias, SheilaF. Materials Science and the Production of Shelf-Stable Biologicals. October 1991, p. 38.

Fry, Holly H. See Seely, Robert J.Fu, Roger C. See Lidgate, Deborah M.Furst, Allen. See Wert, Karen.

Gaden, Jr., Elmer L. Viewpoint: At the End of theBeginning. September 1988, p. 18.

Gardiner, S.A.M. See Titchener-Hooker, N.J.Garfinkle, Barry D. See Bader, Frederic G.Gavit, Patrick; Walker, Mike; Wheeler, Tim; Bui,

Phiet; Lei, Shau-Ping; and Weickmann, Joachim.Purification of a Mouse–Human Chimeric FabSecreted from E. coli. January–February 1992,p. 28.

Gerstner, Joseph A., and Cramer, Steven M. TechnicalNote: Heparin as a Nontoxic Displacer for Anion-

Exchange Protein Displacement Systems.November–December 1992, p. 42.

Ghignone, Albert A. See Subject Index: RegulatoryAffairs Columns.

Gibbs, Jeffrey N. See Subject Index: RegulatoryAffairs Columns.

Gilbert, Carson D., and Chew, Nancy J. “Are UserFees Meeting Their Intended Purpose?” inRegulatory Affairs. July–August 1994, p. 20.

Gilbert, Carson, and Chew, Nancy J. “The ContinuingDebate: Making Health Care Reform Work forYou,” in Regulatory Affairs. November 1994, p. 16.

Gillies, Stephen D. See Young, Delano V.Ginev, Emil G. Updating USP Waters Monographs

and Tests: PMA-Proposed Changes. September1993, p. 52.

Giorgio, Robert J. Facilities for Large-Scale ProteinPurification and Isolation. May 1988, p. 38.

Goren, Leonard J. Computer System Validation, Part I:Testing and Verification of Applications Software.November–December 1988, p. 28.

Goren, Leonard J. Computer System Validation, PartII: Evaluating Vendor Software. February 1989,p. 38.

Grave, E. Material Selection for Components in aPilot-Plant Fermentation System. January 1988,p. 22.

Green, Brian. See Monegier, Bertrand.Green, W. Richard. See Strege, Mark A.Gregory, Gillian. See Subject Index: Regulatory

Affairs Columns.Greis, Noel P. See Bailey Jr., John E.Griffen, Susan Haberman; Irving, Thomas L.; and

Sung, Lawrence M. Will You Be Liable for PatentInfringement? July–August 1992, p. 26.

Grigonis, Jr., George J., and Wyrick, Michael L.Computer System Validation: Auditing ComputerSystems for Quality. September 1994, p. 22.

Gritsis, D. See Titchener-Hooker, N.J.Groisser, Debra. See Colli, Bart J.Grun, Janet B. See White, Elizabeth M.Grun, Janet B.; White, Elizabeth M.; and Sito,

Alexander F. Viral Removal/Inactivation byPurification of Biopharmaceuticals.November–December 1992, p. 22.

Guerrier, L. See Jungbauer, A.Guzman, Norberto A.; Hernandez, Luis; and Hoebel,

Bartley G. Capillary Electrophoresis: A New Era inMicroseparations. January 1989, p. 22.

Hageman, Thomas C. An Analysis of Clearance FactorMeasurements Performed by Spiking Experiments.July–August 1991, p. 39.

Hamilton, Dylan L. See du Moulin, Gary C.Hammond, David J. See Baumbach, George A.Hammond, P.M.; Atkinson, T.; Sherwood, R.F.; and

Scawen, M.D. Manufacturing New-GenerationProteins, Part I: The Technology. April 1991, p. 16.

Hammond, P.M.; Atkinson, T.; Sherwood, R.F.; andScawen, M.D. Manufacturing New-GenerationProteins, Part II: Process Design and QualityManagement. May 1991, p. 30.

Hamrell, Michael R. See Subject Index: RegulatoryAffairs Columns.

Hanigan, Eileen. See Rao, Patricia. Hanna, Lewis S.; Pine, Perla; Reuzinsky, Gary; Nigam,

Somesh; and Omstead, Daniel R. RemovingSpecific Cell Culture Contaminants in a MAbPurification Process. October 1991, p. 33.

Harada, S. See Caple, M.V.Hardy, Mark R. See Moellering, Bill J.

BioPharm Index 3


Harris, J.R. See Chapman, K.G.Harrison, Frederick G. See Subject Index: Regulatory

Affairs Columns.Hatley, Ross H.M. See Franks, Felix. Hawkins, James W. See Chrisey, Linda A.Hayman, Edward G. See Tung, Amar S.Hernandez, Luis. See Guzman, Norberto A.Hess, Arye. An Integrated Approach to Validation.

March 1988, p. 42.Hickey, E.W. See Meeker, J.T. Hill, Donald, and Beatrice, Michael. Biotechnology

Facility Requirements, Part I: Facility and SystemsDesign. October 1989, p. 20.

Hill, Donald, and Beatrice, Michael. BiotechnologyFacility Requirements, Part II: Operating Proceduresand Validation. November–December 1989, p. 28.

Hillesund, Tove R. See Poiley, Judith A.Hinman, Donald J. See Subject Index: Regulatory

Affairs Columns.Hoare, M. See Titchener-Hooker, N.J.Hochkeppel, H.K. See Horisberger, M.A.Hoebel, Bartley G. See Guzman, Norberto A.Hoerner, Carol Lax. See Cohen, Richard.Horisberger, M.A., and Hochkeppel, H.K. Interferon

Alpha Hybrids. March 1994, p. 50.Howard Jr., G. See Meeker, J.T. Hughes, Jon, and Qoronfleh, M. Walid. Perspectives in

Plant Genetic Engineering and Biopharmacy. May1991, p. 18.

Hyer Jr., Warren C. Viewpoint: Sailing with the Tide.January 1988, p. 14.

Idrovo, Javier H. See Remer, Donald S.Irving, Thomas L. See Griffen, Susan Haberman.

Janoschek, Robert, and du Moulin, Gary C. UltravioletDisinfection in Biotechnology: Myth versusPractice. January 1994, p. 24.

Jayme, David W. See Fike, Richard M.Jem, Kwanmin Jim. Scale-Down Techniques for

Fermentation. March 1989, p. 30.Jensen, David G. Columnist. See Subject Index:

Managing Your Career Columns.Johansson, Bo-Lennart. Determination of Leakage

Products from Chromatographic Media Aimed forProtein Purification. April 1992, p. 34.

Johnson, Roger W. Quality Assurance of Cell Cultures.January 1988, p. 43.

Johnson, Roger W. Quality Assurance of TissueCulture Media Used in the Biotechnology Industry.February 1990, p. 40.

Johnston, Paul D. See Per, Steven R.Joner, Eva, and Christiansen, Gary D. Hybridoma

Technology Products: Required Virus Testing.September 1988, p. 50.

Jungbauer, A.; Lettner, H.P.; Guerrier, L.; andBoschetti, E. Chemical Sanitization in ProcessChromatography, Part 2: In Situ Treatment ofPacked Columns and Long-Term Stability ofResins. July–August 1994, p. 37.

Jungbauer, Alois, and Lettner, Hans P. ChemicalDisinfection of Chromatographic Resins, Part 1:Preliminary Studies and Microbial Kinetics. June1994, p. 46.

Kane, James F., and Bogosian, Gregg. BovineSomatotropin Production: Selecting the Best Host-Vector System. November 1987, p. 26.

Keathley, J.D.. See Wyatt, D.E.Keathley, J.D.; Wyatt, D.E.; Williams, C.M.; Festen,

R.; and Maben, C. Is There Life after Irradiation?

Part 2: Gamma-Irradiated FBS in Cell Culture.July–August 1993, p. 46.

Keating, P.; Levy, R.; Payne, M.; Proulx, S.; Rowe, P.;and Pearl, S. Performance Testing of Membrane-Based Filters Used in the Filtration of IndustrialFermentation Air. January–February 1992, p. 36.

Keer, Donald R. Prescription for Finding a StrategicPartner. November 1994, p. 34.

Keith, Michael G. See Naglak, Thomas J.Kelter, S. Louis. An HVAC Primer for

Biopharmaceutical Facilities. May 1988, p. 30.Kerr, Andrew P.; Klotz, Lynn C.; Morris, Charles R.;

and Schatz, Robert. An Early Warning Tool forPharmaceutical Development. March 1992, p. 24.

Kerr, Andrew P.; Klotz, Lynn C.; Morris, Charles R.;and Schatz, Robert. Partnering and Investing. June1991, p. 50.

Kimball, Barbara K. Control Charts for BioprocessControl. June 1988, p. 46.

King, Louise. See Young, Delano V.Kirschstein, Ruth L. Viewpoint: NIH Support of

Biotechnology. February 1988, p. 14.Kleinert, Hollis D.; Baker, William R.; and Stein,

Herman H. Orally Bioavailable PeptidelikeMolecules: A Case History. January–February 1993,p. 36.

Klimchak, Robert J., and Lenk, Robert P. Scale-Up ofLiposome Products. February 1988, p. 18.

Klotz, Lynn C. See Kerr, Andrew P.Kopasz, Theresa L. See Per, Steven R.Kosecki, Robert. Recirculating Isoelectric Focusing: A

System for Protein Separations. June 1988, p. 28.Kosik, Zenobia J. See du Moulin, Gary C.Kossik, John and Miller, Geof. Viewpoint:

Manufacturing — The Next Frontier forBiotechnology, September 1993, p. 22.

Kovaly, Kenneth A. Using Other People’s Technology(OPT). June 1990, p. 44.

Krause, Richard J. See MacMichael, Gregory J.Krauss, Marc R. See Collins, Paul J.Kroon, Daniel. See Rao, Patricia. Krueger, Joanna K.; Kulke, Matthew H.; Schutt, C.;

and Stock, Jeff. Protein Inclusion Body Formationand Purification. March 1989, p. 40.

Kubiak, James. See Fike, Richard.Kulke, Matthew H. See Krueger, Joanna K.Kurtz, Jay. See Stark, Stanley.

Lage, Agustin. Viewpoint: Biotechnology — OfferingNew Opportunities for Developing Countries. June1994, p. 18.

Lagu, Avinash L. See Strege, Mark A.Lambert, K.J. See Subject Index: Regulatory Affairs

Columns.Langer, Robert. See Chasin, Mark.Lebherz III, William B. Batch Production of

Monoclonal Antibody by Large-Scale SuspensionCulture. February 1988, p. 22.

Lee, George F. See MacMichael, Gregory J.Lee, John Y. Environmental Requirements for Clean

Rooms. February 1989, p. 42.Lee, Kenneth B. See Subject Index: Regulatory Affairs

Columns.Lee, Vincent H.L. Oral Route of Peptide and Protein

Drug Delivery. July–August 1992, p. 39.Lee, Vincent H.L. Peptide and Protein Drug Delivery

Systems. March 1988, p. 24.Lee, Vincent H.L. Trends in Peptide and Protein Drug

Delivery. March 1991, p. 22.Lee, William A. Permeation Enhancers for the Nasal

Delivery of Protein and Peptide Therapeutics.

November–December 1990, p. 22.Lee, William A., and Longenecker, John P. Intranasal

Delivery of Proteins and Peptides. April 1988, p. 30.Lei, Shau-Ping. See Gavit, Patrick. Lenk, Robert P. See Klimchak, Robert J.Leonèsio, Paul J., and Chew, Nancy J. “The Supplier’s

Role in Validation” in Regulatory Affairs. May1994, p. 28.

Lettner, H.P. See Jungbauer, A.Levchuk, John W., and Lord, Anthony G. Personnel

Issues in Aseptic Processing. September 1989,p. 34.

Levine, Harry and Slade, Louise. Another View ofTrehalose for Drying and Stabilizing BiologicalMaterials. May 1992, p. 36.

Levine, Howard L. See Ransohoff, Tom C.Levy, Peter F., and Sheehan, John J. Performance

Characteristics of Polysulfone and CelluloseMembranes for the Ultrafiltration of BiologicalProcess Streams. April 1991, p. 24.

Levy, R. See Keating, P. Levy, Richard V. See Roche, Kerry L.Levy, Ronald S. Efficient Calcitonin Production. May

1993, p. 36.Lewis, Danny. See Chasin, Mark.Lidgate, Deborah M.; Fu, Roger C.; and Fleitman,

Jeffrey S. Using a Microfluidizer to ManufactureParenteral Emulsions. October 1989, p. 28.

Liu, Y.-S. Victor. See du Moulin, Gary C.Longenecker, John P. See Lee, William A.Lord, Anthony G. See Levchuk, John W.Luczak, Janet. See Fenno, James.Luli, G.W. See Allen, B.R.Lyttle, Matthew H.; Cook, Ronald M.; and Wright,

Peter B. Large-Scale Automated DNA Synthesis.July–August 1988, p. 34.

Maben, C. See Keathley, J.D.Maccecchini, Maria-Luisa. International Strategic

Alliances. July–August 1991, p. 28.MacFarlane, David. See Bader, Frederic G.Mackler, Scott E. Modular Design and Construction,

Part 1: Project Planning and Design. September1992, p. 42.

Mackler, Scott E. Modular Design and Construction,Part 2: Installation and Maintenance. October 1992,p. 40.

MacLean, D.J. See Subject Index: Regulatory AffairsColumns.

MacMichael, Gregory J.; Armiger, William B.; Lee,George F.; and Krause, Richard J. FluorescentMeasurement of Biomass in Mammalian CellCultures. May 1988, p. 48.

Maffett, Stephanie K. See Zakas, Dennis L.Mahar, J.T. Scale-Up and Validation of Sedimentation

Centrifuges, Part 1: Scale-Up. September 1993,p. 42.

Mahar, J.T. Scale-Up and Validation of SedimentationCentrifuges, Part 2: Validation. October 1993, p. 38.

Maigetter, Robert Z.; Bailey, F. James; and Miller,Brinton. Safe Handling of Microorganisms inSmall- and Large-Scale BL-3 FermentationFacilities. February 1990, p. 22.

Makowski, Mary. See Rao, Patricia. Mannweiler, K. See Titchener-Hooker, N.J.Manteuffel, Richard L. See Martin, Jerold M.Manuso, James S.J. Finding the Right Scientist:

Working with a Headhunter. October 1989, p. 44.Marino, Margaret Habash. Expression Systems for

Heterologous Protein Production. July–August1989, p. 18.

4 BioPharm Index


Martin, J.M. See Meeker, J.T. Martin, Jerold M., and Manteuffel, Richard L. Protein

Recovery from Effluents of MicroporousMembranes. November–December 1988, p. 20.

Massa, Tobias. See Bader, Frederic G.Mathias, Sheila F. See Franks, Felix. McCurdy, Debra A. See Chew, Nancy J.McEntire, John, See Akers, James.McEntire, John. Biotechnology Product Validation,

Part 5: Selection and Validation of AnalyticalTechniques. June 1994, p. 68.

McGarrity, Gerard J. Viewpoint: Cell CultureStandardization. May 1988, p. 14.

McMillen, Janis K. See Subject Index: RegulatoryAffairs Columns.

Meagher, M.M. Installation of a Non–Steam-in-PlaceDisk-Stack Centrifuge for Biological Applications.September 1994, p. 32.

Meagher, Michael M. Design of a University-Based,Biosafety Level 2, Large-Scale FermentationFacility. October 1992, p. 30.

Meeker, J.T.; Hickey, E.W.; Martin, J.M.; andHoward, Jr., G. Technical Note: A QuantitativeMethod for Challenging 0.1 mm Rated Filters withA. laidlawii. March 1992, p. 41.

Mendell, Steven C. Viewpoint: Corporate Partnering— One Company’s Perspective. June 1988, p. 16.

Menon, Gopi R. Carbon Filters, Sand Filters:Technology and Application of Water PretreatmentSystems. March 1990, p. 33.

Menon, Gopi R. “Rouge” and Its Removal from High-Purity Water Systems. June 1990, p. 40.

Meyer, Eric. See Rao, Patricia. Michaels, Stephen L. Clean-Water Permeability As a

Determinant of Cleaning Efficacy in Tangential-Flow Filtration Systems. October 1994, p. 38.

Miller, Brinton. See Maigetter, Robert Z.Miller, Geof. See Kossik, John.Mintz, Gilbert R. Technical Note: An Irreversible

Serine Protease Inhibitor. March 1993, p. 34.Moellering, Bill J. See Duffy, Stephen A.Moellering, Bill J., and Prior, Christopher P.

Separating Clinical-Grade Chimeric Antibodiesfrom Serum-Derived Immunoglobulins. January1990, p. 34.

Moellering, Bill J.; Tedesco, John L.; Townsend, R.Reid; Hardy, Mark R.; Scott, Randy W.; and Prior,Christopher P. Electrophoretic Differences in aMAb Expressed in Three Media. February 1990,p. 30.

Monegier, Bertrand; Clerc, François Frédéric; VanDorsselaer, Alain; Vuilhorgne, Marc; Green, Brian;and Cartwright, Terence. Using Mass Spectrometryto Characterize Recombinant Proteins.November–December 1990, p. 26.

Montgomery, S. Anne. Professional Societies andAssociations. January 1991, p. 37.

Montgomery, S. Anne. See Winter, Jennifer.Monticello, Thomas M. See Poiley, Judith A.Moore, Alan. See Fenno, James.Moore, W. Alan. See Schiff, Leonard J.Morgan, Richard A. Human Gene Therapy.

January–February 1993, p. 32.Morris, Charles R. See Kerr, Andrew P.Murphy, Jeanette L., and Rumorre, Martha M. U.S.

Legislation to Protect Biotechnology IntellectualProperty. November–December 1992, p. 22.

Murphy, Marilee K. See Ransohoff, Tom C.Murphy, T.J. See Caple, M.V.

Naglak, Thomas J.; Keith, Michael G.; and Omstead,

Daniel R. Validation of Fermentation Processes.July–August 1994, p. 28.

Naveh, David. Industrial-Scale DownstreamProcessing of Biotechnology Products. May 1990,p. 28.

Naveh, David. Recombinant DNA Proteins: Scale-UpStrategies for Purification. September 1987, p. 34.

Nellis, David E. Training People to TakeResponsibility for Quality. October 1988, p. 24.

Nelson, Earl. See Poiley, Judith A.Nelson, Kim L. Industrial-Scale Mammalian Cell

Culture, Part I: Bioreactor Design Considerations.February 1988, p. 42.

Nelson, Kim L. Industrial-Scale Mammalian CellCulture, Part II: Design and Scale-Up. March 1988,p. 34.

Neway, Justin. Viewpoint: A Risk-Free World? April1993, p. 16.

Nielsen, Bjarne Rønfeldt. See Biedermann, Kirsten.Nigam, Somesh. See Hanna, Lewis S. Notarian, Roger. Installation and Operational

Qualification of PLC Systems. October 1993, p. 46.Numsuwan, Vanchai. See Rao, Patricia.

O’Donnell, Kathleen D. See Alford, Bernadette L.Odum, Jeffery N. Building Quality in GMP Facilities.

June 1993, p. 42.Odum, Jeffery N. Developing a Program for

Biopharmaceutical Facility Design. May 1994, p.36.

Odum, Jeffery N. GMP Compliance in theArchitecture and Construction of BiopharmaceuticalManufacturing Facilities. January–February 1993, p.42.

Odum, Jeffery N. Sanitary Piping System Installationand GMP Compliance. July–August 1992, p. 36.

Oldham, Robert K. Viewpoint: Cancer Research: APublic Trust. March 1991, p. 8.

Oldrich, R. See Titchener-Hooker, N.J.Omstead, Daniel R. See Hanna, Lewis S. Omstead, Daniel R. See Naglak, Thomas J.Orelli, Carolyn M. Creative Ideas for GMP Training.

September 1991, p. 42.Orelli, Carolyn M. Good Manufacturing Practices

Training. April 1988, p. 38.Osband, Michael E. See du Moulin, Gary C.Osterhaus, Jane T. See Dibner, Mark D.Owens, W.J. See Caple, M.V.

Payne, M. See Keating, P. Payne, Robert W. Trade-Secret Protection. February

1988, p. 47.Payne, Robert W. Trade Secret Protection.

January–February 1992, p. 42. Pearl, S. See Keating, P. Pearson III, Frederick. See Weary, Marlys.Pennino, Donald J. Free-Zone Capillary

Electrophoresis: A Simple Computer Program forPredicting Peptide Migration Times. September1989, p. 41.

Per, Steven R.; Aversa, Catherine R.; Johnston, PaulD.; Kopasz, Theresa L.; and Sito, Alexander F.Determining Residual DNA Levels: Comparison ofHybridization with an Alternative Method.November–December 1993, p. 34.

Perkowski, Casimir A. Controlling Contamination inBioprocessing. September 1987, p. 62.

Persiani, Stefano. See Shen, Wei-Chiang.Petrossian, Ashot; Smart, Nigel; and Proietto, Robert

P. Designing a Flexible Facility forBiopharmaceuticals. July/August 1993, p. 40.

Pfohl, Jeffrey L. See Fike, Richard M.Pfund, Nancy E. Viewpoint: The Great BioSeparations

Debate — Sound and Fury, Signifying . . . ? May1994, p. 16.

Pfund, Nancy E., and Charles, Kathleen G. SeparationsTechnology Outlook, Part I: The Challenges of theBiopharmaceutical Industry. November 1987, p. 20.

Pfund, Nancy E., and Charles, Kathleen G. SeparationsTechnology Outlook, Part II: Improved Recoveryand Greater Purity. January 1988, p. 29.

Pikal, Michael J. Freeze-Drying of Proteins, Part I:Process Design. September 1990, p. 18.

Pikal, Michael J. Freeze-Drying of Proteins, Part II:Formulation Selection. October 1990, p. 26.

Pine, Perla. See Hanna, Lewis S. Poiley, Judith A.; Bierley, Sarah T.; Hillesund, Tove

R.; Nelson, Earl, Monticello; Thomas M.; andRaineri, Ronald. Methods for Estimating RetroviralBurden. May 1994, p. 32.

Poiley, Judy. See Fenno, James.Price, John E. See du Moulin, Gary C.Price, Paul. See Fike, Richard.Prior, Christopher P. See Duffy, Stephen A.Prior, Christopher P. See Moellering, Bill J.Prior, Garance M. See Duffy, Stephen A.Proby, C.M. See Cortessis, G.P.Proietto, Robert P. See Petrossian, Ashot.Proulx, S. See Keating, P.

Qoronfleh, M. Walid. See Hughes, Jon.Quezada, Fernando. See Watson, Greg.

Rahoi, D.W. See Dillon, C.P.Raineri, Ronald. See Fenno, James.Raineri, Ronald. See Poiley, Judith A.Raju, R.R. See Sadana, Ajit.Ransohoff, Tom C.; Murphy, Marilee K.; and Levine,

Howard L. Automation of BiopharmaceuticalPurification Processes. March 1990, p. 20.

