prep 2016 preliminary scientific...

PREP 2016 Preliminary Scientific Program of 34

—PREP 2016 Preliminary Scientific Program— Click Here to Submit Poster Abstracts

(program as of 7-6-2016)

PREP 2016 Chair

Giorgio Carta, University of Virginia

Organizing Committee

Lois Ann Beaver, LAB Enterprises Giorgio Carta, University of Virginia (Chair) Olivier Dapremont, AMPAC Fine Chemicals

Igor Quinones-Garcia, Shire Qi (Tony) Yan, Pfizer

Scientific Advisory Committee Dorota Antos, Rzeszow University of Technology, Poland Steven Cramer, Rensselaer Polytechnic Institute Attila Felinger, University of Pecs, Hungary Ranga Godavarti, Pfizer Kent Goklen, GlaxoSmithKline Art Hewig, Amgen Alois Jungbauer, BOKU, Vienna, Austria Abraham Lenhoff, University of Delaware

Massimo Morbidelli, ETH Zurich, Switzerland David Robbins, MedImmune David Roush, Merck & Co., Inc. Melody Schmidt, Genentech Andreas Seidel-Morgenstern, Max-Planck Institute, Magdeburg, Germany Owen Thomas, University of Birmingham, UK Shuichi Yamamoto, Yamaguchi University, Japan

Industrial Advisory Committee

Jonathan Edelman, Washington Chromatography Discussion Group Marc Jacob, Phenomenex Mayumi Kiyono-Shimobe, Mitsubishi Chemical Corporation Jiali Liao, Bio-Rad Laboratories

Ceclia Mazza, AkzoNobel/Kromasil Kathleen Mihlbachler, LEWA Process Technologies Ernie Sobkow, YMC America Eric Valery, Novasep Alla Zilberman, Semba Biosciences

Symposium / Exhibit Manager

Ms. Janet Cunningham, Barr Enterprises Phone 301-668-6001

[email protected] LinkedIn.com/in/BarrEnterprises

PREPsymposium.org

The use of still or video cameras and cell phones is prohibited during the oral program; and prohibited in the poster and exhibition areas without the express consent of the presenter or exhibitor. Opinions expressed by

presenters, instructors and exhibitors are not necessarily the opinions of the PREP 2016 Symposium.

http://prepsymposium.org/abstract-papers.html


Sunday Workshop and Tutorial Training Program The Workshop and Tutorial Training Program provides advanced tutorials covering various aspects of preparative and process chromatography. Workshops and Tutorial are open to conference and non-conference participants. See details and pricing posted online under "Workshops & Tutorial" at PREPsymposium.org. Must pre-register to attend.

Sunday, July 17 Workshops (See registration form for cost) Instructors

9:00am-12:30pm Commonwealth Hall A1

Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Processes Focus on biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and resolution, multicolumn and continuous chromatography processes.

Giorgio Carta, University of Virginia Alan Hunter, MedImmune Alois Jungbauer, BOKU, Vienna Massimo Morbidelli, ETH Zurich

12:30pm-4:00pm Commonwealth Hall A2

Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC Focus on small molecule pharmaceuticals, APIs, chiral molecules, peptides, oligonucleotides, HPLC, column packing, gradient elution, overloaded chromatography, continuous chromatography, SMB, SFC, examples and industrial applications.

Olivier Dapremont, Ampac Fine Chemicals

4:00pm-6:30pm Commonwealth Hall A1

Regulatory Fundamentals, QbD, and Design of Experiments for Biopharmaceuticals Focus on regulatory aspects, QbD/DOE principles and practical examples, Process Analytical Technology, Quality System Management, biosimilars.

Lois Ann Beaver, LAB Enterprises Gisela Ferreira, MedImmune

Monday, July 18 Tutorial (See registration form for cost) Instructors

7:00am-8:30am Commonwealth Hall A1

Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography Focus on analytical chromatography, overloaded chromatography, HPLC, SFC, examples of small molecules, APIs, peptides.

Cecilia Mazza, AkzoNobel Tony Yan, Pfizer, Inc.

http://prepsymposium.org/workshop-tutorial.html

http://www.prepsymposium.org/


Poster Competition Poster presentations are a very important component of the PREP Symposia. In order to acknowledge their contribution to the field and high standards of the symposium, awards will be offered to distinguish the best poster contributions at PREP 2016. Posters will be evaluated on the basis of scientific content, clarity of presentation, and layout. Posters co-authored by members of the Scientific and Industrial Advisory Committees or by judges are eligible only if the main author and presenter of the poster is not a member on the above committees. Posters authored or co-authored by members of the Organizing Committee or judges are not eligible for Best Poster Awards. However, should these posters be considered of sufficient quality to be among the top prize-winning entries, they will be given an Honorable Mention. The Poster Judging Committee will have final say in the selection of the Prize Winners. At least two committee members will read each poster and top posters will be read by at least four committee members. If a poster author does not want his/her poster considered for a poster award, they must notify the Symposium Manager before 11:00 a.m. on Tuesday, July 19. Presentation of awards to winners of the Best Poster Competition will take place at the end of the Wednesday morning sessions. The winners are encouraged to be present, but it is not mandatory to be present to win.

PREP Symposium Conference History

1985 Washington DC 2002 Washington DC

1986 Washington DC 2003 San Francisco, CA

1987 Washington DC 2004 Baltimore, MD

1989 Washington DC 2005 Philadelphia, PA



1994 Washington DC 2008 San Jose, CA



1997 Washington DC 2011 Cambridge, MA

1998 Washington DC 2012 Cambridge, MA

1999 San Francisco, CA 2013 Boston, MA

2000 Washington DC 2014 Boston, MA




Workshop 1: Sunday, July 17, at 9:00 am - 12:30 pm Fundamentals of Preparative Chromatography for Biomolecule Purification

by Batch and Continuous Chromatography Workshop registration is in addition to the symposium registration fee;

open to conference and non-conference participants. Location: Commonwealth Hall A1 -- must pre-register/pay to attend

Focus: Biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and resolution, multicolumn and continuous chromatography processes. This workshop will focus on the theory and practice of biomolecule chromatography. Since mass transfer and the structure of the stationary phase influence deeply chromatographic performance, the main emphasis is on describing adsorption/desorption kinetics in single and multicomponent systems and determining the relationship between stationary phase properties and process performance. The latest advances in stationary phase developments will be reviewed along with methods for their experimental characterization. Design and optimization strategies for capture and resolution applications will be discussed including multicolumn and continuous bio-chromatography processes. Topics: Adsorption equilibrium and transport in single and multicomponent systems; Stationary phases for small and large biomolecules; Design and optimization of batch processes for capture and high-resolution steps; Multicolumn and continuous bio-chromatography processes; Process validation. Expert Instructors: Giorgio Carta received his Ph.D. in Chemical Engineering from the University of Delaware in 1984. Since then he has been a professor in the Department of Chemical Engineering at the University of Virginia, where his research focuses on transport phenomena and bioseparations. He regularly organizes professional courses on various aspects of bioseparations, including a course on protein chromatography development and scale-up together with Alois Jungbauer.

Alan Hunter received his Ph.D. in Chemical Engineering from the University of Virginia in 2002 and is currently Fellow in the Process Biochemistry Group at MedImmune. Prior to joining MedImmune he held positions of Process Engineer at Cambrex Bio Science Baltimore, and of Senior Principal Scientist at Pfizer Biologics. Dr. Hunter has broad biotechnology experience and expertise in areas including process development for large-scale cGMP manufacture of biologics, recombinant biopharmaceutical purification, and technology transfer and scale-up.

Alois Jungbauer is the head of protein technology and downstream processing at the Department of Biotechnology of the University of Natural Resources and Applied Life Sciences in Vienna (Austria). For more than 20 years, Professor Jungbauer has worked in biochemical engineering, with a focus on bioseparation, where he has published widely and holds 15 patents. For over 10 years, he has organized a biennial professional course in protein chromatography focused on mass transfer, dispersion, and scale-up.

Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in 1986. After appointments as professor at the University of Cagliari (Italy) and at the Politecnico di Milano, since 1997 he is Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His research interests are in polymer reactions and reaction-separation processes based on continuous chromatography and in biomolecule purification with specific focus on therapeutic proteins and monoclonal antibodies. He is co-author of more than 300 papers, 11 international patents and 4 books. He serves as an associate editor of Industrial & Engineering Chemistry Research, and is a member of the scientific board of several international journals. He is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers.


Workshop 2: Sunday, July 17, at 12:30 - 4:00 pm Fundamentals of Preparative Chromatography for Purification of APIs, Peptides,

and Oligonucleotides by Batch Chromatography, SMB, and SFC Workshop registration is in addition to the symposium registration fee;


Focus: Small molecules, APIs, peptides, oligonucleotides, chiral molecules, HPLC, column packing, gradient elution, overloaded chromatography, SFC, SMB, examples and industrial applications.