Rao, Patricia; Williams, Allan; Baldwin-Ferro, Alysia;Hanigan, Eileen; Kroon, Daniel; Makowski, Mary;Meyer, Eric; Numsuwan, Vanchai; Rubin, Ellen;and Tran, An. C-Terminal Modification Occurs inTissue Culture Produced OKT3. November–Decem-ber 1991, p. 38.

Ray, Nitya G. See Tung, Amar S.Ray, Paul. See Weaver, Kurt.Regnier, Fred E. Peptide Mapping, Part I. January

1988, p. 19.Regnier, Fred E. Peptide Mapping, Part II. February

1988, p. 16.Remer, Donald S., and Idrovo, Javier H. Cost-

Estimating Factors for Biopharmaceutical ProcessEquipment. October 1990, p. 36.

Reuzinsky, Gary. See Hanna, Lewis S.Robbins-Roth, Cynthia. Viewpoint: Matching Your

Science to the Market. September 1992, p. 18.Robins, Donald, and Del Ciello, Robert. To Renovate

or Build New: Guidelines for EvaluatingConstruction Alternatives. January 1988, p. 34.

Roche, Kerry L., and Levy, Richard V. Methods Usedto Validate Microporous Membranes for theRemoval of Mycoplasma. April 1992, p. 22.

Roh, Mark S. FDA’s Small Business AssistanceProgram. January–February 1992, p. 26.

Rosa, Margaret D. Viewpoint: Serum Substitutes — IsThere a Solution? March 1989, p. 16.

Rosen, Ira G. DNA Probes in Infectious DiseaseDiagnosis. September 1987, p. 31.

Roser, Bruce. Trehalose Drying: A Novel Replacement

BioPharm Index 5


for Freeze-Drying. September 1991, p. 47.Rosser, Martin. Draft Guidelines on Good Automated

Manufacturing Practice: A Conference Report. April1994, p. 28

Rowe, P. See Keating, P. Rubin, Ellen. See Rao, Patricia. Rudge, Scott R. See Seely, Robert J.Ruel, Gregory J. See Clapp, Kenneth P.Rumore, Martha M. See Murphy, Jeanette L.Rund, Robert C. Viewpoint: Test Kit Endorsements —

A Dilemma Facing Us All. October 1988, p. 14.Runstadler Jr., Peter W. See Tung, Amar S.Ryan, Timothy W. Viewpoint: Surviving and Thriving

in Quality Control. May 1993, p. 16.

Sadana, Ajit, and Raju, R.R. Bioseparation andPurification of Proteins: An Analysis of NovelTechniques and Inactivating Influences. May 1990,p. 53.

Sadana, Ajit. Bioseparation Steps for Proteins andOther Biological Products, Part 1: Cell Disruption.March 1994, p. 26.

Sadana, Ajit. Bioseparation Steps in ProcessingProteins and Other Biological Products, Part 2:Initial Fractionation. April 1994, p. 34.

Sadana, Ajit. Protein Inactivation during DownstreamSeparation, Part I: The Processes. April 1989, p. 14.

Sadana, Ajit. Protein Inactivation during DownstreamSeparation, Part II: The Parameters. May 1989,p. 20.

Sammons, David W. See Sharnez, Rizwan.Sample, Johanna vG. See Tung, Amar S.Sanghvi, Pradeepkumar, and Banakar, Umesh V.

Ultrasonics: Principles and BiomedicalApplications. September 1991, p. 32.

Savol, Rosanne M. See Subject Index: RegulatoryAffairs Columns.

Saxena, Sanjeev. See Saxena, Vinit.Saxena, Vinit; Subramanian, K.; Saxena, Sanjeev; and

Dunn, Michael. Production-Scale Radial FlowChromatography. March 1989, p. 46.

Scawen, M.D. See Hammond, P.M.Schatz, Robert. See Kerr, Andrew P.Scheible, S. See Berzofsky, Ronald Lee.Schiff, Leonard J.; Moore, W. Alan; Brown, Jim; and

Wisher, Martin H. Lot Release — Final ProductSafety Testing for Biologics. June 1992, p. 36.

Schlom, Jeffrey. Monoclonal Antibodies in CancerTherapy: The Present and the Future. September1988, p. 44.

Schutt, C. See Krueger, Joanna K.Scotland, Richard A. See Subject Index: Regulatory

Affairs Columns.Scott, Randy W. See Moellering, Bill J.Seegers, Richard M. Shock Waves at Cetus: Repair,

Validation Confirmation, Preparing for the Future.April 1990, p. 28.

Seely, Robert J.; Wight, Hugh D.; Fry, Holly H.;Rudge, Scott R.; and Slaff, Geoffery F.Biotechnology Product Validation, Part 7:Validation of Chromatography Resin Useful Life.September 1994, p. 41.

Sharnez, Rizwan, and Sammons, David W. ContinuousFlow Electrophoresis: Resolving Real and ApparentHeterogeneity. January 1989, p. 54.

Sheehan, John J. See Levy, Peter F.Shen, Wei-Chiang; Persiani, Stefano; and Srivastava,

Krishna. Chemical Linkages in Drug-AntibodyConjugation. January 1990, p. 16.

Shen, Yuan-Jin. See du Moulin, Gary C. Sherman, Michael I. Oligonucleotide-Based

Therapeutics. September 1993, p. 38.Sherwood, R.F. See Hammond, P.M.Shnek, D. See Adema, E.Sinclair, P.A. See Titchener-Hooker, N.J.Sinskey, A.J. See Adema, E.Sito, Alexander F. See Per, Steven R.Sito, Alexander F. See White, Elizabeth M. and Grun,

Janet B.Skibo, Andrew D. Project Management and

Contracting Issues, Part I: Project TeamDevelopment. April 1989, p. 46.

Skibo, Andrew D. Project Management andContracting Issues, Part II: Project ScopeDevelopment. May 1989, p. 24.

Skibo, Andrew D. Project Management andContracting Issues, Part III: Contracting Format andContractor Selection. July–August 1989, p. 34.

Slade, Louise. See Levine, Harry.Slaff, Geoffery F. See Seely, Robert J.Small, William E. Viewpoint: Biotechnology in the

’90s. May 1992, p. 17.Smart, Nigel. See Petrossian, Ashot.Smith, Mark A. See Brasker, John D. Smith, Timothy J. Technical Note: Calcium Alginate

Hydrogel As a Matrix for Enteric Delivery ofNucleic Acids. April 1994, p. 54.

Sofer, Gail. Biotechnology Product Validation, Part 4:Clearance of Impurities from Protein and PeptideBiotherapeutics. May 1994, p. 46.

Sofer, Gail. See Adner, Niklas.Sofer, Gail. See Akers, James.Srigley, William R. See Tolbert, William R.Srivastava, Krishna. See Shen, Wei-Chiang.Stark, Stanley, and Kurtz, Jay. Design and

Environmental Considerations for the ModernResearch Laboratory. January 1994, p. 32.

Stein, Herman H. See Kleinert, Hollis D.Stein, Stanley. Primary Structure Analysis of

Recombinant Proteins. February 1989, p. 30.Stock, Jeff. See Krueger, Joanna K.Stoudt, Drew R. Compliance and Preparation for FDA

Inspections. January 1988, p. 39.Strattan, Charles E. Cyclodextrins and Biological

Macromolecules. November–December 1991, p. 44. Strege, Mark A.; Dougherty, John J.; Green, W.

Richard; and Lagu, Avinash L. Technical Note:Total Protein Analysis of Swab Samples for theCleaning Validation of Bioprocess Equipment.November 1994, p. 40.

Subak, Jr., E.J. Computer System Validation —Staying Current: Software Development TestingStrategies. September 1989, p. 24.

Subramanian, K. See Saxena, Vinit.Sun, C., and Chapman, J. Propagation of Human

Immunodeficiency Virus in Flexible Tissue CultureVessels. April 1991, p. 34.

Sun, Chong-Son. See White, Elizabeth M.Sung, Lawrence M. See Griffen, Susan Haberman.Sutton, Charmaine Vercimak. See DeSain, Carol.Sydor, Wasyl. See Bausch, James.

Talsma, H., and Crommelin, D.J.A. Liposomes asDrug Delivery Systems, Part 1: Preparation. October1992, p. 36.

Talsma, H., and Crommelin, D.J.A. Liposomes asDrug Delivery Systems, Part 2: Characterization.November–December 1992, p. 38.

Talsma, H. and Crommelin, D.J.A. Liposomes as DrugDelivery Systems, Part 3: Stabilization. March1993, p. 40.

Tedesco, John L. See Moellering, Bill J.

Thompson, Kent. See Subject Index: Business MattersColumns.

Titchener-Hooker, N.J.; Gritsis, D.; Olbrich, R.;Gardiner, S.A.M.; Mannweiler, K.; Fish, N.M.; andHoare, M. Integrated Process Design for Producingand Recovering Proteins from Inclusion Bodies.July–August 1991, p. 34.

Titchener-Hooker, N.J.; Sinclair, P.A.; Hoare, M.;Vranch, S.P.; Cottam, A.; and Turner, M.K. TheSpecifications of Static Seals for ContainedOperations: An Engineering Appraisal. October1993, p. 32.

Tolbert, William R., and Srigley, William R.Manufacture of Pharmacologically Active Proteinsby Mammalian Cell Culture. September 1987, p. 42.

Townsend, R. Reid. See Moellering, Bill J.Tran, An. See Rao, Patricia. Tung, Amar S.; Sample, Johanna vG.; Brown, Timothy

A.; Ray, Nitya G.; Hayman, Edward G.; andRunstadler Jr., Peter W. TPA Production throughMass Culturing of Chinese Hamster Ovary Cells.February 1988, p. 50.

Turner, M.K. See Titchener-Hooker, N.J.Tuthill, A.H. See Dillon, C.P.

Van Dorsselaer, Alain. See Monegier, Bertrand.Vasilevsky, M., and Cherry, C.W. Documentation

Requirements in the Biotechnology Industry.October 1990, p. 32.

Vaughn, James L, and Weiss, Stefan A. FormulatingMedia for the Culture of Insect Cells. February1991, p. 16.

Via III, John W. See Costa, Daniel W.Vercimak, Charmaine. Columnist. See Subject Index:

Documentation Basics Column.Vranch, S.P. See Titchener-Hooker, N.J.Vuilhorgne, Marc. See Monegier, Bertrand.

Wagner, Barbara H., and Drohan, William N. HIV inthe Laboratory: Minimizing the Risk of Exposure.July–August 1988, p. 26.

Wagner, Michael J. Depositing Organisms for PatentPurposes. July/August 1993, p. 26.

Walker, Mike. See Gavit, Patrick. Walthall, B.J. See Caple, M.V.Walton, Leslie. See Weaver, Kurt.Watson, Greg, and Quezada, Fernando.

Massachusetts’s Policy Environment. September1987, p. 66.

Weary, Marlys, and Pearson III, Frederick. AManufacturer’s Guide to Depyrogenation. April1988, p. 22.

Weaver, Kurt; Chen, David; Walton, Leslie; Elwell,Lynn; and Ray, Paul. Uridine PhosphorylasePurified from Total Crude Extracts of E. coli: UsingQ Sepharose and Radial-Flow Chromatography.July–August 1990, p. 25.

Wechsler, Jill. The Capitol Connection column. SeeSubject Index: Government Policies.

Weickmann, Joachim. See Gavit, Patrick. Weil, Stephen, and Amer, Gamal I. Selecting an

Engineering Firm: A Guide for BiotechnologyCompanies. March 1994, p. 38.

Weiner, Alan L. Developing Lipid-Based Vehicles forPeptide and Protein Drugs, Part I: Selection andAnalysis Issues. March 1990, p. 27.

Weiner, Alan L. Lipid-Based Vehicles for Peptide andProtein Drugs, Part II: Manufacturing Variables.April 1990, p. 16.

Weiss, Stefan. See Fike, Richard M.Weiss, Stefan. See Vaughn, James L.

6 BioPharm Index


Wendt, Denise. Professional Societies andAssociations. January 1994, p. 44.

Wert, Karen, and Furst, Allen. High-ResolutionElectrophoretic Separations of Megabase DNAMolecules. January 1989, p. 38.

Wheeler, Tim. See Gavit, Patrick. White, Elizabeth M. See Grun, Janet B.White, Elizabeth M.; Grun, Janet B.; Sun, Chong-Son;

and Sito, Alexander F. Process Validation for VirusRemoval and Inactivation. May 1991, p. 34.

White, R. Steven. See Dibner, Mark D.Whiteman, Mary. See Fenno, James.Wight, Hugh D. See Seely, Robert J.Williams, Allan. See Rao, Patricia. Williams, Bernard L., and Chew, Nancy J. “Ensuring

Parenteral Package Integrity” in Regulatory Affairs.April 1994, p. 22.

Williams, C.M. See Keathley, J.D.Williams, C.M. See Wyatt, D.E.Williams, Darwin R. An Overview of Test Method

Validation. November 1987, p. 34.Williams, Kevin L. See Berzofsky, Ronald Lee.Wilson, Brent L. Preventing Discrimination and

Harassment in the Workplace. March 1992, p. 38. Winter, Jennifer. Professional Societies and

Associations. January–February 1993, p. 46.Winter, Jennifer; Montgomery, S. Anne; and Carlson,

Karen. Biotechnology Resource Guide: Update ’93.April 1993, p. 38.

Wisher, Martin H. See Schiff, Leonard J.Wolber, Peter; Dosmar, Michael; and Banks, Jim. Cell

Harvesting Scale-Up: Parallel-Leaf Cross-FlowMicrofiltration Methods. June 1988, p. 38.

Wright, Peter B. See Lyttle, Matthew H.Wu-Pong, Susanna. Oligonucleotides: Opportunities

for Drug Therapy and Research. November 1994, p. 20.

Wyatt, D. See Keathley, J.D.Wyatt, D.E.; Keathley, J.D.; Williams, C.M.; and

Broce, R. Is There Life after Irradiation? Part 1:Inactivation of Biological Contaminants. June 1993,p. 34.

Wyden, Ron. Viewpoint: Backlog at the U.S. Patentand Trademark Office. June 1991, p. 20.

Wyrick, Michael L. See Grigonis, Jr., George J.

Young, Delano V.; Dobbels, Susan; King, Louise;Deer, Frank; and Gillies, Stephen D. InvertedMicrocarriers: Using Microencapsulation to GrowAnchorage-Dependent Cells in Suspension.November–December 1989, p. 34.

Young, Frank E. Viewpoint: RegulatingBiotechnology. September 1987, p. 24.

Young, Mark A. “The Public Financing Window,” inBusiness Matters. October 1991, p. 48.

Zakas, Dennis L., and Maffett, Stephanie K. Taking aBiotech Company Public. October 1994, p. 24.

Zavela, David A. See Brasker, John D.

SUBJECTS

Affinity LigandsSee Analytical Techniques.

Analytical TechniquesAn Analysis of Clearance Factor Measurements

Performed by Spiking Experiments. Thomas C.Hageman. July–August 1991, p. 39.

Biologically Active Peptides: Design, Synthesis, andUtilization. William V. Williams and David B.Weiner, Eds. Reviewed by Brian R. Shmaefsky.May 1993, p. 49.

Bioseparation and Purification of Proteins: AnAnalysis of Novel Techniques and InactivatingInfluences. Ajit Sadana and R.R. Raju. May 1990,p. 53.

Biotechnology Product Validation, Part 5: Selectionand Validation of Analytical Techniques. JohnMcEntire. June 1994, p. 68.

C-Terminal Modification Occurs in Tissue CultureProduced OKT3. Patricia Rao, Allan Williams,Alysia Baldwin-Ferro, Eileen Hanigan, DanielKroon, Mary Makowski, Eric Meyer, VanchaiNumsuwan, Ellen Rubin, and An Tran.November–December 1991, p. 38.

Carbohydrate Antigens. Per J. Garegg and Alf. A.Lindberg, Eds. Reviewed by Stuart W. Tanenbaum.October 1994, p. 54.

The Characterization of Transformed Cell Substrates.James Fenno, Janet Luczak, Alan Moore, JudyPoiley, Ronald Raineri, and Mary Whiteman.September 1988, p. 36.

Chemical Reagents for Protein Modification, 2d ed.Roger L. Lundblad. Reviewed by Alain Balland.November 1994, p. 55.

Chemistry of Protein Conjugation and Cross-Linking.Shan S. Wong. Reviewed by Richard M. Bauer.March 1994, p. 60.

Crystallization as a Separations Process. Allan S.Myerson and Ken Toyokura, Eds. Reviewed byStanley S. Grossel. October 1991, p. 54.

Determining Residual DNA Levels: Comparison ofHybridization with an Alternative Method. StevenR. Per, Catherine R. Aversa, Paul D. Johnston,Theresa L. Kopasz, and Alexander F. Sito.November–December 1993, p. 34.

Developing Lipid-Based Vehicles for Peptide andProtein Drugs, Part I: Selection and Analysis Issues.Alan L. Weiner. March 1990, p. 27.

DNA Probes in Infectious Disease Diagnosis. Ira G.Rosen. September 1987, p. 31.

DNA Sequencing Support Service: LiteratureCollection and Video Program. United StatesBiochemical. Reviewed by Margaret A. Lindorfer.March 1991, p. 32.

Electrophoretic Differences in a MAb Expressed inThree Media. Bill J. Moellering, John L. Tedesco,R. Reid Townsend, Mark R. Hardy, Randy W.Scott, and Christopher P. Prior. February 1990,p. 30.

Fermentation Kinetics and Modelling. C.G. Sinclairand B. Kristiansen. Reviewed by Robert Z.Maigetter and George A. Robertson. January 1990,p. 42.

Fibrous Protein Structure. John M. Squire and Peter J.Vibert, Eds. Reviewed by James W. Mitchell.July–August 1990, p. 44.

Frontiers in Bioprocessing II. Paul Todd, Subhas K.Sikdar, and Milan Bier, Eds. Reviewed by Robert D.Kiss. March 1993, p. 51.

Good Laboratory Practice Regulations. Vol. 38, Drugsand the Pharmaceutical Sciences. Allen F. Hirsch,Ed. Reviewed by Jagdish Parasrampuria. February1991, p. 45.

Homogeneity Analysis of a Nuclease Secreted by E.coli. Kirsten Biedermann and Bjarne RønfeldtNielsen. June 1990, p. 34.

Immobilized Affinity Ligand Techniques. Greg T.Hermanson, A. Krishna Mallia, and Paul K. Smith.

Reviewed by S. Subramanian. October 1994, p. 53.In Vitro Methods in Toxicology. G. Jolles and A.

Cordier, Eds. Reviewed by Brian R. Shmaefsky.January 1994, p. 58.

Large-Scale Automated DNA Synthesis. Matthew H.Lyttle, Ronald M. Cook, and Peter B. Wright.July–August 1988, p. 34.

Liposomes as Drug Delivery Systems, Part 2:Characterization. H. Talsma and D.J.A. Crommelin.November–December 1992, p. 38.

Manufacturing New-Generation Proteins, Part I: TheTechnology. P.M. Hammond, T. Atkinson, R.F.Sherwood, and M.D. Scawen. April 1991, p. 16.

Methods for Estimating Retroviral Burden. Judith A.Poiley, Sarah T. Bierley, Tove Hillesund, R. EarlNelson, Thomas M. Monticello, and Ronald Raineri.May 1994, p. 32.

Microalgae in the Pharmaceutical Industry. Paul W.Behrens and Jacques J. Delente. June 1991, p. 54.

Molecular Genetic Analysis of Populations: APractical Approach. A.R. Hoelzel, Ed. Reviewed byBrian R. Shmaefsky. January–February 1993, p. 53.

Particle Size Analysis in Pharmaceutics and OtherIndustries. Clive Washington. Reviewed by TarunK. Mandal. May 1994, p. 53.

PCR Protocols: A Guide to Methods and Applications.Michael A. Innis et al., Eds. Reviewed by MargaretA. Lindorfer. January–February 1992, p. 54.

Peptide Mapping, Part I. Fred E. Regnier. January1988, p. 19.

Peptide Mapping, Part II. Fred E. Regnier. February1988, p. 16.

Preserving Dry Biomaterials: The Water ReplacementHypothesis, Part 1. John H. Crowe, Lois M. Crowe,and John F. Carpenter. April 1993, p. 28.

Preserving Dry Biomaterials: The Water ReplacementHypothesis, Part 2. John H. Crowe, Lois M. Crowe,and John F. Carpenter. May 1993, p. 40.

Primary Structure Analysis of Recombinant Proteins.Stanley Stein. February 1989, p. 30.

Propagation of Human Immunodeficiency Virus inFlexible Tissue Culture Vessels. C. Sun and J.Chapman. April 1991, p. 34.

Protein Inactivation during Downstream Separation,Part I: The Processes. Ajit Sadana. April 1989,p. 14.

Protein Methods. Daniel M. Bollag and Stuart J.Edelstein. Reviewed by Yeldur P. Venkatesh.January 1994, p. 58.

Protein Predictor 2.0. Atlantic Software. Reviewed byScott Presnell. May 1993, p. 49.

Purification and Analysis of Recombinant Proteins.Volume 12, Bioprocess Technology Series. RamnathSeetharam and Satish K. Sharma, Eds. Reviewed byBrian R. Shmaefsky. May 1992, p. 42.

Recovery of Therapeutic-Grade Antibodies: Protein Aand Ion-Exchange Chromatography. Stephen A.Duffy, Bill J. Moellering, Garance M. Prior, KevinR. Doyle, and Christopher P. Prior. June 1989,p. 34.

RNA Editing: The Alteration of Protein CodingSequences of RNA. Rob Benne, Ed. Reviewed byLarry M. Allen. March 1994, p. 59.

RNA Processing: Part B, Specific Methods. Vol. 181,Methods in Enzymology. James E. Dahlberg andJohn N. Abelson, Eds. Reviewed by Pramod B.Mahajan. July–August 1991, p. 46.

Separating Clinical-Grade Chimeric Antibodies fromSerum-Derived Immunoglobulins. Bill J. Moelleringand Christopher P. Prior. January 1990, p. 34.

Sequence Analysis Primer. Michael Gribskov and John

BioPharm Index 7


Devereux, Eds. Reviewed by William A. Mehl.January–February 1993, p. 52.

Spectroscopy in the Biomedical Sciences. R. MichaelGendreau, Ed. Reviewed by Claud G. Cameron,Dale Owens, and Rafael E. Sarabia. September1988, p. 56.

Statistical Methodology in the PharmaceuticalSciences. Vol. 104, Statistics: Textbooks andMonographs. D.A. Berry, Ed. Reviewed by TarunK. Mandal. February 1991, p. 45.

Supercritical Fluid Engineering Science:Fundamentals and Applications. Erdogan Kiran andJoan F. Brennecke, Eds. Reviewed by Kenneth H.Brown. November 1994, p. 55.

Technical Descriptions. Vol. 1, Handbook ofImmunoblotting of Proteins. O.J. Bjerrum andN.H.H. Heegaard. Reviewed by Joseph A. Tami.January 1990, p. 42.