This workshop will focus on development of methods for the preparative purification of small molecules for the pharmaceutical industry. After an introduction of the theory, optimization and practice of prep HPLC, SMB and SFC for small molecule separations, the instructors will present practical approaches to the development of preparative separation through a series of examples. The attendees will learn valuable information and techniques to apply in the laboratory and at manufacturing scale to increase throughput and performance.

Topics: Prep HPLC batch - Theory, optimization and practice; SMB - Principle and technology; SMB - Examples and applications; SFC - Theory, equipment and examples.

Expert Instructor:

Olivier Dapremont received is PhD on Chemical Engineering and Applied Chemistry from University of Paris on the development of continuous chromatography for the pharmaceutical industry. He has worked on the development of SMB technology since 1992. He is currently Executive Director of Process Technologies at AMPAC Fine Chemicals where his role encompasses the development of SMB separations using multiple SMB units ranging from 4.6 mm to 1 m in diameter as well as developing continuous processes for the manufacturing of APIs. He is coauthor of several publications and patents related to the use of SMB applications for the purification of small molecules.


Workshop 3: Sunday, July 17, at 4:00 - 6:30 pm Regulatory Fundamentals, QbD, and

Design of Experiments for Biopharmaceuticals Workshop registration is in addition to the symposium registration fee;


Focus: This workshop will focus on Quality by Design, Quality Systems Management, Science-based Risk Management, Process Analytical Technology and Continuous Process Improvement as tools that can be incorporated into basic drug development processes. We will examine the relationship between good drug development science, quality and regulatory flexibility, with emphasis on application to the biopharmaceutical industry. Particular attention will be placed on the practice of Quality by Design. A practical study of how the integration of quality and risk management is used in an application to bring a mAb to market will be presented. In addition, we will address the challenges for technology and regulation created by the emerging biosimilars industry along with the current status of internationally developed guidance.

Topics: Regulatory aspects, QbD, Process Analytical Technology, Quality System Management, Biosimilars

Expert Instructors:

Lois Ann Beaver, after a multi-decade career with the U.S. Food and Drug Administration, in 2009 founded a regulatory consulting group, LAB Enterprises. While working in FDA's Office of the Commissioner, Lois served on the FDA Pharmaceutical Quality Council that conceived and developed quality by design; led activity for FDA's joining the international Pharmaceutical Inspection Cooperation Scheme; worked as liaison with international organizations such as WHO, most recently focusing on biosimilars; managed the export program for international investigations of unapproved pharmaceuticals; was associate director for international harmonization working on international best practice and standardization activities such as the ICH; was US Coordinator for Veterinary ICH; and served as delegate to the APEC (Asia Pacific Economic Cooperation) Life Sciences Innovation Forum. Lois also led international projects on anti-counterfeiting of medical products and good manufacturing practices in pharmaceutical firms in emerging countries, and established a pharmaceutical information center in Cairo.

Gisela Ferreira received her Ph.D. in Chemical Engineering from the University of Maryland Baltimore County in 2001 and is currently Senior Scientist in the Process Biochemistry Group at MedImmune. Prior to joining MedImmune she held positions as Senior Scientist at Medarex in the downstream department. Dr. Ferreira has broad biotechnology experience and expertise in areas including process development for large-scale cGMP manufacture of biologics, recombinant biopharmaceutical purification (early and late stage development), QbD, technology transfer and scale-up.


Tutorial: Monday, July 18, at 7:00 - 8:30 am Tips, Tricks, and Troubleshooting

Analytical and Overloaded Prep Chromatography Tutorial registration is in addition to the symposium registration fee;


Focus: Analytical chromatography, overloaded chromatography, HPLC, SFC, examples of small molecules, APIs, peptides

This workshop will focus on the practical aspects of analytical and preparative chromatography, scale-up, and how to overcome the challenges that the chromatographer encounters on a daily basis by using the tips and tricks provided. Topics: Analytical and Preparative chromatography purpose, practical scaleup, issues with peak shape, considering the whole chromatographic system (equipment, column and software) as contributors to the final chromatographic result, troubleshooting tools for improved chromatographic performance.