Technical Note: Calcium Alginate Hydrogel As aMatrix for Enteric Delivery of Nucleic Acids.Timothy J. Smith. April 1994, p. 54.

Technical Note: Heparin as a Nontoxic Displacer forAnion-Exchange Protein Displacement Systems.Joseph A. Gerstner and Steven M. Cramer.November–December 1992, p. 42.

Technical Note: Total Protein Analysis of SwabSamples for the Cleaning Validation of BioprocessEquipment. Mark A. Strege, John J. Dougherty, W.Richard Green, and Avinash L. Lagu. November1994, p. 40.

Technical Note: Validation of Endotoxin Removalfrom Parenteral Vial Closures. Ronald Berzofsky,Lee S. Scheible, and Kevin L. Williams. June 1994,p. 58.

Techniques in Biocompatibility Testing. Vol. 1. D.F.Williams, Ed. Reviewed by Umesh V. Banakar.May 1989, p. 44.

Thermodynamic Data for Biochemistry andBiotechnology. Hans-Jürgen Hinz, Ed. Reviewed byRobert F. Dream. February 1991, p. 46.

Updating USP Waters Monographs and Tests: PMA-Proposed Changes. Emil G. Ginev. September 1993,p. 52.

Use of the Limulus Amebocyte Lysate (LAL) Assay inLiving Cell Therapies. Gary C. du Moulin, John E.Price, Yuan-Jin Shen, and Michael E. Osband.March 1992, p. 32.

Using Mass Spectrometry to CharacterizeRecombinant Proteins. Bertrand Monegier, FrançoisFrédéric Clerc, Alain Van Dorsselaer, MarcVuilhorgne, Brian Green, and Terence Cartwright.November–December 1990, p. 26.

Animals in ResearchAlternatives to Animal Use in Research, Testing, and

Education. Office of Technology Assessment, U.S.Congress. Reviewed by Horst Kehl. January 1990,p. 47.

In Vitro Methods in Toxicology. G. Jolles and A.Cordier, Eds. Reviewed by Brian R. Shmaefsky.January 1994, p. 58.

“Research Ethics: Researchers and Animal RightsActivists, the Human Genome Project, Government-Industry Collaboration,” in The Capitol Connection.Jill Wechsler. June 1990, p. 26.

Antisense TechnologyAntisense Technology: Principles and Prospects for

Therapeutic Development. Linda A. Chrisey andJames W. Hawkins. June 1991, p. 36.

Oligonucleotide-Based Therapeutics. Michael I.

Sherman. September 1993, p. 38.Oligonucleotides: Opportunities for Drug Therapy and

Research. Susanna Wu-Pong. November 1994, p. 20.

Aseptic ProcessingAseptic Pharmaceutical Manufacturing: Technology

for the 1990s. W.P. Olson and M.J. Groves, Eds.Reviewed by Umesh V. Banakar. February 1988,p. 56.

Environmental Requirements for Clean Rooms. JohnY. Lee. February 1989, p. 42.

Personnel Issues in Aseptic Processing. John W.Levchuk and Anthony G. Lord. September 1989,p. 34.

AutomationAutomated Protein Microsequencing: Using an Amino

Acid Homopolymer as an Internal Standard. JamesBausch and Wasyl Sydor. May 1989, p. 40.

Automation of Biopharmaceutical PurificationProcesses. Tom C. Ransohoff, Marilee K. Murphy,and Howard L. Levine. March 1990, p. 20.

Batch Process Automation Applied to RecombinantFermentation Systems. John D. Brasker, Mark A.Smith, and David A. Zavela. November–December1991, p. 28.

Computer System Validation, Part I: Testing andVerification of Applications Software. Leonard J.Goren. November–December 1988, p. 28.

Draft Guidelines on Good Automated ManufacturingPractice: A Conference Report. Martin Rosser. April1994, p. 28.

Expert Systems in Bioprocessing. Kenneth P. Clappand Gregory J. Ruel. February 1991, p. 28.

Feeding Strategies for Enhanced HybridomaProductivity: Automated ConcentrateSupplementation. Richard Fike, James Kubiak, PaulPrice, and David Jayme. October 1993, p. 49.

A Gradient-Feed Process for E. coli Fermentations.B.R. Allen and G.W. Luli. November 1987, p. 38.

Granulation Technology for Bioproducts. Kiran L.Kadam, Ed. Reviewed by Guru V. Betageri. March1994, p. 59.

Immunoassay Automation: A Practical Guide. DanielW. Chan, Ed. Reviewed by Michael Molloy. May1994, p. 53.

Installation and Operational Qualification of PLCSystems. Roger Notarian. October 1993, p. 46.


Maximizing LIMS Results through Effective StrategicPlanning. Patrick Chassaigne. June 1992, p. 48.

Rapid Transit of Samples from Fermentor to Analyzer.Donald A. Burns. April 1988, p. 42.

Biocompatibility TestingSee Analytical Techniques.

BiopreservationAnother View of Trehalose for Drying and Stabilizing

Biological Materials. Harry Levine and LouiseSlade. May 1992, p. 36.

Freeze-Drying of Proteins, Part I: Process Design.Michael J. Pikal. September 1990, p. 18.

Freeze-Drying of Proteins, Part II: FormulationSelection. Michael J. Pikal. October 1990, p. 26.

Liposomes as Drug Delivery Systems, Part 3:Stabilization. H. Talsma and D.J.A. Crommelin.

March 1993, p. 40.Materials Science and the Production of Shelf-Stable

Biologicals. Felix Franks, Ross H.M. Hatley, andSheila F. Mathias. October 1991, p. 38.

Preserving Dry Biomaterials: The Water ReplacementHypothesis, Part 1. John H. Crowe, Lois M. Crowe,and John F. Carpenter. April 1993, p. 28.


Protein Stability and Stabilization through ProteinEngineering. Yoshiaki Nosoh and TakeshiSekiguchi. Reviewed by Umesh Banakar.January–February 1993, p. 53.

Stability of Protein Pharmaceuticals, Part A: Chemicaland Physical Pathways of Protein Degradation.Tim J. Ahern and Mark C. Manning, Eds. Reviewedby Yashoda V. Pramar. June 1993, p. 68.

Stability of Protein Pharmaceuticals, Part B: In VivoPathways of Degradation and Strategies for ProteinStabilization. Tim J. Ahern and Mark C. Manning,Eds. Reviewed by Yashoda V. Pramar. June 1993,p. 68.

Trehalose Drying: A Novel Replacement for Freeze-Drying. Bruce Roser. September 1991, p. 47.

Bioreactor DesignAirlift Bioreactors. M.Y. Chisti. Reviewed by Robert

S. Cherry. July–August 1991, p. 47.Airlift Bioreactors for Production of Monoclonal

Antibodies. G.P. Cortessis and C.M. Proby.November 1987, p. 30.

Animal Cell Bioreactors. Chester S. Ho and Daniel I.C.Wang, Eds. Reviewed by K. Jim Jem. July–August1991, p. 48.

Bioreactors in Biotechnology: A Practical Approach.A.H. Scragg, Ed. Reviewed by K. Jim Jem. October1992, p. 46.

Basic Bioreactor Design. Klaas van ‘t Riet andJohannes Tramper, Eds. Reviewed by Wayne P.Olson. January–February 1992, p. 53.

Bioprocess Technology: Kinetics and Reactors. AntonMoser. Reviewed by Stanley S. Grossel.July–August 1990, p. 41.

Bioreactor Design Fundamentals. Norton G.McDuffie. Reviewed by K. Jim Jem. July–August1992, p. 49.



Industrial-Scale Mammalian Cell Culture, Part I:Bioreactor Design Considerations. Kim L. Nelson.February 1988, p. 42.

Industrial-Scale Mammalian Cell Culture, Part II:Design and Scale-Up. Kim L. Nelson. March 1988,p. 34.

Material Selection for Components in a Pilot-PlantFermentation System. E. Grave. January 1988,p. 22.

Stainless Steels for Bioprocessing, Part 1: MaterialsSelection. C.P. Dillon, D.W. Rahoi, and A.H.Tuthill. April 1992, p. 38.

Stainless Steels for Bioprocessing, Part 2: Classes ofAlloys. C.P. Dillon, D.W. Rahoi, and A.H. Tuthill.May 1992, p. 32.

Stainless Steels for Bioprocessing, Part 3: CorrosionPhenomena. C.P. Dillon, D.W. Rahoi, and A.H.

8 BioPharm Index


Tuthill. June 1992, p. 40.Stainless Steels for Bioprocessing, Part 4:

Procurement, QA/QC. C.P. Dillon, D.W. Rahoi, andA.H. Tuthill. July–August 1992, p. 31.

TPA Production through Mass Culturing of ChineseHamster Ovary Cells. Amar S. Tung, Johanna vG.Sample, Timothy A. Brown, Nitya G. Ray, EdwardG. Hayman, and Peter W. Runstadler, Jr. February1988, p. 50.

BiosensorsApplied Biosensors. D.L. Wise, Ed. Reviewed by

Umesh V. Banakar. July–August 1990, p. 42.Bioinstrumentation and Biosensors. Donald L. Wise,

Ed. Reviewed by Umesh V. Banakar. April 1992, p. 50.

Biosensors. Elizabeth A.H. Hall. Reviewed by UmeshV. Banakar. July–August 1992, p. 48.

Biosensors and Chemical Sensors: OptimizingPerformance Through Polymeric Materials. PeterG. Edelman and Joseph Wang, Eds. Reviewed byRichard M. Bauer. October 1993, p. 58.

The Development and Potential Uses of Biosensors.Anuradha Athani and Umesh V. Banakar. January1990, p. 23.

Fluorescent Measurement of Biomass in MammalianCell Cultures. Gregory J. MacMichael, William B.Armiger, George F. Lee, and Richard J. Krause.May 1988, p. 48.


Separations Technology Outlook, Part I: TheChallenges of the Biopharmaceutical Industry.Nancy E. Pfund and Kathleen G. Charles.November 1987, p. 20.

Separations Technology Outlook, Part II: ImprovedRecovery and Greater Purity. Nancy E. Pfund andKathleen G. Charles. January 1988, p. 29.

BioseparationSee Separation and Purification.

Biotechnology BasicsA Revolution in Biotechnology. J.L. Marx, Ed.

Reviewed by S. Anne Montgomery. March 1990,p. 43.

An Introduction to Genetic Analysis, 4th ed. DavidSuzuki, Anthony Griffiths, Jeffrey Miller, andRichard Lewontin. Reviewed by Brian R.Shmaefsky. February 1991, p. 46.

Basic Biotechnology. J. Bu’Lock and B. Kristiansen,Eds. Reviewed by Umesh V. Banakar. June 1988,p. 50.

Biochemical Engineering and BiotechnologyHandbook, 2d ed. Bernard Atkinson and FerdaMavituna, Eds. Reviewed by Brian D. Kelley. May1992, p. 42.

Bioprocesses and Engineering. Vol. 40, Advances inBiochemical Engineering/Biotechnology. A.Fiechter, Ed. Reviewed by Richard M. Bauer.September 1990, p. 50.

Biotechnological Innovations in Health Care.Biotechnology by Open Learning Series. G.Turnock, Ed. Reviewed by Brian R. Shmaefsky.July–August 1992, p. 49.

Biotechnology from A to Z. William Bains. Reviewedby Steve Brown, October 1993, p. 57.

Biotechnology — Current Progress. Volume 1. Paul N.Cheremisinoff and Louise M. Ferrante, Eds.Reviewed by Harold B. Reisman. May 1992, p. 42.

Biotechnology: The Biological Principles. M.D.Trevan, S.A. Boffey, K.H. Goulding, and P.Stanberry. Reviewed by George A. Robertson.February 1989, p. 46.

The Biotechnology Directory 1990: Products,Companies, Research, and Organizations. J.Coombs and Y.R. Alston. Reviewed by S. AnneMontgomery. September 1990, p. 51.

The Biotechnology Directory 1994. J. Coombs andY.R. Alston. Reviewed by Denise Wendt. October1994, p. 54.

Current Research in Protein Chemistry: Techniques,Structure, and Function. Joseph J. Villafranca, Ed.Reviewed by Patrick L. Coleman. February 1991,p. 44.

Dictionary of Biotechnology, 2d ed. James Coombs,Ed. Reviewed by Jane Ganter. June 1993, p. 73.

Dictionary of Microbiology and Molecular Biology, 2ded. Paul Singleton and Diana Sainsbury. Reviewedby S. Anne Montgomery. March 1990, p. 45.

DNA Cloning: A Practical Approach, Vol. 3. D.M.Glover, Ed. Reviewed by Gregg Bogosian. October1988, p. 37.

Drug, Device, and Diagnostic Manufacturing: TheUltimate Resource Handbook. Carol DeSain.Reviewed by Edward S. Balkovic. July–August1992, p. 48.

EPA-Speak: Interpharm Glossary of EPA Acronymsand Regulatory Terms. Dean E. Snyder. Reviewedby Brian R. Shmaefsky. November 1994, p. 54.

Fundamentals of Biotechnology. P. Prave, U. Faust, W.Sittig, and D.A. Sukatsch, Eds. Reviewed by UmeshV. Banakar. September 1989, p. 47.

Fundamentals of Protein Biotechnology. Vol. 7,Bioprocess Technology Series. Stanley Stein, Ed.Reviewed by Brian R. Shmaefsky. July–August1991, p. 49.

Genetic Engineering Fundamentals: An Introductionto Principles and Applications. Karl Kammermeyerand Virginia L. Clark. Reviewed by DollyParasrampuria. April 1990, p. 44.

The Guild Handbook of Scientific Illustration. ElaineR.S. Hodges, Ed. Reviewed by Barbara A.Mickelson. March 1991, p. 30.

Infrastructure and Activities of Cells. C.K. Leach, Ed.Reviewed by Margaret A. Lindorfer. June 1993, p.74.


Molecular Cell Biology, 2d ed. James Darnell, HarveyLodish, and David Baltimore. Reviewed by Brian R.Shmaefsky. February 1991, p. 44.

The Language of Biotechnology: A Dictionary ofTerms. John M. Walker and Michael Cox. Reviewedby S. Anne Montgomery. March 1990, p. 45.

Perspectives in Biochemistry. Volume 2. Hans Neurath,Ed. Reviewed by Wesley E. Workman. July–August1992, p. 49.

Pharmaceutical Biotechnology: A Programmed Text.S. William Zito, Ed. Reviewed by Hemanshu S.Shah. January–February 1993, p. 52.

Pharmaceutical Biotechnology: Fundamentals andEssentials, 1st ed. Melvin E. Klegerman andMichael J. Groves, Eds. Reviewed by Ajay K.Banga. October 1993, p. 57.

Physiology of the Bacterial Cell: A MolecularApproach. Frederick C. Neidhardt, John L.Ingraham, and Moselio Schaechter. Reviewed byWilliam A. Mehl. February 1991, p. 41.

Recombinant DNA Technology: Concepts and

Biomedical Applications. Mark Steinberg et al.Reviewed by David Schoenhaut. July–August 1994,p. 51.

Upstream Processes: Equipment and Techniques. Vol.7, Advances in Biotechnological Processes.Avshalom Mizrahi, Ed. Reviewed by Stanley S.Grossel. January 1990, p. 43.

Validation for Device and Diagnostic Manufacturers,Part 1: Basic Principles. Carol DeSain andCharmaine Vercimak Sutton. October 1994, p. 46.

Yeast: A Practical Approach. I. Campbell and J.H.Duffus, Eds. Reviewed by Dana M. Summers.February 1991, p. 42.

Yeast: Biotechnology and Biocatalysis. Vol. 5,Bioprocess Technology Series. Hubert Verachtertand René De Mot, Eds. Reviewed by Brian D.Kelley. February 1991, p. 41.

Business Issues“Challenging Conventional Wisdom: Projecting

Biotech’s Future,” in Business Matters. G. StevenBurrill. November 1994, p. 48.

Selecting an Engineering Firm: A Guide forBiotechnology Companies. Stephen Weil andGamal I. Amer. March 1994, p. 38.

Barriers to Success: Hurdles in the BiotechnologyRace. John E. Bailey, Jr., Mark D. Dibner, and NoelP. Greis. March 1991, p. 16.

“Biotech in the ’80s and ’90s — What’s Different?” inBusiness Matters. G. Steven Burrill. March 1992,p. 46.

“Biotech’s Impact on the U.S. Drug Industry,” inBusiness Matters. G. Steven Burrill. June 1992,p. 62.

“Biotech Ups and Downs in the Public Market,” inBusiness Matters. G. Steven Burrill. May 1992,p. 47.

Biotechnology and Pharmaceuticals: MergingTogether. Mark D. Dibner and Jane T. Osterhaus.September 1987, p. 56.

Biotechnology in the United States and Japan: Who’son First? Mark D. Dibner and R. Steven White.February 1989, p. 22.

Biotechnology in the U.S. Pharmaceutical Industry.North Carolina Biotechnology Center. Reviewed byMark D. Dibner. July–August 1991, p. 48.

Biotechnology Resource Guide: Update ’93. JenniferWinter, S. Anne Montgomery, and Karen Carlson.April 1993, p. 38.

Chemical Engineering Economics. Donald E. Garrett.Reviewed by Stanley S. Grossel. March 1990, p. 42.

Cost-Estimating Factors for Biopharmaceutical ProcessEquipment. Donald S. Remer and Javier H. Idrovo.October 1990, p. 36.

“Drug Price Controls: A Changing Reality,” inRegulatory Affairs. Elizabeth R. Carder, Debra A.McCurdy, and Nancy J. Chew. May 1993, p. 18.

“Entrepreneurship and Innovation,” in BusinessMatters. G. Steven Burrill. July–August 1991, p. 42.

Expression Systems for Heterologous ProteinProduction. Margaret Habash Marino. July–August1989, p. 18.

FDA’s Small Business Assistance Program. Mark S.Roh. January–February 1992, p. 26.

Federal Bio-Technology Transfer Directory. RonaldA. Radar and Sally A. Young. Reviewed by JillWechsler. July–August 1994, p. 50.

“Getting Permission to Market in the U.S.,” inRegulatory Affairs. Nancy J. Chew. June 1992, p.22.

Going Public — Step by Step. Alan J. Bowers. October

BioPharm Index 9


1991, p. 44.Going Public — Why and When. Alan J. Bowers.

September 1991, p. 45.International Strategic Alliances. Maria-Luisa

Maccecchini. July–August 1991, p. 28.“Managing in a Recessionary Environment: Some

Tips,” in Business Matters. G. Steven Burrill. April1991, p. 37.

“The Mounting Battle over Drug Prices,” in TheCapitol Connection. Jill Wechsler. October 1990,p. 20.

Partnering and Investing. Andrew P. Kerr, Lynn C.Klotz, Charles R. Morris, and Robert Schatz. June1991, p. 50.

“Patents, Regulations, Orphans Affect BiopharmIndustry,” in The Capitol Connection. Jill Wechsler.May 1990, p. 20.

Prescription for Finding a Strategic Partner. Donald R.Keer. November 1994, p. 34.

Private Placement — A Viable Alternative to an IPO.Bart J. Colli, Debra Groisser, and Karen De Paola.April 1992, p. 43.

Protein Production from Animal Cells: The Role ofContract Manufacturers. Yves Fouron. June 1988,p. 34.

“The Public Financing Window,” in Business Matters.Mark A. Young. October 1991, p. 48.

“Reflections on 1989: Framing Events for the Year toCome,” in Regulatory Affairs. Nancy J. Chew andGail C. Corrado. January 1990, p. 14.

“Regulations as Business Assets,” in RegulatoryAffairs. Nancy J. Chew. May 1990, p. 14.


Scientists as Entrepreneurs: OrganizationalPerformance in Scientist-Started New Ventures.Karel J. Samson. Reviewed by Thomas A. Smith.July–August 1991, p. 46.

The Scope of Patent Protection for PhysiologicallyImportant Proteins and Peptides. Michael B. Farberand Harris F. Brotman. April 1990, p. 22.

Taking a Biotech Company Public. Dennis L. Zakasand Stephanie K. Maffett. October 1994, p. 24.

Thinking Outside the Lines: Selecting a ContractResearch Agency. Christopher Ball.November–December 1993, p. 42.

Thinking Outside the Lines, Part 2: Working with aContract Research Agency. Christopher Ball. May1994, p. 40.

To Renovate or Build New: Guidelines for EvaluatingConstruction Alternatives. Donald Robins andRobert Del Ciello. January 1988, p. 34.

“Unexpected Boom in Equity Financing,” in BusinessMatters. G. Steven Burrill. April 1993, p. 50.

U.S. Biotechnology Resource Guide: Who Wants YourBusiness and What Will They Do to Get It? S. AnneMontgomery. January 1991, p. 16.

Using Other People’s Technology (OPT). Kenneth A.Kovaly. June 1990, p. 44.

“The Vaccines of Biotechnology: New Interest in OldRegulations,” in Regulatory Affairs. Nancy J. Chewand Gail C. Corrado. June 1989, p. 24.

Viewpoint: Backlog at the U.S. Patent and TrademarkOffice. Ron Wyden. June 1991, p. 20.

Viewpoint: Biopharmaceutical Manufacturing and theLocal Community — Education as the Key toHarmony. Wes Ervin. June 1990, p. 14.

Viewpoint: Biotechnology Bedfellows — MakingStrategic Partnerships Work. Richard L. Casey.

November–December 1989, p. 18.Viewpoint: Biotechnology in the ’90s. William E.

Small. May 1992, p. 17.Viewpoint: Corporate Partnering — One Company’s

Perspective. Steven C. Mendell. June 1988, p. 16.Viewpoint: Engineering the Cell-System Interface.

Robert S. Cherry. July–August 1988, p. 14.Viewpoint: The Great BioSeparations Debate —

Sound and Fury, Signifying . . . ? Nancy E. Pfund.May 1994, p. 16.

Viewpoint: Harmony Fellowships — Fostering theInternational Growth of Biotechnology. Ronald E.Cape. November 1987, p. 14.

Viewpoint: Managing Organizational Growth. RobertJ. Beckman. January–February 1993, p. 20.

Viewpoint: Opportunistic Opposition toBiotechnology. Burt D. Ensley. March 1993, p. 20.

Viewpoint: Quality Auditing as a Tool — IncreaseEfficiency and Reduce Costs. Robert N. Borghese.October 1990, p. 14.

Viewpoint: A Question of Balance — Strategies forGrowth in a Science-Based Industry. NormanCarey. January 1990, p. 12.

“When an Invention Becomes a Product,” inRegulatory Affairs. Nancy J. Chew.November–December 1991, p. 14.

Business Matters Columns“The Basics of Business Savvy: Management,

Strategy, and Technology.” G. Steven Burrill.March 1988, p. 18.

“Biotech ’94: Finding the Balance.” G. Steven Burrill.September 1993, p. 55.