Expert Lecturers:

Cecilia Mazza has worked with small molecules, APIs, peptides and proteins for twenty five years, both in analytical as well as preparative chromatography. She is product manager and regional sales manager for Kromasil columns and bulk at AkzoNobel in Sweden. Tony Yan is currently working for Pfizer, Inc. (Groton, CT, USA) in the field of impurity isolation for structure elucidation in the department of pharmaceutical science. He has worked in pharmaceutical research and development in the area of chiral and achiral purifications, and impurity isolation for over 20 years.


Preliminary List of Sponsors, Exhibitors, Media Partners

Agilent Technologies

AkzoNobel/Kromasil

American Laboratory

American Pharmaceutical Review

Ampac Fine Chemicals

Avantor Performance Materials

Bioanalysis-Zone

BioProcessing Journal

Bio-Rad Laboratories

Bristol-Myers Squibb

DAISO Fine Chem USA

Essential Life Solutions & emp Biotech

GE Healthcare Life Sciences

Genentech

GENews

GlaxoSmithKline

International LabMate/Chromatography Today

ITOCHU Chemicals America

JASCO

JNC America

JSR Life Sciences

Kaneka

Lab Manager Magazine

LabCompare

LCGC

MedImmune

Merck

NOVASEP

Pfizer

Purolite Life Sciences

Quantum Analytics

Semba Biosciences

Separation Methods Technologies

Separation Science

Shire

SP Scientific-Genevac

Thermo Fisher Scientific

YMC America

YPSO-FACTO


Free Vendor Workshops Monday, July 18, 2016

Must pre-register at the sponsor's booth to attend; light lunch will be provided

12:45-2:00 PM A Bead for Every Need, from MAb Purification to Uranium Extraction,

sponsored by Purolite Life Sciences Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Purolite by Monday @ 10:50 AM Purolite has been developing resins for over 35 years. The seminar will focus on our newly developed chromatography platform for life science applications. It is based on highly hydrophilic agarose resins (Praesto

TM) for protein purification, including four

different Protein A resins, as well as synthetic polymer beads (ChromaliteTM

) for purification of small and hydrophobic biomolecules.

12:45-2:00 PM Utilizing Novel Mixed-Mode Selectivities for Challenging Chromatography

Separations, sponsored by Bio-Rad Laboratories Location: Commonwealth Hall A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of Bio-Rad Laboratories by Monday @ 10:50 AM Presenters: Jiali Liao, Ph.D., Principal Scientist I, Process Chromatography, Bio-Rad Laboratories; Mark A. Snyder, Ph.D., Manager, Applications R&D Group, Process Chromatography, Bio-Rad Laboratories; and Xuemei He, Ph.D., R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories Mixed-mode chromatography has been widely used in the purification of monoclonal antibodies (mAbs), as it often provides unique selectivity unmatched by traditional ion exchange or hydrophobic interaction chromatography. An increasing number of non-antibody proteins are entering today’s development pipeline. These new constructs pose purification challenges, since they are not amenable to current platform schemes. The lack of an affinity capture option often leaves a heavy burden on each step in downstream processing. In this workshop, we will illustrate the interactions between the protein molecules and mixed-mode resins in detail. We will also discuss working strategies for robust method development and optimization. The advantages of using these chromatography resins will be demonstrated by case study examples, which include efficient capture of target protein from expression culture, the removal of process impurities, and the separation of closely related species, such as product degradation fragments and high molecular weight aggregates. In summary we will discuss: interactions between protein molecules and mixed-mode resins; development of chromatographic methods; and case studies on the removal of process- and product- related impurities.

12:45-2:00 PM Re-evaluation of the CIP Step in Insulin-related RP HPLC Processes,

sponsored by DAISO Fine Chem USA, Inc. Location: Commonwealth Hall A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of DAISO Fine Chem USA by Monday @ 10:50 AM Recombinant Human Insulin, Insulin analogs, and other diabetes targeting drugs such as GLP-1 are the most important applications for industrial scale silica-based Reversed Phase High Pressure Liquid Chromatography (RP HPLC). Unfortunately, because these molecules are prone to self-aggregation and fibrillation, the columns get blocked by the inexorably forming protein goo-layer. To extend to lifetime of the column, a cleaning in place (CIP) protocol by washing the silica stationary phase with a pH 13 NaOH solution is the "necessary evil." This routinely performed CIP step has not been thoroughly calibrated: Are the current CIP protocols adequate? Is the concentration too harsh? Too mild? This presentation reports the first steps where a silica manufacturer can assist on the way to finding the answers by scientific evaluation. Simple tests will be shown that can be performed to check how adequate the CIP is with unique tools routinely used in silica manufacturing QC. Real life examples will also be presented.