“Biotech in the ’80s and ’90s — What’s Different?” G.Steven Burrill. March 1992, p. 46.

“Biotech Ups and Downs in the Public Market.” G.Steven Burrill. May 1992, p. 47.

“Biotech’s Impact on the U.S. Drug Industry.” G.Steven Burrill. June 1992, p. 62.

“The Biotechnology Industry: 1988 in Review.” G.Steven Burrill. January 1989, p. 14.

“The Biotechnology Industry: A First QuarterSnapshot.” G. Steven Burrill. May 1988, p. 20.

“The Biotechnology Industry: A Midyear Snapshot.”G. Steven Burrill. July–August 1988, p. 17.

“The Biotechnology Industry: A Midyear Snapshot.”G. Steven Burrill. July–August 1989, p. 12.

“The Biotechnology Industry: A Midyear StatusReport.” G. Steven Burrill. September 1990, p. 44.

“Biotechnology ’91: Adapting to a ChangingEnvironment.” G. Steven Burrill.November–December 1990, p. 18.

“Biotechnology Financing: Strategies after the‘Crash.’” G. Steven Burrill. April 1988, p. 14.

“Biotechnology Product Pricing: Issues, Concerns, andStrategies.” G. Steven Burrill. June 1989, p. 12.

“Biotechnology’s Promise and Challenge: Today’sPatent and Regulatory Environments.” G. StevenBurrill. September 1988, p. 22.

“Challenging Conventional Wisdom: ProjectingBiotech’s Future.” G. Steven Burrill. November1994, p. 48.

“Emerging Issues for Biopharmaceutical Companies.”G. Steven Burrill. October 1990, p. 43.

“Emerging Trends: 1994 First Quarter Update.” G.Steven Burrill. June 1994, p. 22.

“Entrepreneurship and Innovation.” G. Steven Burrill,July–August 1991, p. 42.

“Establishing a Competitive Advantage.” G. StevenBurrill. June 1988, p. 19.

“The Genentech-Roche Partnership: Responses and

Repercussions.” G. Steven Burrill. May 1990, p. 62.“Health Care Reform and Industry Response.” G.

Steven Burrill. June 1993, p. 54.“Health Care Reforms and Biopharmaceuticals.” G.

Steven Burrill. November–December 1992, p. 46.“Managing in a Recessionary Environment: Some

Tips.” G. Steven Burrill. April 1991, p. 37.“Manufacturing in Support of Business Strategy.” G.

Steven Burrill. February 1989, p. 14.“The 1990s: Biotechnology’s Decade of Truth.” G.

Steven Burrill. November–December 1989, p. 52.“Pharmacoeconomics and Health Care Reform.” Kent

Thompson and G. Steven Burrill. January 1994, p.50.

“Playing the Uncertainty Game.” G. Steven Burrill.May 1989, p. 14.

“Promise to Reality.” G. Steven Burrill.November–December 1991, p. 52.

“The Public Financing Window.” Mark A. Young.October 1991, p. 48.

“Reimbursement and Value Pricing.” G. Steven Burrilland Kent Thompson. February 1991, p. 36.

“Small-Company Partnering Tactics.” G. StevenBurrill. September 1994, p. 49.

“Strategic Alliances, Foreign Investments: MeetingU.S. Biotechnology Financial, ProductDevelopment Needs.” G. Steven Burrill. February1990, p. 45.

“Toward a National Biotechnology Policy.” G. StevenBurrill and Kenneth B. Lee. April 1990, p. 37.

“Unexpected Boom in Equity Financing.” G. StevenBurrill. April 1993, p. 50.

“Vertical Integration: Dream or Pipe Dream?” G.Steven Burrill. October 1988, p. 16.

“Virtual Integration: A 1990s Paradigm Switch.” G.Steven Burrill. April 1994, p. 56.

“Washington’s Biotechnology Agenda.” G. StevenBurrill. September 1989, p. 12.

“Where’s Industry Going in ’89?”G. Steven Burrill.March 1989, p. 18.

CANDAs“Can-Do Marketing Applications,” in Regulatory

Affairs. Nancy J. Chew. March 1993, p. 22.

Cell DisruptionSee Downstream Processing.

Cell Formulation and ViabilityBiotechnology Product Validation, Part 8:

Chromatography Media and Column Qualification.Anne R. Barry and Robert Chojnacki. November1994, p. 43.

Handbook of Microbiological Media. Ronald M. Atlas.Reviewed by Brian R. Shmaefsky. October 1994, p.53.

Cell Growth and ViabilityAspergillus: Biology and Industrial Applications. J.W.

Bennett and M.A. Klich, Eds. Reviewed by Brian R.Shmaefsky. November–December 1993, p. 47.


Bovine Somatotropin Production: Selecting the BestHost-Vector System. James F. Kane and GreggBogosian. November 1987, p. 26.

Continuous Flow Electrophoresis: Resolving Real andApparent Heterogeneity. Rizwan Sharnez and David

10 BioPharm Index


W. Sammons. January 1989, p. 54.Electrophoretic Differences in a MAb Expressed in

Three Media. Bill J. Moellering, John L. Tedesco,R. Reid Townsend, Mark R. Hardy, Randy W.Scott, and Christopher P. Prior. February 1990,p. 30.


Formulating Media for the Culture of Insect Cells.James L. Vaughn and Stefan A. Weiss. February1991, p. 16.

Handbook of Microbiological Media. Ronald M. Atlas.Reviewed by Brian R. Shmaefsky. October 1994, p.53.

Hybridoma Growth and Monoclonal AntibodyProduction in Protein-Free Hybridoma Medium.Richard M. Fike, Jeffrey L. Pfohl, David A. Epstein,David W. Jayme, and Stefan Weiss. March 1991,p. 26.

In Vitro Cultivation of Microorganisms. T.G.Cartledge, et al. Reviewed by Surj Sengha.November–December 1993, p. 48.

Is There Life after Irradiation? Part 1: Inactivation ofBiological Contaminants. D.E. Wyatt, J.D.Keathley, C.M. Williams, and R. Broce. June 1993,p. 34.

Is There Life after Irradiation? Part 2: Gamma-Irradiated FBS in Cell Culture. J.D. Keathley, D.E.Wyatt, C.M. Williams, R. Festen, and C. Maben.July–August 1993, p. 46.

Methods of Hybridoma Formation. A.H. Bartel and Y.Hirshant, Eds. Reviewed by Umesh V. Banakar.April 1988, p. 49.

Performance Characteristics of Polysulfone andCellulose Membranes for the Ultrafiltration ofBiological Process Streams. Peter F. Levy and JohnJ. Sheehan. April 1991, p. 24.

Production of Biologicals from Animal Cells inCulture. R.E. Spier, J.B. Griffiths, and B. Meignier,Eds. Reviewed by K. Jim Jem. May 1992, p. 53.

Propagation of Human Immunodeficiency Virus inFlexible Tissue Culture Vessels. C. Sun and J.Chapman. April 1991, p. 34.

Quality Assurance of Tissue Culture Media Used in theBiotechnology Industry. Roger W. Johnson.February 1990, p. 40.

Technical Note: A Dual Formulation Serum-FreeMedia System. M.V. Caple, T.R. Fletcher, W.J.Owens, S. Harada, T.J. Murphy, and B.J. Walthall.June 1992, p. 52.

Technical Note: An Irreversible Serine ProteaseInhibitor. Gilbert R. Mintz. March 1993, p. 34.

Use of Porous Microcarriers in Agitated Cultures. E.Adema, D. Shnek, F. Cahn, and A.J. Sinskey.July–August 1990, p. 20.

Viewpoint: Serum Substitutes — Is There a Solution?Margaret D. Rosa. March 1989, p. 16.

Cell HarvestingBatch Process Automation Applied to Recombinant

Fermentation Systems. John D. Brasker, Mark A.Smith, and David A. Zavela. November–December1991, p. 28.

Cell Harvesting Scale-Up: Parallel-Leaf Cross-FlowMicrofiltration Methods. Peter Wolber, MichaelDosmar, and Jim Banks. June 1988, p. 38.

Facilities for Large-Scale Protein Purification andIsolation. Robert J. Giorgio. May 1988, p. 38.

Cell Line CharacterizationATCC Quality Control Methods for Cell Lines. 2d ed.

American Type Culture Collection. Reviewed byEdward S. Balkovic. April 1993, p. 53.


Continuous Flow Electrophoresis: Resolving Real andApparent Heterogeneity. Rizwan Sharnez and DavidW. Sammons. January 1989, p. 54.


Protein Immobilization: Fundamentals andApplications. Vol. 14, Bioprocess TechnologySeries. Richard F. Taylor, Ed. Reviewed by PatrickL. Coleman. July–August 1992, p. 48.

“Validating Products Derived from Continuous CellLines,” in Regulatory Affairs. Martha J. Carter andRichard A. Scotland. November–December 1989,p. 24.

CentrifugationSee Downstream Processing.

ChromatographyAnalytical Biotechnology: Capillary Electrophoresis

and Chromatography. ACS Symposium Series 434.Csaba Horváth and John G. Nikelly, Eds. Reviewedby Brian R. Shmaefsky. January–February 1992,p. 55.


Biotechnological Applications and Methods. Vol. 29,Advances in Chromatography. J.C. Giddings, E.Grushka, and P.R. Brown, Eds. Reviewed by JohnF. Fitzloff. January 1991, p. 49.

Biotechnology Product Validation, Part 3:Chromatography Cleaning Validation. Niklas Adnerand Gail Sofer. April 1994, p. 44.

Biotechnology Product Validation, Part 7: Validationof Chromatography Resin Useful Life. Robert J.Seely, Hugh D. Wight, Holly H. Fry, Scott R.Rudge, and Geoffery F. Slaff. September 1994, p.41.

Biotechnology Product Validation, Part 8:Chromatography Media and Column Qualification.Anne R. Barry and Robert Chojnacki. November1994, p. 43.

Chemical Disinfection of Chromatographic Resins,Part 1: Preliminary Studies and Microbial Kinetics.Alois Jungbauer and Hans P. Lettner. June 1994, p.46.

Chemical Sanitization in Process Chromatography,Part 2: In Situ Treatment of Packed Columns andLong-Term Stability of Resins. A. Jungbauer, H.P.Lettner, L. Guerrier, and E. Boschetti. July–August1994, p. 37.

Chiral Separations by Liquid Chromatography. ACSSymposium Series #471. Satinder Ahuja, Ed.Reviewed by Kenneth H. Brown. July–August1992, p. 50.

Chromatographic Retention Indices: An Aid toIdentification of Organic Compounds. VeraPacakova and Ladislav Feltl. Reviewed byMohammad Khalid. March 1994, p. 60.

Determination of Leakage Products fromChromatographic Media Aimed for ProteinPurification. Bo-Lennart Johansson. April 1992,p. 34.



High Performance Liquid Chromatography inBiotechnology. William S. Hancock, Ed. Reviewedby Avinash L. Lagu. July–August 1991, p. 50.

High Performance Liquid Chromatography, 2d ed.Sandie Lindsay. Reviewed by Brian R. Shmaefsky.June 1993, p. 72.

Industrial-Scale Downstream Processing ofBiotechnology Products. David Naveh. May 1990,p. 28.


Peptide Mapping, Part I. Fred E. Regnier. January1988, p. 19.

Peptide Mapping, Part II. Fred E. Regnier. February1988, p. 16.

Peristaltic Pumps in Low-Pressure LC Systems. PeterG. Brown. March 1988, p. 46.

Process Chromatography: A Practical Guide. G.K.Sofer and L.E. Nystrom, Eds. Reviewed by StanleyS. Grossel. January 1991, p. 51.

Production-Scale Radial Flow Chromatography. VinitSaxena, K. Subramanian, Sanjeev Saxena, andMichael Dunn. March 1989, p. 46.


Protein Purification Using Affinity Ligands Deducedfrom Peptide Libraries. George A. Baumbach andDavid J. Hammond. May 1992, p. 24.

Protein Purification: Principles, High ResolutionMethods, and Applications. J.-C. Janson and LarsRydén, Eds. Reviewed by S. Subramanian. February1991, p. 42.




Thin Layer Chromatography: An Introduction. KarinBauer, Leo Gros, and Werner Sauer. Reviewed byDamon S. Anthony. October 1993, p. 59.

Uridine Phosphorylase Purified from Total CrudeExtracts of E. coli: Using Q Sepharose and Radial-Flow Chromatography. Kurt Weaver, David Chen,Leslie Walton, Lynn Elwell, and Paul Ray.July–August 1990, p. 25.

Clean-in-Place SystemsSee Utility Design.

Clean RoomsSee Controlled Environments.

BioPharm Index 11


Clinical Trials“Clinical Trials for In Vitro Diagnostics, Part 1,” in

Regulatory Affairs. Martha A. Feldman and NancyJ. Chew. November–December 1992, p. 16.

“Clinical Trials for In Vitro Diagnostics, Part 2,” inRegulatory Affairs. Martha A. Feldman and NancyJ. Chew. January–February 1993, p. 24.

The Design and Analysis of Sequential Clinical Trials,2d ed. John Whitehead. Reviewed by Damon S.Anthony. November–December 1993, p. 47.

Managing the Clinical Drug Development Process.David M. Cocchetto and Ronald V. Nardi, Eds.Reviewed by Frank Pokrop. January–February1993, p. 53.

New Drug Approval Process, 2d ed. Richard A.Guarino. Reviewed by William E. Heary. October1993, p. 60.

Patient Recruitment in Clinical Trials. Bert Spilker andJoyce A. Cramer. Reviewed by Jeanna L. Welborn.January 1994, p. 58.

Computers: Hardware/SoftwareA Practical Approach to the Analysis of 2-D Gels.

Martha L. Booz. January 1989, p. 44.Automation of Biopharmaceutical Purification

Processes. Tom C. Ransohoff, Marilee K. Murphy,and Howard L. Levine. March 1990, p. 20.


Computer System Validation — Staying Current:Introduction. K.G. Chapman and J.R. Harris(Pharmaceutical Manufacturers Association). May1989, p. 30.

Computer System Validation — Staying Current:Software Development Testing Strategies. E.J.Subak, Jr. (Pharmaceutical ManufacturersAssociation). September 1989, p. 24.


Computer System Validation, Part II: EvaluatingVendor Software. Leonard J. Goren. February 1989,p. 38.

Computer System Validation: Auditing ComputerSystems for Quality. PhRMA Computer SystemsValidation Committee, George J. Grigonis, Jr., andMichael L Wyrick, principal authors. September1994, p. 22.

Computer System Validation: Change Control. JamesAgalloco (Pharmaceutical ManufacturersAssociation). May 1990, p. 38.

Computer System Validation: InstallationQualification. J.S. Alford and F.L. Cline(Pharmaceutical Manufacturers Association).September 1990, p. 32.

Computer Validation Compliance: A QualityAssurance Perspective. Mary Ellen Double andMaryann McKendry. Reviewed by Brian E.McCole. October 1994, p. 54.

Computers in Fermentation Technology. Vol. 25,Progress in Industrial Microbiology. M.E. Bushell,Ed. Reviewed by Harold B. Reisman. April 1990,p. 44.

Configurable Software Validation for Batch Processes.Daniel W. Costa and John W. Via III. May 1991,p. 40.


Maximizing LIMS Results through Effective Strategic

Planning. Patrick Chassaigne. June 1992, p. 48.Protein Predictor 2.0. Atlantic Software. Reviewed by

Scott Presnell. May 1993, p. 49.Quantitative 2-D Electrophoresis and Computer-

Assisted Analysis. Paul J. Collins and Marc R.Krauss. January 1989, p. 50.

The Gene Construction Kit. (software) Textco.Reviewed by David C. Hagen. April 1992, p. 50.

Contamination Control“Ensuring Parenteral Package Integrity” in Regulatory

Affairs. Bernard L. Williams and Nancy J. Chew.April 1994, p. 22.


A Manufacturer’s Guide to Depyrogenation. MarlysWeary and Frederick Pearson III. April 1988, p. 22.


Biotechnology Product Validation, Part 6: IsolatorTechnology Applications. James E. Akers.July–August 1994, p. 43.



Clearance of Adventitious Virus During Bovine-Albumin Manufacture. Michael O. Budnick, ToddA. Cosenza, and John Black. October 1994, p. 32.

Controlling Contamination in Bioprocessing. CasimirA. Perkowski. September 1987, p. 62.


Is There Life after Irradiation? Part 1: Inactivation ofBiological Contaminants. D.E. Wyatt, J.D.Keathley, C.M. Williams, and R. Broce. June 1993,p. 34.

Is There Life after Irradiation? Part 2: Gamma-Irradiated FBS in Cell Culture. J.D. Keathley, D.Wyatt, C.M. Williams, R. Festen, and C. Maben.July/August 1993, p. 46.

Modular Design and Construction, Part 1: Installationand Maintenance. Scott E. Mackler. October 1992,p. 40.

Parenteral Quality Control: Sterility, Pyrogen,Particulate and Package Integrity Testing, 2d ed.Michael J. Akers. Reviewed by Carol DeSain.July–August 1994, p. 50.

Quality Assurance of Cell Cultures. Roger W. Johnson.January 1988, p. 43.



Sizing Clean-Steam Generators. Dan Adams.November–December 1988, p. 36.

The Specifications of Static Seals for ContainedOperations: An Engineering Appraisal. N.J.Titchener-Hooker, P.A. Sinclair, M. Hoare, S.P.

Vranch, A. Cottam, and M.K. Turner. October 1993,p. 32.





Ultraviolet Disinfection in Biotechnology: Myth versusPractice. Robert Janoschek and Gary C. du Moulin.January 1994, p. 24.

Viewpoint: Cell Culture Standardization. Gerard J.McGarrity. May 1988, p. 14.


Controlled EnvironmentsASTM Standards on Materials and Environmental

Microbiology, 2d ed. and ASTM Standards forCleanrooms, 1st ed. ASTM. Reviewed by TimothyWagner and Roger Notarian. November 1994, p. 56.

Biotechnology Facility Requirements, Part I: Facilityand Systems Design. Donald Hill and MichaelBeatrice. October 1989, p. 20.


Clean Room Management. Anne Marie Dixon.October 1988, p. 28.


Environmental Requirements for Clean Rooms. JohnY. Lee. February 1989, p. 42.

An HVAC Primer for Biopharmaceutical Facilities. S.Louis Kelter. May 1988, p. 30.

HVAC Systems for Biopharmaceutical ManufacturingPlants. Manuel A. del Valle. April 1989, p. 26.

Modular Design and Construction, Part 1: Installationand Maintenance. Scott E. Mackler. October 1992,p. 40.

Ultraviolet Disinfection in Biotechnology: Myth versusPractice. Robert Janoschek and Gary C. du Moulin.January 1994, p. 24.

DepyrogenationA Manufacturer’s Guide to Depyrogenation. Marlys

Weary and Frederick Pearson III. April 1988, p. 22.Recirculating Isoelectric Focusing: A System for

Protein Separations. Robert Kosecki. June 1988,p. 28.


Diagnostics“Clinical Trials for In Vitro Diagnostics, Part 1,” in

Regulatory Affairs. Martha A. Feldman and NancyJ. Chew. November–December 1992, p. 16.

“Clinical Trials for In Vitro Diagnostics, Part 2,” inRegulatory Affairs. Martha A. Feldman and NancyJ. Chew. January–February 1993, p. 24.

12 BioPharm Index


DNA Probes in Infectious Disease Diagnosis. Ira G.Rosen. September 1987, p. 31.

Monoclonal Antibodies in Cancer Therapy: ThePresent and the Future. Jeffrey Schlom. September1988, p. 44.

Monoclonal Antibodies: Production and Application.Vol. 11, Advances in Biotechnological Processes.Avshalom Mizrahi, Ed. Reviewed by Arthur Kunz.January 1990, p. 49.

“New HCFA Regs Would Burden Labs, Set Up TradeBarriers,” in Special Report. Nancy J. Chew.September 1990, p. 49.

“New Rules and Regs Rain on IVD Parade,” inRegulatory Affairs. Rosanne M. Savol and Nancy J.Chew. October 1992, p. 16.

Pharmaceutical Dosage Forms: ParenteralMedications, Vol. 1. 2d. ed. Kenneth E. Avis,Herbert A. Lieberman, and Leon Lachman, Eds.Reviewed by Sandeep Nema. October 1992, p. 45.

“Product Development and Registration, Part V: InVitro Diagnostic Products,” in Regulatory Affairs.Rosanne Savol. September 1988, p. 28.

Ultrasonics: Principles and Biomedical Applications.Pradeepkumar Sanghvi and Umesh V. Banakar.September 1991, p. 32.

DNA Assay MethodsSee Analytical Techniques.

DNA ProbesSee Analytical Techniques.

DNA SynthesisExpression Systems and Processes for rDNA Products.

Randolph T. Hatch, Charles Goochee, AntonioMoreira, and Yair Alroy, Eds. Reviewed by SurjSengha. October 1993, p. 59.


Oligonucleotide-Based Therapeutics. Michael I.Sherman. September 1993, p. 38.

Oligonucleotides and Analogues: A PracticalApproach. F. Eckstein, Ed. Reviewed by StanleyStein. October 1993, p. 60.

Oligonucleotides: Opportunities for Drug Therapy andResearch. Susanna Wu-Pong. November 1994, p.20.


Synthesis and Applications of DNA and RNA. S.A.Narang, Ed. Reviewed by Umesh V. Banakar. June1988, p. 49.

Documentation Basics Columns“Accountability and Traceability.” Carol DeSain and

Charmaine Vercimak. November–December 1993,p. 28.

“Clinical Data Collection Documents.” Carol DeSainand Charmaine Vercimak. October 1993, p. 26.

“Clinical Good Practice Documents.” Carol DeSainand Charmaine Vercimak. July/August 1993, p. 20.

“Clinical Protocols and Clinical SOPs.” Carol DeSainand Charmaine Vercimak. September 1993, p. 32.

“Designing GMP and Facility Qualification MasterProtocols.” Carol DeSain. April 1992, p. 18.

“Equipment and Utility System Validation Protocols.”Carol DeSain. May 1992, p. 21.

“Equipment Installation and Identification.” Carol

DeSain. January–February 1992, p. 23. “Equipment Monitoring, Repair, Preventive

Maintenance.” Carol DeSain. March 1992, p. 20. “Lot Numbers.” Carol DeSain. September 1991, p. 26.“Master Method Validation Protocols,” in

Documentation Basics. Carol DeSain. June 1992,p. 30.

“The Master Plan.” Carol DeSain and CharmaineVercimak. June 1993, p. 27.

“Master Production Batch Records.” Carol DeSain.November–December 1991, p. 20.

“Part Number Specifications.” Carol DeSain.July–August 1991, p. 24.

“Part Numbers.” Carol DeSain. June 1991, p. 28.“Process Validation Protocols.” Carol DeSain.

July–August 1992, p. 22.“Standard Operating Procedures and Data Collection

Forms.” Carol DeSain. October 1991, p. 22.

Downstream Processing“Validating Products Derived from Continuous Cell

Lines,” in Regulatory Affairs. Martha J. Carter andRichard A. Scotland. November–December 1989,p. 24.

Affinity Membranes: Their Chemistry andPerformance in Adsorptive Separation Processes.Elias Klein. Reviewed by Bhavender P. Sharma.July–August 1991, p. 50.



Bioseparation Steps for Proteins and Other BiologicalProducts, Part 1: Cell Disruption. Ajit Sadana.March 1994, p. 26.

Bioseparation Steps in Processing Proteins and OtherBiological Products, Part 2: Initial Fractionation.Ajit Sadana. April 1994, p. 34.

Bioseparations: Downstream Processing forBiotechnology. P.A. Belter, E.L. Cussler, and W.-S.Hu. Reviewed by Umesh V. Banakar. January 1990,p. 44.


Clean-Water Permeability As a Determinant ofCleaning Efficacy in Tangential-Flow FiltrationSystems. Stephen L. Michaels. October 1994, p. 38.

Determination of Leakage Products fromChromatographic Media Aimed for ProteinPurification. Bo-Lennart Johansson. April 1992, p.34.

The Development and Potential Uses of Biosensors.Anuradha Athani and Umesh V. Banakar. January1990, p. 23.

Downstream Processes: Equipment and Techniques.Vol. 8, Advances in Biotechnological Processes.Avshalom Mizrahi, Ed. Reviewed by Stanley S.Grossel. March 1990, p. 42.

Downstream Processing and Bioseparation: Recoveryand Purification of Biological Products. ACSSymposium Series #419. Jean-François P. Hamel,Jean B. Hunter, and Subhas K. Sikdar, Eds.Reviewed by Brian D. Kelley. February 1991, p. 40.

Extractive Bioconversions. Bo Mattiasson and OlleHolst, Eds. Reviewed by Stanley S. Grossel. March1993, p. 51.

Facilities for Large-Scale Protein Purification and

Isolation. Robert J. Giorgio. May 1988, p. 38.Genetically Engineered Proteins and Enzymes from

Yeast: Production Control. Alan Wiseman, Ed.Reviewed by Dave Clark. October 1992, p. 46.

Granulation Technology for Bioproducts. Kiran L.Kadam, Ed. Reviewed by Guru V. Betageri. March1994, p. 59.


Installation of a Non–Steam-in-Place Disk-StackCentrifuge for Biological Applications. M.M.Meagher. September 1994, p. 32.

Lipid-Based Vehicles for Peptide and Protein Drugs,Part II: Manufacturing Variables. Alan L. Weiner.April 1990, p. 16.


Methods in Protein Sequence Analysis. B. Wittmann-Liebold, Ed. Reviewed by Thomas S. Vedvick.January 1991, p. 50.

Methods Used to Validate Microporous Membranesfor the Removal of Mycoplasma. Kerry L. Rocheand Richard V. Levy. April 1992, p. 22.

New Role for Pilot Plants in Product Development.Robert Fahrner. April 1993, p. 34.



Protein Inactivation during Downstream Separation,Part II: The Parameters. Ajit Sadana. May 1989,p. 20.

Protein Inclusion Body Formation and Purification.Joanna K. Krueger, Matthew H. Kulke, C. Schutt,and Jeff Stock. March 1989, p. 40.

Protein Purification: From Molecular Mechanisms toLarge-Scale Processes. Vol. 427, ACS SymposiumSeries. Michael R. Ladisch, Richard C. Wilson,Chih-duen C. Painton, and Stuart E. Builder, Eds.Reviewed by Louis C. Smith. July–August 1991,p. 46.

Protein Stability and Stabilization through ProteinEngineering. Yoshiaki Nosoh and TakeshiSekiguchi. Reviewed by Umesh Banakar.January–February 1993, p. 53.


Recombinant DNA Proteins: Scale-Up Strategies forPurification. David Naveh. September 1987, p. 34.

Recombinant DNA Technology and Applications. AlesProkop, Rakesh K. Bajpai, and Chester S. Ho, Eds.Reviewed by Brian D. Kelley. April 1992, p. 50.

Removing Specific Cell Culture Contaminants in aMAb Purification Process. Lewis S. Hanna, PerlaPine, Gary Reuzinsky, Somesh Nigam, and DanielR. Omstead. October 1991, p. 33.

Scale-Up and Validation of Sedimentation Centrifuges,Part 1: Scale-Up. J.T. Mahar. September 1993, p.42.

Scale-Up and Validation of Sedimentation Centrifuges,Part 2: Validation. J.T. Mahar. October 1993, p. 38.

Separations for Biotechnology. M.S. Verrall and M.J.Hudson, Eds. Reviewed by Arthur Kunz. October1989, p. 50.


Stability of Protein Pharmaceuticals, Part B: In Vivo

BioPharm Index 13


Pathways of Degradation and Strategies for ProteinStabilization. Tim J. Ahern and Mark C. Manning,Eds. Reviewed by Yashoda V. Pramar. June 1993,p. 68.



Viewpoint: At the End of the Beginning. Elmer L.Gaden, Jr. September 1988, p. 18.

Viral Removal/Inactivation by Purification ofBiopharmaceuticals. Janet B. Grun, Elizabeth M.White, and Alexander F. Sito. November–December1992, p. 22.

Drug Formulation and DeliveryAn Early Warning Tool for Pharmaceutical

Development. Andrew P. Kerr, Lynn C. Klotz,Charles R. Morris, and Robert W. Schatz. March1992, p. 24.

Antibody-Mediated Delivery Systems. J.D. Rodwell,Ed. Reviewed by Umesh V. Banakar. October 1988,p. 40.

Biodegradable Hydrogels for Drug Delivery. KinamPark et al., Eds. Reviewed by Tarun K. Mandal.March 1994, p. 60.

Biomedical and Biotechnical Advances in IndustrialPolysaccharides. V. Crescenzi, I.C.M. Dea, S.Paoletti, S.S. Strivala, and I.W. Sutherland, Eds.Reviewed by Peter Lancy. March 1991, p. 30.

Biotechnological Polymers: Medical, Pharmaceutical,and Industrial Applications. Charles G. Gebelein,Ed. Reviewed by S. Subramanian.November–December 1993, p. 47.

Chemical Linkages in Drug-Antibody Conjugation.Wei-Chiang Shen, Stefano Persiani, and KrishnaSrivastava. January 1990, p. 16.

Chemical Stability of Pharmaceuticals, 2d ed. K.A.Connors, G.L. Amidon, and V.J. Stella. Reviewedby Umesh V. Banakar and Mario F. Sylvestri.January 1988, p. 47.

Controlled Drug Delivery, 2d ed. J.R. Robinson andV.H. Lee, Eds. Reviewed by Umesh V. Banakar.November 1987, p. 54.

Controlled Release of Biologically Active Agents. R.W.Baker. Reviewed by Umesh V. Banakar. November1987, p. 52.

Cyclodextrins and Biological Macromolecules. CharlesE. Strattan. November–December 1991, p. 44.


Drug Toxicokinetics. Peter G. Welling and Felix A. dela Iglesia, Eds. Reviewed by Richard M. Bauer.November 1994, p. 56.

Efficient Calcitonin Production. Ronald S. Levy. May1993, p. 36.

Freeze-Drying of Proteins, Part II: FormulationSelection. Michael J. Pikal. October 1990, p. 26.

Interferon Alpha Hybrids. M.A. Horisberger and H.K.Hochkeppel. March 1994, p. 50.

Intranasal Delivery of Proteins and Peptides. WilliamA. Lee and John P. Longenecker. April 1988, p. 30.

Lipid-Based Vehicles for Peptide and Protein Drugs,Part II: Manufacturing Variables. Alan L. Weiner.April 1990, p. 16.

Liposome Drug Delivery Systems. Guru V. Betageri,Scott A. Jenkins, and Daniel L. Parsons. Reviewedby Yashoda V. Pramar. July–August 1994, p. 50.

Liposomes as Drug Delivery Systems, Part 2:

Characterization. H. Talsma and D.J.A. Crommelin.November–December 1992, p. 38.

Liposomes as Drug Delivery Systems, Part 3:Stabilization. H. Talsma and D.J.A. Crommelin.March 1993, p. 40.

Liposomes: From Biophysics to Therapeutics. M.J.Ostro, Ed. Reviewed by Michael J. Groves. March1988, p. 52.

Materials Science and the Production of Shelf-StableBiologicals. Felix Franks, Ross H.M. Hatley, andSheila F. Mathias. October 1991, p. 38.

Nasal Systemic Drug Delivery. Y.W. Chien, K.S.E. Su,and S.-F. Chang. Reviewed by Umesh V. Banakar.October 1990, p. 47.

Novel Drug Delivery Systems, 2d ed. Yie W. Chien.Reviewed by Guru V. Betageri. January–February1993, p. 52.

Nucleic Acid Targeted Drug Design. C.L. Propst andThomas J. Perun, Eds. Reviewed by Larry M. Allen.March 1994, p. 59.



Oligonucleotides: Opportunities for Drug Therapy andResearch. Susanna Wu-Pong. November 1994, p.20.

Oral Route of Peptide and Protein Drug Delivery.Vincent H.L. Lee. July–August 1992, p. 39.

Orally Bioavailable Peptidelike Molecules: A CaseHistory. Hollis D. Kleinert, William R. Baker, andHerman H. Stein. January–February 1993, p. 36.

Peptide and Protein Drug Delivery Systems. VincentH.L. Lee. March 1988, p. 24.

Peptide and Protein Drug Delivery. Vol. 4, Advancesin Parenteral Sciences. Vincent H.L. Lee, Ed.Reviewed by Tarun Mandal. January–February1992, p. 54.

Peptides: A Target for New Drug Development. S.R.Bloom and G. Burnstock, Eds. Reviewed by BrianR. Shmaefsky. January–February 1992, p. 53.

Permeation Enhancers for the Nasal Delivery ofProtein and Peptide Therapeutics. William A. Lee.November–December 1990, p. 22.

Pharmaceutical Dosage Forms: ParenteralMedications, Vol. 1. 2d. ed. Kenneth E. Avis,Herbert A. Lieberman, and Leon Lachman, Eds.Reviewed by Sandeep Nema. October 1992, p. 45.

Pharmaceutical Dosage Forms: ParenteralMedications, Vol. 2. 2d ed. Kenneth E. Avis,Herbert A. Lieberman, and Leon Lachman.Reviewed by Carol DeSain. October 1993, p. 59.

Pharmaceutical Dosage Forms: ParenteralMedications, Vol. 3. 2d ed. Kenneth E. Avis, et al,Eds. Reviewed by Tarun K. Mandal.November–December 1993, p. 48.

Pharmaceutical Inhalation Aerosol Technology.Anthony J. Hickey. Reviewed by Eric J. Cornavaca.April 1993, p. 53.

Pharmaceutical Skin Penetration Enhancement.Kenneth A. Walters and Jonathan Hadgraft, Eds.Reviewed by Guru V. Betageri. October 1993, p.57.

Polyanhydrides for Controlled Drug Delivery. MarkChasin, Danny Lewis, and Robert Langer. February1988, p. 33.

Polymeric Drugs and Drug Delivery Systems. RichardL. Dunn and Raphael M. Ottenbrite, Eds. Reviewedby Morton Rosoff. January–February 1993, p. 52.

Polymers and Aggregate Systems. Vol. 1, ControlledRelease of Drugs. Morton Rosoff, Ed. Reviewed by

P.L. Madan. February 1991, p. 46.Preserving Dry Biomaterials: The Water Replacement

Hypothesis, Part 1. John H. Crowe, Lois M. Crowe,and John F. Carpenter. April 1993, p. 28.


Protein Design and the Development of NewTherapeutics and Vaccines. Jerry B. Hook andGeorge Poste, Eds. Reviewed by S. Subramanian.May 1992, p. 46.

Protein Pharmacokinetics and Metabolism. Bobbe L.Ferraiolo, Marjorie A. Mohler, and Carol A. Gloff,Eds. Reviewed by Yashoda V. Pramar. October1993, p. 58.

Scale-Up of Liposome Products. Robert J. Klimchakand Robert P. Lenk. February 1988, p. 18.

Site-Specific Drug Delivery. E. Tomlinson and S.S.Davis, Eds. Reviewed by Umesh V. Banakar. April1988, p. 50.

Specialized Drug Delivery Systems: Manufacturingand Production Technology. Vol. 41, Drugs and thePharmaceutical Sciences. Praveen Tyle, Ed.Reviewed by Jagdish Parasrampuria. July–August1990, p. 46.

Targeted Diagnosis and Therapy. Vol. 3, TargetedTherapeutic Systems. P. Tyle and B.P. Ram, Eds.Reviewed by Dolly Parasrampuria. January 1991,p. 49.

Technical Note: Calcium Alginate Hydrogel As aMatrix for Enteric Delivery of Nucleic Acids.Timothy J. Smith. April 1994, p. 54.

Topical Drug Delivery Formulations. Vol. 42, Drugsand the Pharmaceutical Sciences. D.W. Osbourne,Ed. Reviewed by Partha Banerjee. January 1991,p. 50.

Transdermal Controlled Systemic Medications. Y.W.Chien, Ed. Reviewed by Umesh V. Banakar.February 1988, p. 57.

Trehalose Drying: A Novel Replacement for Freeze-Drying. Bruce Roser. September 1991, p. 47.

Trends in Peptide and Protein Drug Delivery. VincentH.L. Lee. March 1991, p. 22.

Ultrasonics: Principles and Biomedical Applications.Pradeepkumar Sanghvi and Umesh V. Banakar.September 1991, p. 32.

Using a Microfluidizer to Manufacture ParenteralEmulsions. Deborah M. Lidgate, Roger C. Fu, andJeffrey S. Fleitman. October 1989, p. 28.

Drug Master FilesSee Master Files.

Education and TrainingBiotechnology Resource Guide: Update ’93. Jennifer

Winter, S. Anne Montgomery, and Karen Carlson.April 1993, p. 38.


Creative Ideas for GMP Training. Carolyn M. Orelli.September 1991, p. 42.

DNA Sequencing Support Service: LiteratureCollection and Video Program. United StatesBiochemical. Reviewed by Margaret A. Lindorfer.March 1991, p. 30.

Good Manufacturing Practices Training. Carolyn M.Orelli. April 1988, p. 38.

The Guild Handbook of Scientific Illustration. ElaineR.S. Hodges, Ed. Reviewed by Barbara A.Mickelson. March 1991, p. 30.

HIV in the Laboratory: Minimizing the Risk of

14 BioPharm Index


Exposure. Barbara H. Wagner and William N.Drohan. July–August 1988, p. 26.

Medical English Usage and Abusage. Edith Schwager.Reviewed by Jane Ganter. October 1992, p. 46.

PCR Technology: Principles and Applications for DNAAmplification. Henry A. Erlich, Ed. Reviewed byMargaret A. Lindorfer. March 1991, p. 32.

Pharmaceutical Biotechnology: A Programmed Text.S. William Zito, Ed. Reviewed by Hemanshu S.Shah. January–February 1993, p. 52.

Training People to Take Responsibility for Quality.David E. Nellis. October 1988, p. 24.


Viewpoint: Demystifying the “New” Biology. LeonardAnderson. March 1988, p. 16.


Viewpoint: NIH Support of Biotechnology. Ruth L.Kirschstein. February 1988, p. 14.

Viewpoint: Sailing with the Tide. Warren C. Hyer, Jr.January 1988, p. 14.

ElectrophoresisAdvances in Electrophoresis, Vol. 1. A. Chrambach,

M.J. Dunn, and B.J. Radola, Eds. Reviewed byHarold T. Spencer. February 1989, p. 47.

Analytical Biotechnology: Capillary Electrophoresisand Chromatography. Csaba Horváth and John G.Nikelly, Eds. Reviewed by Brian R. Shmaefsky.January–February 1992, p. 55.

Biotechnological Applications and Methods. Vol. 29,Advances in Chromatography. J.C. Giddings, E.Grushka, and P.R. Brown, Eds. Reviewed by JohnF. Fitzloff. January 1991, p. 49.

Capillary Electrophoresis: A New Era inMicroseparations. Norberto A. Guzman, LuisHernandez, and Bartley G. Hoebel. January 1989,p. 22.

Capillary Electrophoresis: Principles, Practice andApplications. S.F.Y. Li. Reviewed by Brian R.Shmaefsky. October 1993, p. 58.

Continuous Flow Electrophoresis: Resolving Real andApparent Heterogeneity. Rizwan Sharnez and DavidW. Sammons. January 1989, p. 54.

Free-Zone Capillary Electrophoresis: A SimpleComputer Program for Predicting Peptide MigrationTimes. Donald J. Pennino. September 1989, p. 41.

High-Resolution Electrophoretic Separations ofMegabase DNA Molecules. Karen Wert and AllenFurst. January 1989, p. 38.

Introduction to Capillary Electrophoresis of Proteinsand Peptides. H.E. Schwartz et al. Reviewed byLarry Litle. May 1994, p. 53.

A Practical Approach to the Analysis of 2-D Gels.Martha L. Booz. January 1989, p. 44.

Protein Purification: Principles, High ResolutionMethods, and Applications. J.-C. Janson and LarsRydén, Eds. Reviewed by S. Subramanian. February1991, p. 42.

Quantitative 2-D Electrophoresis and Computer-Assisted Analysis. Paul J. Collins and Marc R.Krauss. January 1989, p. 50.

Recirculating Isoelectric Focusing: A System forProtein Separations. Robert Kosecki. June 1988,p. 28.

Emerging Technologies“Emerging Technologies: FDA’s Quandary,” in

Regulatory Affairs. Nancy J. Chew. June 1993, p.20.

“Emerging Technologies: Transgenic Therapeutics,” inRegulatory Affairs. Nancy J. Chew. April 1993, p.24.


Nucleic Acid Targeted Drug Design. C.L. Propst andThomas J. Perun, Eds. Reviewed by Larry M. Allen.March 1994, p. 59.



Oligonucleotides: Opportunities for Drug Therapy andResearch. Susanna Wu-Pong. November 1994, p. 20.

Environmental IssuesAssessing Ecological Risks of Biotechnology. Lev R.

Ginzburg, Ed. Reviewed by Brian R. Shmaefsky.July–August 1991, p. 47.

“Biopharmaceuticals, FDA, and the Environment:Look before You NEPA,” in Regulatory Affairs.Jeffrey N. Gibbs. July–August 1989, p. 52.

Biotechnology Facility Requirements, Part II:Operating Procedures and Validation. Donald Hilland Michael Beatrice. November–December 1989,p. 28.

“The Environmental Impact of Biotechnology: A Viewfrom the Biopharmaceutical Industry,” inRegulatory Affairs. D.J. MacLean. June 1990, p. 19.

“Labeling Your Hazards,” in Regulatory Affairs.Nancy J. Chew and Rosanne M. Savol. April 1990,p. 11.

Perspectives in Plant Genetic Engineering andBiopharmacy. Jon Hughes and M. Walid Qoronfleh.May 1991, p. 18.

Viewpoint: A Risk-Free World? Justin Neway. April1993, p. 16.


Environmental Protection Agency“Biotechnology’s Promise and Challenge: Today’s

Patent and Regulatory Environments,” in BusinessMatters. G. Steven Burrill. September 1988, p. 22.

“Critical Concerns in Regulating BiotechnologyProducts,” in Regulatory Affairs. Albert A.Ghignone. September 1987, p. 28.



Viewpoint: Engineering the Cell-System Interface.Robert S. Cherry. July–August 1988, p. 14.

Enzymes Advances in Enzymology and Related Areas of

Molecular Biology, Vol. 65. Alton Meister, Ed.Reviewed by Yeldur P. Venkatesh. May 1993, p. 49.

Biotechnological Polymers: Medical, Pharmaceutical,and Industrial Applications. Charles G. Gebelein,Ed. Reviewed by S. Subramanian. November–December 1993, p. 47.

Enzyme Biotechnology: Protein Engineering, StructurePrediction, and Fermentation. Ellis Horwood Seriesin Biochemistry and Biotechnology. M.J.C. Crabbe,Ed. Reviewed by S. Subramanian. July–August1991, p. 50.

Enzymes in Industry: Production and Applications.Wolfgang Gerhartz, Ed. Reviewed by S.Subramanian. July–August 1991, p. 50.

Milestones in Biotechnology: Classic Papers onGenetic Engineering. Julian Davies and William S.Reznikoff, Eds. Reviewed by Karen Ettlinger. May1993, p. 50.

Enzyme ImmobilizationSee Immobilized Cell Culture.

Enzyme-Linked Immunosorbent AssaySee Analytical Techniques.

Establishment LicenseSee Regulatory Affairs Columns.

European Economic CommunitySee International Business.

Expression SystemsBovine Somatotropin Production: Selecting the Best

Host-Vector System. James F. Kane and GreggBogosian. November 1987, p. 26.


Genetically Engineered Proteins and Enzymes fromYeast: Production Control. Alan Wiseman, Ed.Reviewed by Dave Clark. October 1992, p. 46.


Production of Biologicals from Animal Cells inCulture. R.E. Spier, J.B. Griffiths, and B. Meignier,Eds. Reviewed by K. Jim Jem. May 1992, p. 53.

Recombinant DNA and Bacterial Fermentation.Jennifer A. Thomson, Ed. Reviewed by GreggBogosian. March 1990, p. 44.

Recombinant DNA Technology and Applications. AlesProkop, Rakesh K. Bajpai, and Chester S. Ho, Eds.Reviewed by Brian D. Kelley. April 1992, p. 50.

Yeasts and Yeast-Like Organisms. Anna Kocková-Kratochvílová. Reviewed by Brian Kelley.July–August 1991, p. 49.

Facility Design and Construction“cGMPs in Plant Design and Operation: A Step-by-

Step Guide,” in Regulatory Affairs. Frederick G.Harrison. March 1989, p. 24.

“Equipment Installation and Identification,” inDocumentation Basics. Carol DeSain.January–February 1992, p. 23.

An Integrated Approach to Validation. Arye Hess.March 1988, p. 42.


Bioprocess Development for Cost-Effective FacilityDesign. Edi D. Eliezer. May 1993, p. 24.

Bioprocess Engineering: Systems. Equipment andFacilities. Bjorn J. Lyderson, Nancy A. D’Elia, andKim L. Nelson, Eds. Reviewed by Carol DeSain.November 1994, p. 55.

Biotechnology Facility Requirements, Part I: Facility

BioPharm Index 15


and Systems Design. Donald Hill and MichaelBeatrice. October 1989, p. 20.

Building Quality in GMP Facilities. Jeffery N. Odum.June 1993, p. 42.

Compliance and Preparation for FDA Inspections.Drew R. Stoudt. January 1988, p. 39.



Design and Environmental Considerations for theModern Research Laboratory. Stanley Stark and JayKurtz. January 1994, p. 32.

Designing a Flexible Facility for Biopharmaceuticals.Ashot Petrossian, Nigel Smart, and Robert P.Proietto. July–August 1993, p. 40.