Free Vendor Workshops Tuesday, July 18, 2016

Must pre-register at the sponsor's booth to attend; light lunch will be provided

12:45-2:00 PM Latest Developments of Stationary Phases for Preparative Chromatography,

sponsored by AkzoNobel/Kromasil Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of AkzoNobel/Kromasil by Monday @ 5:00 PM During this workshop we will share the latest developments of Kromasil materials including EternityXT, a stationary phase with organo silane merged into the base silica matrix. The high chemical and mechanical stability of EternityXT as well as its availability in bulk and pre-packed columns, makes it possible for users to run under tough pH conditions and higher temperatures across the various stages of product development including discovery, pilot plant and manufacturing in the pharmaceutical, biotech and natural product sectors. Kromasil EternityXT resistance to high alkaline concentrations for in-place regeneration as well as examples of typical applications will be presented.

12:45-2:00 PM Enabling Custom Solutions for Downstream Processing for Future Therapies, sponsored by Thermo Fisher Scientific

Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of Thermo Fisher Scientific by Monday @ 5:00 PM Presenter: Orjana Terova, Purification Product Manager Innovative purification resins have been developed through the POROS™ custom resin program and CaptureSelect™ ligand technology in close collaboration with our customers for manufacture of novel molecules, including mRNA and viral vectors, for which there was no standard purification strategy. This combination of our core competencies in ligand and resin development has allowed for development of platform purification processes that increase productivity and improve product yield. In this presentation the approach of developing enabling custom solutions for downstream processing will be discussed. The emphasis will be on prototype development, optimization of immobilization chemistry, ligand density and bead morphology leading to successful commercialization.

12:45-2:00 PM Bioseparation Media by Mitsubishi Chemical,

sponsored by Itochu Chemicals America/Mitsubishi Chemical Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Itochu Chemicals America by Monday @ 5:00 PM Mitsubishi Chemical Corporation has manufactured industrial separation media for the pharmaceutical and food industries for more than >50 years. The various products are used for chromatographic separation of peptides and small molecules like API to large molecules like proteins. Our newest products, MabSpeed™ (protein A) and ChromSpeed™ (ion exchange) are specially designed for purification of biopharmaceuticals (antibody-drugs, protein-drugs, etc.) as well as large oligonucleotides. This purpose of this workshop is to introduce these products designed for high throughput processing.

12:45-2:00 PM Affinity Chromatography—Protein A Improvements and Beyond,

sponsored by GE Healthcare Life Sciences Location: Tubman Room, 3rd floor (light lunch will be provided) Must pre-register at the booth of Itochu Chemicals America by Monday @ 5:00 PM Protein A-based chromatography is the primary method used to purify monoclonal antibodies (mAbs). Over the past decade, there has been a significant development of protein A media, resulting in both higher capacity and improved stability to meet the changing requirements of the industry, and more improvements are to come. However, the evolution of affinity chromatography is not limited to protein A. This talk will cover multiple examples and case studies including affinity chromatography media and discuss the drivers for cost-efficient affinity chromatography steps.


Sunday, July 17, 2016 9:00 AM - 12:30 PM Workshop 1 on Fundamentals of Preparative Chromatography for Commonwealth A1 Biomolecule Purification by Batch and Continuous Processes

See details and pricing at PREPsymposium.org. Open to conference and non-conference participants. Must pre-register to attend.

12:30 PM - 4:00 PM Workshop 2 on Fundamentals of Preparative Chromatography for Commonwealth A2 Purification of APIs, Peptides, and Oligonucleotides by Batch

Chromatography, SMB, and SFC See details and pricing at PREPsymposium.org. Open to conference and non-conference participants. Must pre-register to attend.

4:00 PM - 6:30 PM Workshop 3 on Regulatory Fundamentals, QbD, and Design of Commonwealth A1 Experiments for Biopharmaceuticals


1:30 - 5:30 PM Exhibitor Registration Only -- badge required to set up booth

6:00 - 7:30 PM Symposium Registration Open for Conferees

Location: Commonwealth Hall Foyer, 2nd floor

6:00 - 7:30 PM Grand Opening of the Exhibition & Welcome Reception Location: Millennium Hall, 2nd floor Open to all conference participants; conference name badge is required for entry.