Developing a Program for Biopharmaceutical FacilityDesign. Jeffery N. Odum. May 1994, p. 36.


GMP Compliance in the Architecture and Constructionof Biopharmaceutical Manufacturing Facilities.Jeffery N. Odum. January–February 1993, p. 42.


Multiuse Manufacturing Facilities for Biologicals.Frederic G. Bader, Arthur Blum, Barry D.Garfinkle, David MacFarlane, Tobias Massa, andThomas L. Copmann, September 1992, p. 32.

New Role for Pilot Plants in Product Development.Robert Fahrner. April 1993, p. 34.

Project Management and Contracting Issues, Part I:Project Team Development. Andrew D. Skibo.April 1989, p. 46.

Project Management and Contracting Issues, Part II:Project Scope Development. Andrew D. Skibo. May1989, p. 24.

Project Management and Contracting Issues, Part III:Contracting Format and Contractor Selection.Andrew D. Skibo. July–August 1989, p. 34.

Safe Handling of Microorganisms in Small- and Large-Scale BL-3 Fermentation Facilities. Robert Z.Maigetter, F. James Bailey, and Brinton Miller.February 1990, p. 22.

Selecting an Engineering Firm: A Guide forBiotechnology Companies. Stephen Weil andGamal I. Amer. March 1994, p. 38.

Shock Waves at Cetus: Repair, ValidationConfirmation, Preparing for the Future. Richard M.Seegers. April 1990, p. 28.

To Renovate or Build New: Guidelines for EvaluatingConstruction Alternatives. Donald Robins andRobert Del Ciello. January 1988, p. 34.

Federal PoliciesSee Government Policies.

FiltrationBatch Production of Monoclonal Antibody by Large-

Scale Suspension Culture. William B. Lebherz III.February 1988, p. 22.

Carbon Filters, Sand Filters: Technology andApplication of Water Pretreatment Systems. Gopi R.Menon. March 1990, p. 33.


Clean-Water Permeability As a Determinant ofCleaning Efficacy in Tangential-Flow Filtration

Systems. Stephen L. Michaels. October 1994, p. 38.Crossflow Filtration: Theory and Practice. John

Murkes and Claes-Goran Carlsson. Reviewed byJohn J. Kearns. October 1990, p. 49.


Performance Testing of Membrane-Based Filters Usedin the Filtration of Industrial Fermentation Air. P.Keating, R. Levy, M. Payne, S. Proulx, P. Rowe,and S. Pearl. January–February 1992, p. 36.

Protein Recovery from Effluents of MicroporousMembranes. Jerold M. Martin and Richard L.Manteuffel. November–December 1988, p. 20.


Small Molecule Membrane Separation Processes.James L. Dwyer. September 1987, p. 71.

Technical Note: A Quantitative Method forChallenging 0.1 mm Rated Filters with A. laidlawii.J.T. Meeker, E.W. Hickey, J.M. Martin, and G.Howard, Jr. March 1992, p. 41.

Financial Strategies“Biotechnology Financing: Strategies after the

‘Crash,’” in Business Matters. G. Steven Burrill.April 1988, p. 14.

“The Biotechnology Industry: A First QuarterSnapshot,” in Business Matters. G. Steven Burrill.May 1988, p. 20.

“Biotechnology ’91: Adapting to a ChangingEnvironment,” in Business Matters. G. StevenBurrill. November–December 1990, p. 18.


“Biotechnology’s Promise and Challenge: Today’sPatent and Regulatory Environments,” in BusinessMatters. G. Steven Burrill. September 1988, p. 22.

“The Genentech-Roche Partnership: Responses andRepercussions,” in Business Matters. G. StevenBurrill. May 1990, p. 62.

Going Public — Step by Step. Alan J. Bowers. October1991, p. 44.

Going Public — Why and When. Alan J. Bowers.September 1991, p. 45.

“Managing in a Recessionary Environment: SomeTips,” in Business Matters. G. Steven Burrill. April1991, p. 37.

Partnering and Investing. Andrew P. Kerr, Lynn C.Klotz, Charles R. Morris, and Robert Schatz. June1991, p. 50.

Prescription for Finding a Strategic Partner. Donald R.Keer. November 1994, p. 34.

Private Placement — A Viable Alternative to an IPO.Bart J. Colli, Debra Groisser, and Karen De Paola.April 1992, p. 43.

“The Public Financing Window,” in Business Matters.Mark A. Young. October 1991, p. 48.

“Strategic Alliances, Foreign Investments: MeetingU.S. Biotechnology Financial, ProductDevelopment Needs,” in Business Matters. G.Steven Burrill. February 1990, p. 45.



“Vertical Integration: Dream or Pipe Dream?” inBusiness Matters. G. Steven Burrill. October 1988,p. 16.

Viewpoint: Corporate Partnering — One Company’sPerspective. Steven C. Mendell. June 1988, p. 16.


Viewpoint: The Great BioSeparations Debate —Sound and Fury, Signifying . . . ? Nancy E. Pfund.May 1994, p. 16.

GlycosylationSee Posttranslational Processing.

Good Laboratory PracticesDesign and Environmental Considerations for the

Modern Research Laboratory. Stanley Stark and JayKurtz. January 1994, p. 32.


Implementing International Good Practices: GAPs,GCPs, GLPs, and GMPs. Nigel J. Dent, Ed.Reviewed by Richard M. Bauer. July–August 1994,p. 52.

Occupational Health Perspective: Recombinant DNATechnology. Richard Cohen and Carol Lax Hoerner.June 1994, p. 28.

“Product Development and Registration, Part I:Understanding FDA Regulations,” in RegulatoryAffairs. Nancy J. Chew. April 1988, p. 18.

“Product Development and Registration, Part III:Researching for Safety and Effectiveness,” inRegulatory Affairs. Nancy J. Chew. June 1988,p. 23.

Good Manufacturing PracticesBiotechnology Facility Requirements, Part I: Facility



Biotechnology Product Validation, Part 1: Identifyingthe Pitfalls. James Akers, John McEntire, and GailSofer. January 1994, p. 40.

Building Quality in GMP Facilities. Jeffery N. Odum.June 1993, p. 42.

“cGMPs in Plant Design and Operation: A Step-by-Step Guide,” in Regulatory Affairs. Frederick G.Harrison. March 1989, p. 24.


Creative Ideas for GMP Training. Carolyn M. Orelli.September 1991, p. 42.

“Designing GMP and Facility Qualification MasterProtocols,” in Documentation Basics. Carol DeSain.April 1992, p. 18.

Documentation Basics That Support GoodManufacturing Practices. Carol DeSain. Reviewedby C. William Cherry. April 1993, p. 53.

Draft Guidelines on Good Automated ManufacturingPractice: A Conference Report. Martin Rosser. April1994, p. 28.

Drug, Device, and Diagnostic Manufacturing: TheUltimate Resource Handbook. Carol DeSain.Reviewed by Edward S. Balkovic. July–August1992, p. 48.

“Ensuring Parenteral Package Integrity,” in RegulatoryAffairs. Bernard L. Williams and Nancy J. Chew.April 1994, p. 22.

Environmental Requirements for Clean Rooms. John

16 BioPharm Index


Y. Lee. February 1989, p. 42.“Equipment Monitoring, Repair, Preventive

Maintenance,” in Documentation Basics. CarolDeSain. March 1992, p. 20.

Establishment of a Quality Control Laboratory: TheRole of Product Testing of Protein A. Bernadette L.Alford and Kathleen D. O’Donnell. October 1988,p. 32.

GMP Compliance in the Architecture and Constructionof Biopharmaceutical Manufacturing Facilities.Jeffery N. Odum. January–February 1993, p. 42.

GMP/ISO-9000, Quality Audit Manual for HealthcareManufacturers and Their Suppliers. LeonardSteinborn. Reviewed by Jean F. Huxsoll. April1993, p. 53.

Good Manufacturing Practices Training. Carolyn M.Orelli. April 1988, p. 38.



International Drug GMPs. 4th ed. Michael H.Anisfield, Ed. Reviewed by William Cherry.October 1993, p. 59.

Manufacture of Pharmacologically Active Proteins byMammalian Cell Culture. William R. Tolbert andWilliam R. Srigley. September 1987, p. 42.

“Master Production Batch Records,” in DocumentationBasics. Carol DeSain. November–December 1991,p. 20.





Sanitary Piping System Installation and GMPCompliance. Jeffery N. Odum. July–August 1992,p. 36.

Specialized Drug Delivery Systems: Manufacturingand Production Technology. Vol. 41, Drugs and thePharmaceutical Sciences. Praveen Tyle, Ed.Reviewed by Jagdish Parasrampuria. July–August1990, p. 46.

“Standard Operating Procedures and Data CollectionForms,” in Documentation Basics. Carol DeSain.October 1991, p. 22.



Viewpoint: Making Concurrent Process DevelopmentWork. Robert Fahrner. November–December 1993,p. 18.

Viewpoint: Manufacturing — The Next Frontier forBiotechnology. John Kossik and Geof Miller.September 1993, p. 22.

Government Policies“Are User Fees Meeting Their Intended Purpose?” in

Regulatory Affairs. Carson D. Gilbert and Nancy J.

Chew. July–August 1994, p. 20.Assessment of Genetic Stability for Biotechnology

Products. Committee on Process Development andManufacturing, Biotechnology Division, BiologicalSection, Pharmaceutical Manufacturers Association.February 1991, p. 22.

Barriers to Success: Hurdles in the BiotechnologyRace. John E. Bailey, Jr., Mark D. Dibner, and NoelP. Greis. March 1991, p. 16.

Biopharmaceuticals and Conventional Drugs:Comparing Development Times. Brigitta Bienz-Tadmor and Jeffrey S. Brown. March 1994, p. 44.

“Biotechnology ’91: Adapting to a ChangingEnvironment,” in Business Matters. G. StevenBurrill. November–December 1990, p. 18.

Biotechnology: EEC Policy on the Eve of 1993. OlivierLeroy, Director. Reviewed by William H. Cover.October 1992, p. 45.

“The Biotechnology Industry: A Midyear StatusReport,” in Business Matters. G. Steven Burrill.September 1990, p. 44.

Biotechnology Law for the 1990s: Analysis andPerspective. Vol. 4, BNA Special Report Series onBiotechnology. Geoffrey M. Karny, John J.Cohrssen, Edward L. Korwek, and Philip R. Reilly.Reviewed by David M. Einolf. February 1991,p. 40.


“The Continuing Debate: Making Health Care ReformWork for You,” in Regulatory Affairs. CarsonGilbert and Nancy J. Chew. November 1994, p. 16.



“Food for Thought,” in Regulatory Affairs. Nancy J.Chew. March 1991, p. 10.


“Health Care Reforms and Biopharmaceuticals,” inBusiness Matters. G. Steven Burrill.November–December 1992, p. 46.

“Labeling Your Hazards,” in Regulatory Affairs.Nancy J. Chew and Rosanne M. Savol. April 1990,p. 11.

“Master Files: Streamlining Your Submissions,Protecting Your Secrets,” in Regulatory Affairs.Donald J. Hinman and Nancy J. Chew. March 1990,p. 12.


“New Development Strategies for Life-ThreateningIllnesses,” in Regulatory Affairs. Michael R.Hamrell and Nancy J. Chew. July–August 1992,p. 18.


“1993 Revisited,” in Regulatory Affairs. Nancy J.Chew. January 1994, p. 18.


“Product Development and Registration,” inRegulatory Affairs. Nancy J. Chew. October 1991,p. 16.

“Rare Diseases, Orphan Products,” in RegulatoryAffairs. Nancy J. Chew. April 1991, p. 12.


“Reflections on 1990: Resources for RegulatoryAffairs,” in Regulatory Affairs. Nancy J. Chew.January 1991, p. 12.


“Regulatory Potpourri, Part 2: The Answer is. . .” inRegulatory Affairs. Nancy J. Chew. October 1994,p. 20.

“Regulatory Year in Review,” in Regulatory Affairs.Nancy J. Chew. January 1989, p. 18.


“Therapeutic Drugs for Life-Threatening Diseases,Part I: Expedited Review Reduces Drug Lag,” inRegulatory Affairs. Donald J. Hinman. September1990, p. 12.

“Therapeutic Drugs for Life-Threatening Diseases,Part II: Parallel-Track Protocols, Other AcceleratedPrograms,” in Regulatory Affairs. Donald J.Hinman. October 1990, p. 17.

“Today’s FDA: Its Vigorous, Forceful Leader,” inRegulatory Affairs. Nancy J. Chew. February 1991,p. 12.


Viewpoint: A Look into the 1990s — Association ofBiotechnology Companies. Pamela J. Bridgen. May1991, p. 15.



Viewpoint: Edwards Committee Final Report. Doris J.Bates. July–August 1991, p. 16.

“Washington’s Biotechnology Agenda,” in BusinessMatters. G. Steven Burrill. September 1989, p. 12.

“Who Pays?” in Regulatory Affairs. Nancy J. Chew.June 1991, p. 24.

Growth FactorsBlood Cell Growth Factors: Their Present and Future

Use in Hematology and Oncology. Martin J.Murphy Jr., Ed. Reviewed by Brian Shmaefsky.October 1992, p. 45.

Human Genome InitiativeSee Government Policies.

Human Immunodeficiency Virus (HIV)See Education and Training.

HVAC SystemsSee Controlled Environments.

Image AnalysisSee Analytical Techniques.

Immobilized Cell CultureBioreactor Immobilized Enzymes and Cells:

Fundamentals and Applications. Murray Moo-Young, Ed. Reviewed by Stanley S. Grossel. March

BioPharm Index 17


1990, p. 45.Gel-Immobilized Cell Culture for Monoclonal

Antibody Production. Philip C. Familletti.November 1987, p. 48.

Immobilized Biocatalysts: An Introduction. WinfriedHartmeier. Reviewed by Wayne Olson. February1991, p. 46.



Protein Immobilization: Fundamentals andApplications. Vol. 14, Bioprocess TechnologySeries. Richard F. Taylor, Ed. Reviewed by PatrickL. Coleman. July–August 1992, p. 48.



InactivationSee Downstream Processing.

Inclusion BodiesSee Posttranslational Processing.

Intellectual Property Rights“The Biotechnology Industry: A First Quarter

Snapshot,” in Business Matters. G. Steven Burrill.May 1988, p. 20.

“The Biotechnology Industry: A Midyear Snapshot,”in Business Matters. G. Steven Burrill. July–August1988, p. 17.



Depositing Organisms for Patent Purposes. Michael J.Wagner. July–August 1993, p. 26.

Drafting License Agreements. Michael A. Epstein andFrank L. Politano, Eds. Reviewed by Martin Meder.October 1992, p. 47.


“Master Files: Streamlining Your Submissions,Protecting Your Secrets,” in Regulatory Affairs.Donald J. Hinman and Nancy J. Chew. March 1990,p. 12.

Patent Law in Biotechnology, Chemicals andPharmaceuticals. Harold C. Wegner. Reviewed byAlan Liss. January 1994, p. 58.


Pharmaceuticals, Biotechnology and the Law. TrevorCook, et al., Eds. Reviewed by Richard M. Bauer.November–December 1993, p. 49.

The Scope of Patent Protection for PhysiologicallyImportant Proteins and Peptides. Michael B. Farberand Harris F. Brotman. April 1990, p. 22.

Trade Secret Protection. Robert W. Payne.January–February 1992, p. 42.

Trade-Secret Protection. Robert W. Payne. February1988, p. 47.

U.S. Legislation to Protect Biotechnology IntellectualProperty. Jeanette L. Murphy and Martha M.Rumore. November–December 1992, p. 32.



Will You Be Liable for Patent Infringement? SusanHaberman Griffen, Thomas L. Irving, and LawrenceM. Sung. July–August 1992, p. 26.

International Business“The Biotechnology Industry: A First Quarter


Biotechnology: EEC Policy on the Eve of 1993. OlivierLeroy, Director. Reviewed by William H. Cover.October 1992, p. 45.

Biotechnology in the United States and Japan: Who’son First? Mark D. Dibner and R. Steven White.February 1989, p. 22.

Biotechnology Japan 1990–1991: Company Directoryand Comprehensive Analysis. Reviewed by S. AnneMontgomery. September 1990, p. 51.


Drug Regulation in Japan: Can Foreign CompaniesPlay on Their Field? Mark D. Dibner. October 1989,p. 34.

“EEC Directives in Transition,” in Regulatory Affairs.Gillian Gregory. July–August 1991, p. 20.


An Exercise in Collaboration: Registration ofBiotechnology-Derived Pharmaceuticals in theEEC. R.A. Drost. September 1990, p. 28.

“The Export and Import of U.S. Biopharmaceuticals,”in Regulatory Affairs. Gail C. Corrado. February1989, p. 18.


International Strategic Alliances. Maria-LuisaMaccecchini. July–August 1991, p. 28.

Japan Pharmaceutical Handbook: Industry andCompanies, Spring 1990. Kazuaki Yonemoto andAki Yoshikawa. Reviewed by Mark D. Dibner.October 1991, p. 54.

“Regulation of Biopharmaceuticals in Europe and theUnited States: Viewpoint of a UK Manufacturer,” inRegulatory Affairs. K.J. Lambert and D.J. MacLean.February 1990, p. 16.

“Strategic Alliances, Foreign Investments: MeetingU.S. Biotechnology Financial, ProductDevelopment Needs,” in Business Matters. G.Steven Burrill. February 1990, p. 45.

“Toward a National Biotechnology Policy,” inBusiness Matters. G. Steven Burrill and Kenneth B.Lee. April 1990, p. 37.

“Toward EC ’92: Mixed Views, Unsettled Policies,” inThe Capitol Connection. Jill Wechsler. July–August1990, p. 17.

U.S. Legislation to Protect Biotechnology IntellectualProperty. Jeanette L. Murphy and Martha M.Rumore. November–December 1992, p. 32.

Viewpoint: Biotechnology — Offering New

Opportunities for Developing Countries. AgustinLage. June 1994, p. 18.


Viewpoint: NIH Support of Biotechnology. Ruth L.Kirschstein. February 1988, p. 14.

“Washington’s Biotechnology Agenda,” in BusinessMatters. G. Steven Burrill. September 1989, p. 12.

Investigational New Drug Applications“Clinical (and Other Concurrent) Development,” in

Regulatory Affairs. Nancy J. Chew. April 1992, p.12.

“Product Development and Registration: After the INDis Filed,” in Regulatory Affairs. Nancy J. Chew.March 1992, p. 14.


“Product Development and Registration, Part II:Preparing and Filing the IND,” in RegulatoryAffairs. Nancy J. Chew. May 1988, p. 24.


“Product Development and Registration, Part IV:Special INDs and Marketing Applications,” inRegulatory Affairs. Nancy J. Chew. July–August1988, p. 21.


“Therapeutic Drugs for Life-Threatening Diseases,Part II: Parallel-Track Protocols, Other AcceleratedPrograms,” in Regulatory Affairs. Donald J.Hinman. October 1990, p. 17.

Legal Issues“The Biotechnology Industry: A First Quarter


Biotechnology Law for the 1990s: Analysis andPerspective. Vol. 4, BNA Special Report Series onBiotechnology. Geoffrey M. Karny, John J.Cohrssen, Edward L. Korwek, and Philip R. Reilly.Reviewed by David M. Einolf. February 1991,p. 40.


Patent Law in Biotechnology, Chemicals andPharmaceuticals. Harold C. Wegner. Reviewed byAlan Liss. January 1994, p. 58.


Preventing Discrimination and Harassment in theWorkplace. Brent L. Wilson. March 1992, p. 38.


Trade Secret Protection. Robert W. Payne.January–February 1992, p. 42.

Trade-Secret Protection. Robert W. Payne. February1988, p. 47.


Will You Be Liable for Patent Infringement? SusanHaberman Griffen, Thomas L. Irving, and Lawrence

18 BioPharm Index


M. Sung. July–August 1992, p. 26.

LegislationSee Government Policies.

LipidsSee Drug Formulation and Delivery.

LiposomesSee Drug Formulation and Delivery.

Liquid-Liquid PartitioningSee Downstream Processing.

Mammalian Cell CultureAdvances in Animal Cell Biology and Technology for

Bioprocesses. R.E. Spier et al., Eds. Reviewed byWayne P. Olson. July–August 1990, p. 45.

Airlift Bioreactors for Production of MonoclonalAntibodies. G.P. Cortessis and C.M. Proby.November 1987, p. 30.

Animal Cell Technology: Principles and Products. M.Butler. Reviewed by George A. Robertson.February 1989, p. 46.

Batch Production of Monoclonal Antibody by Large-Scale Suspension Culture. William B. Lebherz III.February 1988, p. 22.



Fluorescent Measurement of Biomass in MammalianCell Cultures. Gregory J. MacMichael, William B.Armiger, George F. Lee, and Richard J. Krause.May 1988, p. 48.

Gel-Immobilized Cell Culture for MonoclonalAntibody Production. Philip C. Familletti.November 1987, p. 48.


Hybridoma Technology Products: Required VirusTesting. Eva Joner and Gary D. Christiansen.September 1988, p. 50.

Industrial Microorganisms: Basic and AppliedMolecular Genetics. Richard H. Baltz, George D.Hegeman, and Paul L. Skatrud, Eds. Reviewed byBrian R. Shmaefsky. October 1994, p. 53.



Inverted Microcarriers: Using Microencapsulation toGrow Anchorage-Dependent Cells in Suspension.Delano V. Young, Susan Dobbels, Louise King,Frank Deer, and Stephen D. Gillies.November–December 1989, p. 34.

Large Scale Cell Culture Technology. Vol. 10,Bioprocess Technology Series. Bjorn K. Lydersen,Ed. Reviewed by Paula T. Beall and SamMcKinney. September 1990, p. 50.

Large-Scale Mammalian Cell Culture Technology.Anthony S. Lubiniecki, Ed. Reviewed by K. JimJem. January–February 1992, p. 55.






Use of Porous Microcarriers in Agitated Cultures. E.Adema, D. Shnek, F. Cahn, and A.J. Sinskey.July–August 1990, p. 20.




Managing Your Career Columns“Analysis and Planning: Your Personal Marketing

Campaign, Part 1.” David G. Jensen. April 1991,p. 42.

“Analysis of a Career Change, Part 2: Reality Sets In.”Jack Cohen and David G. Jensen. April 1994, p. 60.

“Biotech Managers, Part 2: Obstacles to Transition.”David G. Jensen. October 1992, p. 43.

“Biotech Managers, Part 3: The New Manager.” DavidG. Jensen. November–December 1992, p. 49.

“Career Change Analysis, Part 1: Expectations.” JackCohen and David G. Jensen. March 1994, p. 57.

“Career Q&A.” David G. Jensen. May 1994, p. 51.“The Cover Letter: Introducing Yourself to a

Prospective Employer.” David G. Jensen. October1990, p. 46.

“Decisions, Decisions: Getting Things Done.” DavidG. Jensen. July–August 1992, p. 44.

“Effective Reward Systems.” David G. Jensen. May1992, p. 52.

“15 Minutes to a Better Interview.” David G. Jensen.March 1991, p. 14.

“Fine-Tuning Your Hiring Process.” David G. Jensen.March 1993, p. 48.

“The Hidden Agenda for Any Job Interview.” DavidG. Jensen. September 1990, p. 48.

“Hitting the Target: Your Personal MarketingCampaign, Part II.” David G. Jensen. May 1991,p. 50.

“Identifying Your Potential Successor.” David G.Jensen. June 1994, p. 82.

“The Job-Change Checklist.” David G. Jensen.November 1994, p. 53.

“Job Satisfaction.” David G. Jensen. July–August1991, p. 44.

“The Law of Reciprocity.” David G. Jensen. June1993, p. 60.

“Leadership Styles.” David G. Jensen. January 1991,p. 48.

“Meeting Mania.” David G. Jensen. September 1993,p. 60.

“Minding Your Career Clock.” David G. Jensen.November–December 1990, p. 48.

“More Project Champions.” David G. Jensen. October

1991, p. 51.“Moving Up or Moving On: Finding Your Acres of

Diamonds.” David G. Jensen. June 1990, p. 47.“New Career Tracks Call for Fresh Resume

Approaches.” David G. Jensen. May 1990, p. 68.“Out of the Lab, Into a New Career.” David G. Jensen.

May 1993, p. 47.“Overcoming Discomfort in Offer Negotiations.”

David G. Jensen. November–December 1993, p. 45.“Overcoming the Cinder Block Syndrome.” David G.

Jensen. July–August 1993, p. 53.“Pokes vs. Strokes: The Strokes Win.” David G.

Jensen. February 1991, p. 39.“Predictable Biotech Career Crises, Part 1.” David G.

Jensen. September 1994, p. 52.“Predictable Biotech Career Crises, Part 2: Career

Stages.” David G. Jensen. October 1994, p. 51.“Project Champions.” David G. Jensen. September

1991, p. 54.“Relate to Communicate.” David G. Jensen.

July–August 1990, p. 36.“The ‘Right’ Answer.” David G. Jensen. June 1992,

p. 68.“The “Seven Cs” of Control.” David G. Jensen.

July–August 1994, p. 48.“The 6 Biggest Biotech Career Mistakes, Part 1.”

David G. Jensen. January–February 1992, p. 51. “The 6 Biggest Biotech Career Mistakes, Part 2.”

David G. Jensen. March 1992, p. 52. “The 6 Biggest Biotech Career Mistakes, Part 3.”

David G. Jensen. April 1992, p. 46. “A Spirit of Interdependence.” David G. Jensen. June

1991, p. 60.“What to Look for in a New Boss.” David G. Jensen.

January 1994, p. 54.“Who’s In Charge Here?” David G. Jensen.

January–February 1993, p. 50.“Yesterday’s Wisdom, Today’s Realities.” David G.

Jensen. April 1993, p. 52.“You Will Never Be Appreciated.” David G. Jensen.

October 1993, p. 55.

Master Files“Master Files: Streamlining Your Submissions,

Protecting Your Secrets,” in Regulatory Affairs.Donald J. Hinman and Nancy J. Chew. March 1990,p. 12.



MediaSee Cell Growth and Viability.

Microbial FermentationComputers in Fermentation Technology. Vol. 25,

Progress in Industrial Microbiology. M.E. Bushell,Ed. Reviewed by Harold B. Reisman. April 1990,p. 44.


Fermentation Kinetics and Modelling. C.G. Sinclairand B. Kristiansen. Reviewed by Robert Z.Maigetter and George A. Robertson. January 1990,p. 42.

A Gradient-Feed Process for E. coli Fermentations.

BioPharm Index 19


B.R. Allen and G.W. Luli. November 1987, p. 38.Industrial Microorganisms: Basic and Applied

Molecular Genetics. Richard H. Baltz, George D.Hegeman, and Paul L. Skatrud, Eds. Reviewed byBrian R. Shmaefsky. October 1994, p. 53.

Recombinant DNA and Bacterial Fermentation.Jennifer A. Thomson, Ed. Reviewed by GreggBogosian. March 1990, p. 44.

Scale-Down Techniques for Fermentation. KwanminJim Jem. March 1989, p. 30.

Special Microbial Processes. Vol. 6B, Biotechnology.H.-J. Rehm and G. Reed, Eds. Reviewed by HaroldB. Reisman. October 1990, p. 47.

Validation of Fermentation Processes. Thomas J.Naglak, Michael G. Keith, and Daniel R. Omstead.July–August 1994, p. 28.

MicrocarriersSee Mammalian Cell Culture.

Monoclonal AntibodiesAirlift Bioreactors for Production of Monoclonal

Antibodies. G.P. Cortessis and C.M. Proby.November 1987, p. 30.


C-Terminal Modification Occurs in Tissue CultureProduced OKT3. Patricia Rao, Allan Williams,Alysia Baldwin-Ferro, Eileen Hanigan, DanielKroon, Mary Makowski, Eric Meyer, VanchaiNumsuwan, Ellen Rubin, and An Tran.November–December 1991, p. 38.

Commercial Production of Monoclonal Antibodies: AGuide for Scale-Up. S.S. Seaver, Ed. Reviewed byUmesh V. Banakar. January 1988, p. 46.




Monoclonal Antibodies in Biotechnology: Theoreticaland Practical Aspects. Vol. 8, Cambridge Studies inBiotechnology. Kenneth C. McCullough andRaymond E. Spier. Reviewed by Patrick L.Coleman. July–August 1991, p. 48.

Monoclonal Antibodies in Cancer Therapy: ThePresent and the Future. Jeffrey Schlom. September1988, p. 44.

Monoclonal Antibodies: A Manual of Techniques. H.Zola. Reviewed by Umesh V. Banakar. March 1988,p. 51.

Monoclonal Antibodies: Production and Application.Vol. 11, Advances in Biotechnological Processes.Avshalom Mizrahi, Ed. Reviewed by Arthur Kunz.January 1990, p. 49.

A Practical Guide to Monoclonal Antibodies. J. ErylLiddel and A. Cryer. Reviewed by Brian R.Shmaefsky. July–August 1992, p. 49.

“Product Development and Registration, Part II:Preparing and Filing the IND,” in RegulatoryAffairs. Nancy J. Chew. May 1988, p. 24.

Removing Specific Cell Culture Contaminants in a

MAb Purification Process. Lewis S. Hanna, PerlaPine, Gary Reuzinsky, Somesh Nigam, and DanielR. Omstead. October 1991, p. 33.

Monoclonal Antibody RecoverySee Protein/Polypeptide Recovery.

New Drug Applications“Beyond Customer Satisfaction: Quality First in

Regulatory Planning,” in Regulatory Affairs. NancyJ. Chew. October 1988, p. 20.

“Can-Do Marketing Applications,” in RegulatoryAffairs. Nancy J. Chew. March 1993, p. 22.

New Drug Approval Process, 2d ed. Richard A.Guarino. Reviewed by William E. Heary. October1993, p. 60.

“Now It’s Your Turn,” in Regulatory Affairs. Nancy J.Chew. November–December 1990, p. 14.




Orphan Drugs“Patents, Regulations, Orphans Affect Biopharm

Industry,” in The Capitol Connection. Jill Wechsler.May 1990, p. 20.

“Rare Diseases, Orphan Products,” in RegulatoryAffairs. Nancy J. Chew. April 1991, p. 12.




PatentsSee Intellectual Property Rights.

Peptide MappingSee Analytical Techniques.

Peptide SynthesisBiologically Active Peptides: Design, Synthesis, and

Utilization. William V. Williams and David B.Weiner, Eds. Reviewed by Brian R. Shmaefsky.May 1993, p. 49.

Efficient Calcitonin Production. Ronald S. Levy. May1993, p. 36.


Surface Reactive Peptides and Polymers: Discoveryand Commercialization. ACS Symposium Series444. C. Steven Sikes and A.P. Wheeler, Eds.Reviewed by Morton Rosoff. July–August 1992, p.50.

Synthetic Peptides in Biotechnology. Vol. 10, Advancesin Biotechnological Processes. Avshalom Mizrahi,Ed. Reviewed by Bruce L. Currie. July–August

1990, p. 41.

Personnel Issues“Biotech Managers, Part 2: Obstacles to Transition,” in

Managing Your Career. David G. Jensen. October1992, p. 43.

“Biotech Managers, Part 3: The New Manager,” inManaging Your Career. David G. Jensen.November–December 1992, p. 49.

“Effective Reward Systems,” in Managing YourCareer. David G. Jensen. May 1992, p. 52.

Finding the Right Scientist: Working with aHeadhunter. James S.J. Manuso. October 1989,p. 44.

How to Manage the R&D Staff: A Looking-GlassWorld. James E. Tingstad. Reviewed by Doris J.Bates. May 1992, p. 42.

A Matter of Degree? Doris J. Bates. October 1991,p. 30.

“More Project Champions,” in Managing Your Career.David G. Jensen. October 1991, p. 51.



Preventing Discrimination and Harassment in theWorkplace. Brent L. Wilson. March 1992, p. 38.

Safe Handling of Microorganisms in Small- and Large-Scale BL-3 Fermentation Facilities. Robert Z.Maigetter, F. James Bailey, and Brinton Miller.February 1990, p. 22.

Scientists as Entrepreneurs: OrganizationalPerformance in Scientist-Started New Ventures.Karel J. Samson. Reviewed by Thomas A. Smith.July–August 1991, p. 46.

“A Spirit of Interdependence,” in Managing YourCareer. David G. Jensen. June 1991, p. 60.

Viewpoint: Managing Organizational Growth. RobertJ. Beckman. January–February 1993, p. 20.


Plant BiotechnologyThe New Biotechnology: Technology Assessment and

Market Potential. Linda Lee Bower. Reviewed byLarry Allen. November 1994, p. 54.


Plant Cell and Tissue Culture in Liquid Systems. G.F.Pahyne, V. Bringi, C. Prince, and M.L. Shuler, Eds.Reviewed by Brian Shmaefsky. October 1992, p.47.

Posttranslational ProcessingBlood Cell Growth Factors: Their Biology and

Clinical Applications. Supplement 1 to Vol. 8,International Journal of Cell Cloning. Martin J.Murphy, Jr., and Vittorio Rizzoli, Eds. Reviewed byWayne Olson. February 1991, p. 42.


Integrated Process Design for Producing andRecovering Proteins from Inclusion Bodies. N.J.Titchener-Hooker, D. Gritsis, R. Olbrich, S.A.M.Gardiner, K. Mannweiler, N.M. Fish, and M. Hoare.July–August 1991, p. 34.

20 BioPharm Index


Manufacturing New-Generation Proteins, Part II:Process Design and Quality Management. P.M.Hammond, T. Atkinson, R.F. Sherwood, and M.D.Scawen. May 1991, p. 30.

Protein Biosynthesis. H.R.V. Arnstein and R.A. Cox.Reviewed by Yeldur P. Venkatesh. April 1993, p.54.

Protein Engineering: Approaches to the Manipulationof Protein Folding. Vol. 14, Biotechnology Series.Saran A. Narang, Ed. Reviewed by Barbara A.Whittaker. July–August 1991, p. 49.


Process AutomationSee Automation.

Process Control/MonitoringAssessment of Genetic Stability for Biotechnology

Products. Committee on Process Development andManufacturing, Biotechnology Division, BiologicalSection, Pharmaceutical Manufacturers Association.February 1991, p. 22.

Biomedical and Clinical Instrumentation: FastTracking from Concept through Production in aRegulated Environment. Robert Meltzer. Reviewedby Carol DeSain. November 1994, p. 56.

Bioprocess Monitoring and Control. Marie-NoëllePons, Ed. Reviewed by John J. Prior. March 1993,p. 50.



Computer System Validation: InstallationQualification. J.S. Alford and F.L. Cline. September1990, p. 32.


Control Charts for Bioprocess Control. Barbara K.Kimball. June 1988, p. 46.


Freeze-Drying of Proteins, Part I: Process Design.Michael J. Pikal. September 1990, p. 18.

Installation and Operational Qualification of PLCSystems. Roger Notarian. October 1993, p. 46.


Lot Release — Final Product Safety Testing forBiologics. Leonard J. Schiff, W. Alan Moore, JimBrown, and Martin H. Wisher. June 1992, p. 36.


Process Engineering in Biotechnology. InternationalSeries in the Physical and Engineering Sciences.A.T. Jackson. Reviewed by Brian Kelley.July–August 1991, p. 47.

Process Validation for Virus Removal and

Inactivation. Elizabeth M. White, Janet B. Grun,Chong-Son Sun, and Alexander F. Sito. May 1991,p. 34.

Protein Purification Process Engineering. Roger G.Harrison, Ed. Reviewed by Eric J. Cornavaca.July–August 1994, p. 51.




Products and MarketingBiopharmaceuticals and Conventional Drugs:

Comparing Development Times. Brigitta Bienz-Tadmor and Jeffrey S. Brown. March 1994, p. 44.



“The Biotechnology Industry: 1988 in Review,” inBusiness Matters. G. Steven Burrill. January 1989,p. 14.

“Biotechnology Product Pricing: Issues, Concerns, andStrategies,” in Business Matters. G. Steven Burrill.June 1989, p. 12.

Drafting License Agreements. Michael A. Epstein andFrank L. Politano, Eds. Reviewed by Martin Meder.October 1992, p. 47.

An Early Warning Tool for PharmaceuticalDevelopment. Andrew P. Kerr, Lynn C. Klotz,Charles R. Morris, and Robert W. Schatz. March1992, p. 24.

“Emerging Issues for Biopharmaceutical Companies,”in Business Matters. G. Steven Burrill. October1990, p. 43.


From Science to Technology. Charles L. Cooney. June1993, p. 32.

“Getting Permission to Market in the U.S.,” inRegulatory Affairs. Nancy J. Chew. June 1992, p.22.

“Inspections, Recalls, Seizures: Who’s in Control?” inRegulatory Affairs. Nancy J. Chew.November–December 1988, p. 14.


Packaging Drugs and Pharmaceuticals. Wilmer A.Jenkins and Kenton R. Osborn. Reviewed byYashoda V. Pramar. July–August 1994, p. 50.

“Product Development and Registration,” inRegulatory Affairs. Nancy J. Chew.January–February 1992, p. 19.


“Reimbursement and Value Pricing,” in BusinessMatters. G. Steven Burrill and Kent Thompson.February 1991, p. 36.


“Therapeutic Drugs for Life-Threatening Diseases,Part II: Parallel-Track Protocols, Other Accelerated

Programs,” in Regulatory Affairs. Donald J.Hinman. October 1990, p. 17.

“Vertical Integration: Dream or Pipe Dream?” inBusiness Matters. G. Steven Burrill. October 1988,p. 16.


Viewpoint: Test Kit Endorsements — A DilemmaFacing Us All. Robert C. Rund. October 1988,p. 14.

“Where’s Industry Going in ’89?” in Business Matters.G. Steven Burrill. March 1989, p. 18.

Professional Societies/AssociationsProfessional Societies and Associations. S. Anne

Montgomery. January 1991, p. 37.Professional Societies and Associations.

January–February 1992, p. 46. Professional Societies and Associations. Jennifer

Winter. January–February 1993, p. 46.Professional Societies and Associations. Denise

Wendt. January 1994, p. 44.“Reflections on 1990: Resources for Regulatory

Affairs,” in Regulatory Affairs. Nancy J. Chew.January 1991, p. 12.

Viewpoint: A Look into the 1990s — Association ofBiotechnology. Pamela J. Bridgen. May 1991, p. 15.

Protein DenaturationSee Downstream Processing.

Protein FoldingSee Posttranslational Processing.

Protein/Polypeptide RecoveryThe Cytokine Handbook. Angus W. Thomson, Ed.

Reviewed by Jeanna L. Welborn. March 1993, p.50.

Cytokines. Anthony Meager. Reviewed by Jeanna L.Welborn. March 1993, p. 50.









Protein Recovery from Effluents of MicroporousMembranes. Jerold M. Martin and Richard L.

BioPharm Index 21


Manteuffel. November–December 1988, p. 20.Purification of a Mouse-Human Chimeric Fab Secreted

from E. coli. Patrick Gavit, Mike Walker, TimWheeler, Phiet Bui, Shau-Ping Lei, and JoachimWeickmann. January–February 1992, p. 28.





Uridine Phosphorylase Purified from Total CrudeExtracts of E. coli: Using Q Sepharose and Radial-Flow Chromatography. Kurt Weaver, David Chen,Leslie Walton, Lynn Elwell, and Paul Ray.July–August 1990, p. 25.

Protein PrecipitationSee Posttranslational Processing.

Protein SequencingAutomated Protein Microsequencing: Using an Amino

Acid Homopolymer as an Internal Standard. JamesBausch and Wasyl Sydor. May 1989, p. 40.


Methods in Protein Sequence Analysis. B. Wittmann-Liebold, Ed. Reviewed by Thomas S. Vedvick.January 1991, p. 50.


PCR Protocols: A Guide to Methods and Applications.Michael A. Innis et al., Eds. Reviewed by MargaretA. Lindorfer. January–February 1992, p. 54.

PCR Technology: Principles and Applications for DNAAmplification. Henry A. Erlich, Ed. Reviewed byMargaret A. Lindorfer. March 1991, p. 32.

Primary Structure Analysis of Recombinant Proteins.Stanley Stein. February 1989, p. 30.

Protein/Peptide Sequence Analysis: CurrentMethodologies. A.S. Bhown, Ed. Reviewed byUmesh V. Banakar. July–August 1988, p. 44.

RNA Editing: The Alteration of Protein CodingSequences of RNA. Rob Benne, Ed. Reviewed byLarry M. Allen. March 1994, p. 59.



Sequence Analysis Primer. Michael Gribskov and JohnDevereux, Eds. Reviewed by William A. Mehl.January–February 1993, p. 52.

Public Policy“The Biotechnology Industry: A Midyear Status

Report,” in Business Matters. G. Steven Burrill.September 1990, p. 44.

“Emerging Issues for Biopharmaceutical Companies,”in Business Matters. G. Steven Burrill. October1990, p. 43.

Massachusetts’s Policy Environment. Greg Watsonand Fernando Quezada. September 1987, p. 66.

“Reimbursement and Value Pricing,” in BusinessMatters. G. Steven Burrill and Kent Thompson.February 1991, p. 36.

“Toward a National Biotechnology Policy,” inBusiness Matters. G. Steven Burrill and Kenneth B.Lee. April 1990, p. 37.

Viewpoint: Cancer Research: A Public Trust. RobertK. Oldham. March 1991, p. 8.

Viewpoint: Demystifying the “New” Biology. LeonardAnderson. March 1988, p. 16.


Viewpoint: Opportunistic Opposition toBiotechnology. Burt D. Ensley. March 1993, p. 20.

Purified WaterSee Water Systems.

Quality Assurance/Quality ControlATCC Quality Control Methods for Cell Lines. 2d ed.

American Type Culture Collection. Reviewed byEdward S. Balkovic. April 1993, p. 53.


“Beyond Customer Satisfaction: Quality First inRegulatory Planning,” in Regulatory Affairs. NancyJ. Chew. October 1988, p. 20.






Control Charts for Bioprocess Control. Barbara K.Kimball. June 1988, p. 46.


Establishment of a Quality Control Laboratory: TheRole of Product Testing of Protein A. Bernadette L.Alford and Kathleen D. O’Donnell. October 1988,p. 32.



“Lot Numbers,” in Documentation Basics. CarolDeSain. September 1991, p. 26.

Lot Release — Final Product Safety Testing forBiologics. Leonard J. Schiff, W. Alan Moore, JimBrown, and Martin H. Wisher. June 1992, p. 36.

Manufacturing New-Generation Proteins, Part II:Process Design and Quality Management. P.M.

Hammond, T. Atkinson, R.F. Sherwood, and M.D.Scawen. May 1991, p. 30.

Parenteral Quality Control: Sterility, Pyrogen,Particulate and Package Integrity Testing, 2d ed.Michael J. Akers. Reviewed by Carol DeSain.July–August 1994, p. 50.

“Part Number Specifications,” in DocumentationBasics. Carol DeSain. July–August 1991, p. 24.

“Part Numbers,” in Documentation Basics. CarolDeSain. June 1991, p. 28.


Quality Assurance and Quality Control (QA/QC) inBiocare: Autolymphocyte Therapy as a Model. GaryC. du Moulin, Dylan L. Hamilton, John E. Price,Zenobia J. Kosik, Y.-S. Victor Liu, and Michael E.Osband. July–August 1990, p. 30.




Stainless Steels for Bioprocessing, Part 4:Procurement, QA/QC. C.P. Dillon, D.W. Rahoi, andA.H. Tuthill. July–August 1992, p. 31.

Technical Note: A Quantitative Method forChallenging 0.1 mm Rated Filters with A. laidlawii.J.T. Meeker, E.W. Hickey, J.M. Martin, and G.Howard, Jr. March 1992, p. 41.

Training People to Take Responsibility for Quality.David E. Nellis. October 1988, p. 24.

Use of the Limulus Amebocyte Lysate (LAL) Assay inLiving Cell Therapies. Gary C. du Moulin, John E.Price, Yuan-Jin Shen, and Michael E. Osband.March 1992, p. 32.

Using Mass Spectrometry to CharacterizeRecombinant Proteins. Bertrand Monegier, FrançoisFrédéric Clerc, Alain Van Dorsselaer, MarcVuilhorgne, Brian Green, and Terence Cartwright.November–December 1990, p. 26.




Viewpoint: Surviving and Thriving in Quality Control.Timothy W. Ryan. May 1993, p. 16.

Regulatory Affairs Columns“Are User Fees Meeting Their Intended Purpose?”

Carson D. Gilbert and Nancy J. Chew. July–August1994, p. 20.

“Beyond Customer Satisfaction: Quality First inRegulatory Planning.” Nancy J. Chew. October1988, p. 20.

“Biopharmaceuticals, FDA, and the Environment:Look before You NEPA.” Jeffrey N. Gibbs.July–August 1989, p. 52.

“Can-Do Marketing Applications.” Nancy J. Chew.March 1993, p. 22.

“cGMPs in Plant Design and Operation: A Step-by-Step Guide.” Frederick G. Harrison. March 1989,p. 24.

“Characters and Personalities: How They AffectRegulatory Processes.” Nancy J. Chew. September

22 BioPharm Index


1989, p. 20.“Clinical (and Other Concurrent) Development.”

Nancy J. Chew. April 1992, p. 12. “Clinical Trials for AIDS Treatments.” Michael R.

Hamrell. September 1991, p. 22.“Clinical Trials for In Vitro Diagnostics, Part 1. “

Martha A. Feldman and Nancy J. Chew.November–December 1992, p. 16.