Monday, July 18, 2016 7:00 AM - 8:30 AM Tutorial on Tips, Tricks, and Troubleshooting Analytical and Commonwealth A1 Overloaded Prep Chromatography


7:45 AM - 5:15 PM Symposium Registration Open


10:00 AM - 5:15 PM Exhibition Open in Millennium Hall, 2nd floor

8:30 AM WELCOME AND OPENING REMARKS Giorgio Carta, University of Virginia, Charlottesville, VA, USA

Location: Commonwealth Hall C/D, 2nd floor

1. Monday Keynote: Industrial Case Studies in Protein Chromatography Session Chairs: Giorgio Carta, University of Virginia, Alan Hunter, MedImmune, Gaithersburg, MD, USA Location: Commonwealth Hall C/D, 2nd floor

8:40 AM (L-101) Development of a Semi-continuous, Integrated Chromatography

Purification Platform for Perfusion and High Titer Fed Batch Antibody Production. Rebecca Chmielowski, Darshini Shah, Collette Cutler, Hong Li, David Roush, Nihal Tugcu, Merck, Kenilworth, NJ, USA

9:00 AM (L-102) Mechanistic Investigation of Aggregate Formation in CEX and Mitigation

Strategy for an Unstable Fc-fusion Protein. Zhiqiang Chen, Chao Huang, Naresh Chennamsetty, Xuankuo Xu, ZhengJian Li, Bristol-Myers Squibb, Devens, MA, USA

9:20 AM (L-103) A New Approach to Assess the Process Clearance Capability for Critical

Quality Attributes. Kathlyn Lazzareschi, Josefine Persson, Genentech A member of Roche, South San Francisco, CA, USA

9:40 AM (L-104) High Resolution Preparative Protein Separation using Novel pH Gradients

Employing Simple Buffer Systems. Matthew Herigstad, Lihua Yang, Natarajan Ramasubramanyan, AbbVie, Westborough, MA, USA

10:00 AM (L-105) Purification of Recombinant Polyclonal Antibody (rpAb) Mixtures: Impact

of Polishing Modality on Aggregate Selectivity and mAb Component Ratios. Alan Hunter, Frank Bartnik, Hongji Liu, Xiangyang Wang, Timothy Pabst, MedImmune, Gaithersburg, MD, USA

10:20-10:50 AM Break in Millennium Exhibit Hall



Monday, July 18, 2016

2. Monday Keynote: Continuous Chromatography Session Chairs: Kathleen Mihlbachler, LEWA Process Technologies, Devens, MA, USA, Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA Location: Commonwealth Hall C/D, 2nd floor

10:50 AM (L-106) Continuous Multicolumn Purification of Therapeutic Proteins.

Fabian Steinebach, Daniel Baur, Nicole Ulmer, Lara Decker, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND

11:10 AM (L-107) Continuous Purification Platforms for Viral Vectors based on Multicolumn

Simulated Countercurrent Chromatography. Ricardo Silva1, Cristina Peixoto

1, Manuel

Carrondo1, Jose Mota

2,

1IBET, Oeiras, PORTUGAL;

2FCT-UNL & IBET, Caparica,

PORTUGAL 11:30 AM (L-108) Model-based Conversion of a Single-column Batch Process to 3- and 4-

Column Periodic Counter-current Chromatography. Tobias Hahn, Thiemo Huuk, Fabian Gorlich, Gang Wang, Jurgen Hubbuch, KIT, Karlsruhe, GERMANY

11:50 AM (L-109) Model Predictive Control of 4-zone Simulated Moving Bed Chromatography

using a Decoupled and Simplified Process Model. Ju Weon Lee, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY

12:10-12:30 PM (L-110) A Rationale Approach for Comparing Different Affinity Chromatographic

Processes for the Capture of a Monoclonal Antibody. Roger-Marc Nicoud1, Laurent

David1, Margit Holzer

1, Jay Yun

2,

1Ypso-Facto, Nancy, FRANCE;

2Ypso-Facto,

Cambridge, MA, USA

Monday Mixer in the Exhibition Hall Location: Millennium Hall, 2nd floor - Mixer includes light lunch

12:30-3:20 PM Break, Exhibits, Posters

Monday Free Vendor Workshops Must pre-register at the sponsor's booth to attend; light lunch will be provided

12:45-2:00 PM A Bead for Every Need, from MAb Purification to Uranium Extraction,

sponsored by Purolite Life Sciences Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Purolite Life Sciences by Monday @ 10:50 AM