“Clinical Trials for In Vitro Diagnostics, Part 2,”Martha A. Feldman and Nancy J. Chew.January–February 1993, p. 24.

“The Continuing Debate: Making Health Care ReformWork for You.” Carson Gilbert and Nancy J. Chew.November 1994, p. 16.

“Critical Concerns in Regulating BiotechnologyProducts.” Albert A. Ghignone. September 1987,p. 28.

“Development and Registration.” Nancy J. Chew.March 1994, p. 20.

“Drug Price Controls: A Changing Reality.” ElizabethR. Carder, Debra A. McCurdy, and Nancy J. Chew.May 1993, p. 18.

“EEC Directives in Transition.” Gillian Gregory.July–August 1991, p. 20.

“Emerging Technologies: FDA’s Quandary.” Nancy J.Chew. June 1993, p. 20.

“Emerging Technologies: Transgenic Therapeutics.”Nancy J. Chew. April 1993, p. 24.

“Ensuring Parenteral Package Integrity.” Bernard L.Williams and Nancy J. Chew. April 1994, p. 22.

“The Environmental Impact of Biotechnology: A Viewfrom the Biopharmaceutical Industry.” D.J.MacLean. June 1990, p. 19.

“The Export and Import of U.S. Biopharmaceuticals.”Gail C. Corrado. February 1989, p. 18.

“Food for Thought.” Nancy J. Chew. March 1991,p. 10.

“Getting Permission to Market in the U.S..” Nancy J.Chew. June 1992, p. 22.

“Inspections, Recalls, Seizures: Who’s in Control?”Nancy J. Chew. November–December 1988, p. 14.

“Labeling Your Hazards.” Nancy J. Chew andRosanne M. Savol. April 1990, p. 11.

“Managing the Validation Process.” Thomas Smithand Nancy J. Chew. November–December 1993, p.24.

“Master Files: Streamlining Your Submissions,Protecting Your Secrets.” Donald J. Hinman andNancy J. Chew. March 1990, p. 12.

“New Development Strategies for Life-ThreateningIllnesses.” Michael R. Hamrell and Nancy J. Chew.July–August 1992, p. 18.

“New Rules and Regs Rain on IVD Parade.” RosanneM. Savol and Nancy J. Chew. October 1992, p. 16.

“1993 Revisited.” Nancy J. Chew. January 1994, p. 18.“Now It’s Your Turn.” Nancy J. Chew.

November–December 1990, p. 14.“Nutraceuticals: Using Food to Treat Disease.” Nancy

J. Chew. July–August 1993, p. 18.“OBRR Answers Common Regulatory Questions.”

Madge L. Crouch. November 1987, p. 16.“Opening the Line of Communication.” Nancy J.

Chew. March 1988, p. 22.“Product Development and Registration, Part I:

Understanding FDA Regulations.” Nancy J. Chew.April 1988, p. 18.

“Product Development and Registration, Part II:Preparing and Filing the IND.” Nancy J. Chew. May1988, p. 24.

“Product Development and Registration, Part III:Researching for Safety and Effectiveness.” Nancy J.Chew. June 1988, p. 23.

“Product Development and Registration, Part IV:Special INDs and Marketing Applications.” NancyJ. Chew. July–August 1988, p. 21.

“Product Development and Registration, Part V: InVitro Diagnostic Products.” Rosanne Savol.September 1988, p. 28.

“Product Development and Registration.” Nancy J.Chew. October 1991, p. 16.

“Product Development and Registration.” Nancy J.Chew. January–February 1992, p. 19.

“Product Development and Registration: After the INDis Filed.” Nancy J. Chew. March 1992, p. 14.

“A Profession Comes of Age: The Regulatory AffairsCertification Program.” Nancy J. Chew. October1989, p. 14.

“Rare Diseases, Orphan Products.” Nancy J. Chew.April 1991, p. 12.

“Reflections on 1989: Framing Events for the Year toCome.” Nancy J. Chew and Gail C. Corrado.January 1990, p. 14.

“Reflections on 1990: Resources for RegulatoryAffairs.” Nancy J. Chew. January 1991, p. 12.

“Regulation of Biopharmaceuticals in Europe and theUnited States: Viewpoint of a UK Manufacturer.”K.J. Lambert and D.J. MacLean. February 1990,p. 16.

“Regulations as Business Assets.” Nancy J. Chew.May 1990, p. 14.

“Regulatory Affairs: A Window on the World.” NancyChew and Rosanne Savol. May 1989, p. 18.

“Regulatory Potpourri, Part 1.” Nancy J. Chew.September 1994, p. 20.

“Regulatory Potpourri, Part 2: The Answer is...” NancyJ. Chew. October 1994, p. 20.

“Regulatory Year in Review.” Nancy J. Chew. January1989, p. 18.

“Sterilization Process Validation.” Nancy J. Chew.October 1993, p. 20.

“The Supplier’s Role in Validation.” Paul J. Leonesioand Nancy J. Chew. May 1994, p. 28.

“Therapeutic Drugs for Life-Threatening Diseases,Part I: Expedited Review Reduces Drug Lag.”Donald J. Hinman. September 1990, p. 12.

“Therapeutic Drugs for Life-Threatening Diseases,Part II: Parallel-Track Protocols, Other AcceleratedPrograms.” Donald J. Hinman. October 1990, p. 17.

“Today’s FDA: Its Vigorous, Forceful Leader.” NancyJ. Chew. February 1991, p. 12.

“The Vaccines of Biotechnology: New Interest in OldRegulations.” Nancy J. Chew and Gail C. Corrado.June 1989, p. 24.

“Validating Products Derived from Continuous CellLines.” Martha J. Carter and Richard A. Scotland.November–December 1989, p. 24.

“Validation: What Does It Prove?” Donald J. Hinmanand Nancy J. Chew. July–August 1990, p. 12.

“Validation: When Too Much Is Not Enough.” NancyJ. Chew. September 1993, p. 28.

“Veterinary Biologics.” Janis K. McMillen. January1988, p. 16.

“When an Invention Becomes a Product.” Nancy J.Chew. November–December 1991, p. 14.

“Who Pays?” Nancy J. Chew. June 1991, p. 24.

Regulatory IssuesBarriers to Success: Hurdles in the Biotechnology

Race. John E. Bailey, Jr., Mark D. Dibner, and NoelP. Greis. March 1991, p. 16.

Biologics Development: A Regulatory Overview. MarkMathieu, Ed. Reviewed by Richard M. Bauer. May1994, p. 53.

Biomedical and Clinical Instrumentation: Fast

Tracking from Concept through Production in aRegulated Environment. Robert Meltzer. Reviewedby Carol DeSain. November 1994, p. 56.

Biopharmaceuticals and Conventional Drugs:Comparing Development Times. Brigitta Bienz-Tadmor and Jeffrey S. Brown. March 1994, p. 44.

Biotechnology Facility Requirements, Part I: Facilityand Systems Design. Donald Hill and MichaelBeatrice. October 1989, p. 20.


“The Biotechnology Industry: A First QuarterSnapshot,” in Business Matters. G. Steven Burrill.May 1988, p. 20.




“Clinical Trials for AIDS Treatments,” in RegulatoryAffairs. Michael R. Hamrell. September 1991, p. 22.


The Design and Analysis of Sequential Clinical Trials,2d ed. John Whitehead. Reviewed by Damon S.Anthony. November–December 1993, p. 47.

Drug Biotechnology Regulation: Scientific Basis andPractices. Vol. 13, Bioprocess Technology Series.Yuan-yuan H. Chiu and John L. Gueriguian, Eds.Reviewed by James Fenno. January–February 1992,p. 54.

Drug Regulation in Japan: Can Foreign CompaniesPlay on Their Field? Mark D. Dibner. October 1989,p. 34.

“EEC Directives in Transition,” in Regulatory Affairs.Gillian Gregory. July–August 1991, p. 20.

“Emerging Technologies: FDA’s Quandary,” inRegulatory Affairs. Nancy J. Chew. June 1993, p.20.

“Emerging Technologies: Transgenic Therapeutics,” inRegulatory Affairs. Nancy J. Chew. April 1993,p. 24.






GMP/ISO-9000, Quality Audit Manual for HealthcareManufacturers and Their Suppliers. LeonardSteinborn. Reviewed by Jean F. Huxsoll. April1993, p. 53.

HVAC Systems for Biopharmaceutical ManufacturingPlants. Manuel A. del Valle. April 1989, p. 26.


BioPharm Index 23


“Managing the Validation Process,” in RegulatoryAffairs. Thomas Smith and Nancy J. Chew.November–December 1993, p. 24.

Massachusetts’s Policy Environment. Greg Watsonand Fernando Quezada. September 1987, p. 66.

A Matter of Degree? Doris J. Bates. October 1991,p. 30.

“New Development Strategies for Life-ThreateningIllnesses,” in Regulatory Affairs. Michael R.Hamrell and Nancy J. Chew. July–August 1992, p.18.

New Drug Approval Process. 2d ed. Richard A.Guarino. Reviewed by William E. Heary. October1993, p. 60.

New Drug Development: A Regulatory Overview.Mark Mathieu. Reviewed by Doris J. Bates. October1991, p. 54.


New Rules and Regs Rain on IVD Parade. Rosanne M.Savol and Nancy J. Chew. October 1992, p. 16.

Packaging Drugs and Pharmaceuticals. Wilmer A.Jenkins and Kenton R. Osborn. Reviewed byYashoda V. Pramar. July–August 1994, p. 50.

“Part Numbers,” in Documentation Basics. CarolDeSain. June 1991, p. 28.




“Product Development and Registration: After the INDis Filed,” in Regulatory Affairs. Nancy J. Chew.March 1992, p. 14.

“Reflections on 1990: Resources for RegulatoryAffairs,” in Regulatory Affairs. Nancy J. Chew.January 1991, p. 12.

“Today’s FDA: Its Vigorous, Forceful Leader,” inRegulatory Affairs. Nancy J. Chew. February 1991,p. 12.

Troubleshooting Validation Failures. Robert N.Borghese. March 1993, p. 28.


Viewpoint: Edwards Committee Final Report. Doris J.Bates. July–August 1991, p. 16.


Viewpoint: Regulating Biotechnology. Frank E.Young. September 1987, p. 24.



Scale-Up StrategiesAdvances in Animal Cell Biology and Technology for

Bioprocesses. R.E. Spier et al., Eds. Reviewed byWayne P. Olson. July–August 1990, p. 45.

Airlift Bioreactors for Production of MonoclonalAntibodies. G.P. Cortessis and C.M. Proby.November 1987, p. 30.


Biotechnology Product Validation, Part 2: A LogicalPlan. James Akers, John McEntire, and Gail Sofer.

March 1994, p. 54.C-Terminal Modification Occurs in Tissue Culture

Produced OKT3. Patricia Rao, Allan Williams,Alysia Baldwin-Ferro, Eileen Hanigan, DanielKroon, Mary Makowski, Eric Meyer, VanchaiNumsuwan, Ellen Rubin, and An Tran.November–December 1991, p. 38.


Commercial Production of Monoclonal Antibodies: AGuide for Scale-Up. S.S. Seaver, Ed. Reviewed byUmesh V. Banakar. January 1988, p. 46.












Protein Purification: From Molecular Mechanisms toLarge-Scale Processes. Vol. 427, ACS SymposiumSeries. Michael R. Ladisch, Richard C. Wilson,Chih-duen C. Painton, and Stuart E. Builder, Eds.Reviewed by Louis C. Smith. July–August 1991,p. 46.



Scale-Down Techniques for Fermentation. KwanminJim Jem. March 1989, p. 30.

Scale-Up and Validation of Sedimentation Centrifuges,Part 1: Scale-Up. J.T. Mahar. September 1993, p. 42.




Separation and PurificationAn Analysis of Clearance Factor Measurements

Performed by Spiking Experiments. Thomas C.Hageman. July–August 1991, p. 39.



Bioseparation Steps for Proteins and Other BiologicalProducts, Part 1: Cell Disruption. Ajit Sadana.March 1994, p. 26.

Bioseparation Steps in Processing Proteins and OtherBiological Products, Part 2: Initial Fractionation.Ajit Sadana. April 1994, p. 34.

Biotechnology Product Validation, Part 4: Clearance of Impurities from Protein and PeptideBiotherapeutics. Gail Sofer. May 1994, p. 46.

Chiral Separations by Liquid Chromatography. ACSSymposium Series #471. Satinder Ahuja, Ed.Reviewed by Kenneth H. Brown. July–August1992, p. 50.



Crystallization as a Separations Process. Allan S.Myerson and Ken Toyokura, Eds. Reviewed byStanley S. Grossel. October 1991, p. 54.

Cyclodextrins and Biological Macromolecules. CharlesE. Strattan. November–December 1991, p. 44.

Determination of Leakage Products fromChromatographic Media Aimed for ProteinPurification. Bo-Lennart Johansson. April 1992,p. 34.

Downstream Processing and Bioseparation: Recoveryand Purification of Biological Products. ACSSymposium Series #419. Jean-François P. Hamel,Jean B. Hunter, and Subhas K. Sikdar, Eds.Reviewed by Brian D. Kelley. February 1991, p. 40.

Extractive Bioconversions. Bo Mattiasson and OlleHolst, Eds. Reviewed by Stanley S. Grossel. March1993, p. 51.


Fluid Sterilization by Filtration. Peter R. Johnston.Reviewed by William E. Heary. October 1993, p. 57.

Guide to Protein Purification. Vol. 182, Methods inEnzymology. Murray P. Deutscher, Ed. Reviewed byKaren D. Larison. January–February 1992, p. 53.

High-Resolution Electrophoretic Separations ofMegabase DNA Molecules. Karen Wert and AllenFurst. January 1989, p. 38.


Inorganic Membranes: Synthesis, Characteristics, andApplications. Ramesh R. Bhave, Ed. Reviewed byKenneth H. Brown. May 1993, p. 49.



24 BioPharm Index


Peristaltic Pumps in Low-Pressure LC Systems. PeterG. Brown. March 1988, p. 46.

Polymer Applications for Biotechnology. David S.Soane, Ed. Reviewed by Umesh Banakar. June1993, p. 74.

Process Validation for Virus Removal andInactivation. Elizabeth M. White, Janet B. Grun,Chong-Son Sun, and Alexander F. Sito. May 1991,p. 34.


Protein Purification Using Affinity Ligands Deducedfrom Peptide Libraries. George A. Baumbach andDavid J. Hammond. May 1992, p. 24.

Protein Purification: Principles and Practices, 2d ed.R.K. Scopes. Reviewed by Umesh V. Banakar.October 1988, p. 38.

Purification and Analysis of Recombinant Proteins.Vol. 12, Bioprocess Technology Series. RamnathSeetharam and Satish K. Sharma, Eds. Reviewed byBrian R. Shmaefsky. May 1992, p. 42.

Purification of a Mouse-Human Chimeric Fab Secretedfrom E. coli. Patrick Gavit, Mike Walker, TimWheeler, Phiet Bui, Shau-Ping Lei, and JoachimWeickmann. January–February 1992, p. 28.

Recirculating Isoelectric Focusing: A System forProtein Separations. Robert Kosecki. June 1988,p. 28.





Separation Chemistry. Fedor Macasek and James D.Navratil. Reviewed by Kenneth H. Brown. March1994, p. 60.




Techniques in Biocompatibility Testing, Vol. 2. D.F.Williams, Ed. Reviewed by Umesh V. Banakar.May 1989, p. 45.

Viewpoint: The Great BioSeparations Debate —Sound and Fury, Signifying . . . ? Nancy E. Pfund.May 1994, p. 16.


Sera and Serum SubstitutesSee Cell Growth and Viability.Technical Note: A Dual Formulation Serum-Free

Media System. M.V. Caple, T.R. Fletcher, W.J.Owens, S. Harada, T.J. Murphy, and B.J. Walthall.June 1992, p. 52.

Standard Operating ProceduresControlling Contamination in Bioprocessing. Casimir

A. Perkowski. September 1987, p. 62.Documentation Requirements in the Biotechnology

Industry. M. Vasilevsky and C.W. Cherry. October1990, p. 32.



State LegislationSee Government Policies.

Utility DesignBioprocess Engineering: Systems, Equipment and

Facilities. Bjorn J. Lyderson, Nancy A. D’Elia, andKim L. Nelson, Eds. Reviewed by Carol DeSain.November 1994, p. 55.



Clean-in-Place System Design. Dan G. Adams andDeepak Agarwal. June 1989, p. 48.

“Equipment and Utility System Validation Protocols,”in Documentation Basics. Carol DeSain. May 1992,p. 21.





Sanitary Piping System Installation and GMPCompliance. Jeffery N. Odum. July–August 1992,p. 36.

Sizing Clean-Steam Generators. Dan Adams.November–December 1988, p. 36.



Stainless Steels for Bioprocessing, Part 3: CorrosionPhenomena. C.P. Dillon, D.W. Rahoi, and A.H.Tuthill. June 1992, p. 40.

Stainless Steels for Bioprocessing, Part 4:Procurement, QA/QC. C.P. Dillon, D.W. Rahoi, andA.H. Tuthill. July–August 1992, p. 31.

Water for Injection System Design. Edward E.Bjurstrom and Drew Coleman. November 1987,p. 42.

Water Systems for Biotechnology Facilities. Edward E.Bjurstrom and Drew Coleman. September 1987,p. 50.

VaccinesBiomedical and Biotechnical Advances in Industrial

Polysaccharides. V. Crescenzi, I.C.M. Dea, S.Paoletti, S.S. Strivala, and I.W. Sutherland, Eds.March 1991, p. 30.


Immunology: Clinical, Fundamental, and TherapeuticAspects. Bhanu P. Ram, Mary C. Harris, andPraveen Tyle, Eds. Reviewed by M. Sue Preston.October 1991, p. 54.


Protein Design and the Development of NewTherapeutics and Vaccines. Jerry B. Hook andGeorge Poste, Eds. Reviewed by S. Subramanian.May 1992, p. 46.


“The Vaccines of Biotechnology: New Interest in OldRegulations,” in Regulatory Affairs. Nancy J. Chewand Gail C. Corrado. June 1989, p. 24.

Viral Vaccines. Vol. 14, Advances in BiotechnologicalProcesses. Avshalom Mizrahi, Ed. Reviewed byRichard R. Spaete. July–August 1991, p. 49.

ValidationAssessment of Genetic Stability for Biotechnology

Products, Committee on Process Development andManufacturing, Biotechnology Division, BiologicalSection, Pharmaceutical Manufacturers Association.February 1991, p. 22.


Biotechnology Product Validation, Part 1: Identifyingthe Pitfalls. James Akers, John McEntire, and GailSofer. January 1994, p. 40.

Biotechnology Product Validation, Part 2: A LogicalPlan. James Akers, John McEntire, and Gail Sofer.March 1994, p. 54.


Biotechnology Product Validation, Part 4: Clearance ofImpurities from Protein and PeptideBiotherapeutics. Gail Sofer. May 1994, p. 46.



Biotechnology Product Validation, Part 7: Validationof Chromatography Resin Useful Life. Robert J.Seely, Hugh D. Wight, Holly H. Fry, Scott R.Rudge, and Geoffery F. Slaff. September 1994, p. 41.

Biotechnology Product Validation, Part 8:Chromatography Media and Column Qualification.Anne R. Barry and Robert Chojnacki. November1994, p. 43.

Clean-in-Place System Design. Dan G. Adams andDeepak Agarwal. June 1989, p. 48.



Computer System Validation — Staying Current:Introduction. K.G. Chapman and J.R. Harris(Pharmaceutical Manufacturers Association). May1989, p. 30.

Computer System Validation — Staying Current:Software Development Testing Strategies. E.J.

BioPharm Index 25


Subak Jr. (Pharmaceutical ManufacturersAssociation). September 1989, p. 24.


Computer System Validation, Part II: EvaluatingVendor Software. Leonard J. Goren. February 1989,p. 38.


Computer System Validation: Change Control. JamesAgalloco (Pharmaceutical ManufacturersAssociation). May 1990, p. 38.

Computer System Validation: InstallationQualification. J.S. Alford and F.L. Cline(Pharmaceutical Manufacturers Association).September 1990, p. 32.




Draft Guidelines on Good Automated ManufacturingPractice: A Conference Report. Martin Rosser. April1994, p. 28

“Equipment and Utility System Validation Protocols,”in Documentation Basics. Carol DeSain. May 1992,p. 21.




“Managing the Validation Process,” in RegulatoryAffairs. Thomas Smith and Nancy J. Chew.November–December 1993, p. 24.

“Master Method Validation Protocols,” inDocumentation Basics. Carol DeSain. June 1992,p. 30.

Methods Used to Validate Microporous Membranesfor the Removal of Mycoplasma. Kerry L. Rocheand Richard V. Levy. April 1992, p. 22.

An Overview of Test Method Validation. Darwin R.Williams. November 1987, p. 34.



Process Validation for Virus Removal andInactivation. Elizabeth M. White, Janet B. Grun,Chong-Son Sun, and Alexander F. Sito. May 1991,p. 34.

“Process Validation Protocols,” in DocumentationBasics. Carol DeSain. July–August 1992, p. 22.


Scale-Up and Validation of Sedimentation Centrifuges,Part 1: Scale-Up. J.T. Mahar. September 1993, p.42.


Shock Waves at Cetus: Repair, ValidationConfirmation, Preparing for the Future. Richard M.Seegers. April 1990, p. 28.

“Sterilization Process Validation,” in RegulatoryAffairs. Nancy J. Chew. October 1993, p. 20.

“The Supplier’s Role in Validation” in RegulatoryAffairs. Paul J. Leonesio and Nancy J. Chew. May1994, p. 28.

Technical Note: A Quantitative Method forChallenging 0.1 mm Rated Filters with A. laidlawii.J.T. Meeker, E.W. Hickey, J.M. Martin, and G. Howard, Jr. March 1992, p. 41.



Troubleshooting Validation Failures. Robert N.Borghese. March 1993, p. 28.




“Validation: What Does It Prove?” in RegulatoryAffairs. Donald J. Hinman and Nancy J. Chew.July–August 1990, p. 12.

“Validation: When Too Much Is Not Enough,” inRegulatory Affairs. Nancy J. Chew. September1993, p. 28.

Viewpoint: “Manufacturing — The Next Frontier forBiotechnology,” John Kossik and Geof Miller.September 1993, p. 22.


Water SystemsBiotechnology Facility Requirements, Part I: Facility


Carbon Filters, Sand Filters: Technology andApplication of Water Pretreatment Systems. Gopi R.Menon. March 1990, p. 33.



“Rouge” and Its Removal from High-Purity WaterSystems. Gopi R. Menon. June 1990, p. 40.

Updating USP Waters Monographs and Tests: PMA-Proposed Changes. Emil G. Ginev. September 1993,p. 52.

Water for Injection System Design. Edward E.Bjurstrom and Drew Coleman. November 1987,p. 42.

Water Systems for Biotechnology Facilities. Edward E.Bjurstrom and Drew Coleman. September 1987,p. 50. BP