12:45-2:00 PM Utilizing Novel Mixed-Mode Selectivities for Challenging Chromatography

Separations, sponsored by Bio-Rad Laboratories Location: Commonwealth Hall A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of Bio-Rad Laboratories by Monday @ 10:50 AM

12:45-2:00 PM Re-evaluation of the CIP Step in Insulin-related RP HPLC Processes,

sponsored by DAISO Fine Chem USA, Inc. Location: Commonwealth Hall A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of DAISO Fine Chem USA by Monday @ 10:50 AM



MONDAY POSTER SESSION 1 Poster Session Chair: Dorota Antos, Rzeszow University of Technology, Poland Location: Millennium Exhibition Hall, 2nd floor

2:00-3:15 PM POSTER SESSION 1 - Sponsored by Bristol-Myers Squibb

Location: Millennium Exhibit Hall

3A. Monday Parallel Session: Strategies and Processes for Biomolecule Purification Session Chair: Abraham Lenhoff, University of Delaware, Newark, DE, USA Location: Commonwealth Hall C/D, 2nd floor

3:20 PM (L-111) Purification of Secretory Immunoglobulins by Chromatographic Methods.

Hannah Engelmaier, Alexander Matlschweiger, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA

3:40 PM (L-112) Resolution of Positional Isomers of Exenatide Mono-PEGylates by Prep

Chromatography. Thi Ngoc Thanh Nguyen, Soi Yoon, E. K. Lee, Hanyang University, Ansan, SOUTH KOREA

4:00 PM (L-113) Heat Precipitation of Tobacco Host Cell Proteins Facilitates Target Protein

Recovery and Purification and Can be Implemented into an Automated Large-scale Manufacturing Process. Stephan Menzel, Rainer Fischer, Johannes Buyel, Fraunhofer IME, Aachen, GERMANY

4:20 PM (L-114) Optimizing Recombinant F(ab)2 Purification for Improved PET Imaging of

Cancer Biomarkers. Mark Fitchmun1, Kimberly Fitchmun

1, Ritsuko Sawada

2, Wolfgang

Scholz2,

1Somatek Inc., San Diego, CA, USA;

2MabVax Therapeutics, San Diego, CA,

USA

4:40-5:10 PM Break in Millennium Exhibit Hall



3B. Monday Parallel Session: Stationary Phases 1 Session Chairs: Shuichi Yamamoto, Yamaguchi University, Japan and Conan Fee, Canterbury University, New Zealand Location: Commonwealth Hall B, 2nd floor

3:20 PM (L-115) High Performance, Rapid Separation, and High Loading Capacity of the

Novel Stationary Phase using Dual-pore Silica Beads in Reversed Phase Liquid Chromatography. Hong-zhi Bai

1, Riichi Miyamoto

1, Akie Kawamura

2, Mika Watanabe

2,

Teruhiko Kanno2, Takashi Ohtani

2, Kazuki Nakanishi

3,

1SnG Inc., Kyoto, JAPAN;

2Hamari

Chemicals Ltd., Osaka, JAPAN; 3Kyoto University, Kyoto, JAPAN

3:40 PM (L-116) Design and Evaluation of Advanced Amsphere™ A3 Protein A

Chromatography Resin: The Relationships and Considerations of Bead structure, Pore Structure, Surface Chemistries and Ligand Design on Affinity Resin Performance Targets. Satoshi Nakamura

1, Alpana Naresh

2, Tomonori Shiotani

1, Marty

Siwak2,

1JSR Micro, Durham, NC, USA;

2JSR Micro, Sunnyvale, CA, USA

4:00 PM (L-117) Reducing Cost of Clinical Trials through the use of Novel Alkali Stable

Protein A Resins. Hans Berg1, Mark Hicks

2, Caroline Tinsley

2, Patrick Gilbert

2, Charlotte

Vassay-Jones2, Hans J. Johansson

1,

1Purolite, Uppsala, SWEDEN;

2Purolite, Llantrisant,

WALES 4:20 PM (L-118) Single and Multi-component IgG Adsorption on Protein A Chromatography

Resins. Justin Weinberg1, Shaojie Zhang

2, Giorgio Carta

2, Todd Przybycien

1,

1Carnegie

Mellon University, Pittsburgh, PA, USA; 2University of Virginia, Charlottesville, VA, USA

4:40-5:10 PM Break in Millennium Exhibit Hall

4A. Monday Parallel Session: Monoliths and Membrane Chromatography Session Chair: Ales Podgornik, COBIK, Ljubljana, Slovenia Location: Commonwealth Hall C/D, 2nd floor

5:10 PM (L-119) Evaluation of Ligand Design for Downstream Processes: Impacts of Ligand

Structure on Ion-exchange Membrane Performance. Jerry Rasmussen, Cathy Bothof, Semra Colak Atan, Robert Fitzsimons, George Griesgraber, Federica Sgolastra, Andrew Vail, 3M, St. Paul, MN, USA

5:30 PM (L-120) Rapid Protein Ion-exchange Separations using Surface Modified Nylon

Capillary-channeled Polymer (C-CP) Fibers. Liuwei Jiang, R. Kenneth Marcus, Clemson University, Clemson, SC, USA

5:50 PM (L-121) Optimization of Continuous Countercurrent Tangential Chromatography

(CCTC) for Continuous Purification of Monoclonal Antibodies. Oleg Shinkazh1,

Andrew Zydney2,

1ChromaTan, State College, PA, USA;

2Penn State University, State

College, PA, USA 6:10 PM Pause



4B. Monday Parallel Session: Stationary Phases 2 Session Chairs: Shuichi Yamamoto, Yamaguchi University, Japan and Conan Fee, Canterbury University, New Zealand Location: Commonwealth Hall B, 2nd floor

5:10 PM (L-122) Mixed Mode Chromatography in Non-affinity based Purification Schemes.

Carsten Voss, Bio-Rad Laboratories GmbH, Munich, GERMANY 5:30 PM (L-123) Narrow-dispersion Hydrophobic Interaction Chromatographic Media for

mAb and ADC Separation with High Resolution. Sixi Wang, Ke Yang, Xueying Huang, Sepax Technologies, Newark, DE, USA

5:50 PM (L-124) Dual Flow Chromatography for Parallel, Automated, High Throughput

Process Development. Douglas Gjerde, Christopher Suh, Lee Hoang, PhyNexus Inc., San Jose, CA, USA

6:10 PM Pause

Tuesday, July 19, 2016

7:30 AM - 5:15 PM Symposium Registration Open


9:00 AM - 3:30 PM Exhibition Open in Millennium Hall, 2nd floor

5. Tuesday Keynote: Preparative Chromatography in Drug Discovery, Development, and Manufacture Session Chair: Tony Yan, Pfizer, Groton, CT, USA Location: Commonwealth Hall C/D, 2nd floor

8:00 AM (L-201) Liquid Carbon Dioxide Flash: Has the Myth Become Reality.

Ray McClain, Merck, West Point, PA, USA 8:20 AM (L-202) Design (and Avoidance) of Process-scale Chromatography through the use

of Statistical Design of Experiments. Teri Hochdorfer, Fangfang Liu, Ke Wang, Glenn Wilcox, Pfizer, Groton, CT, USA

8:40 AM (L-203) Dual Purpose Analytical SFC/UHPLC Instrument with On-line SFE

Capability for Automated Method Screening of Chiral and Achiral Separations. Robert Buco

1, Masayuki Nishimura

2, Yosuke Iwata

3, Kenichiro Tanaka

4,

1Shimadzu

Corporation, Marlborough, MA, USA; 2Shimadzu Corporation, Columbia, MD, USA;

3Shimadzu Corporation, Kyoto, JAPAN;

4Shimadzu Scientific Instruments Inc., Columbia,

MD, USA 9:00 AM (L-204) Chromatography as the Multi-tool of Drug Development and its Preparative

Chiral Attachment. J. Preston, Michael McCoy, Phenomenex, Torrance, CA, USA

9:20-9:50 AM Break in Millennium Exhibit Hall



6. Tuesday Session: Understanding and Modeling Biomolecule Chromatography Session Chair: David Roush, Merck & Co., Inc., Kenilworth, NJ, USA Location: Commonwealth Hall C/D, 2nd floor

9:50 AM (L-205) Molecular Modeling Technique for Protein-surface Binding Free Energy

Calculation and Prediction of Elution Behavior in Multimodal Chromatography. Suvrajit Banerjee, Shekhar Garde, Steven Cramer, Rensselaer Polytechnic Institute, Troy, NY, USA

10:10 AM (L-206) Probing Nanoscale Effects of Ligand Density in Tentacular Ion Exchangers

using X-ray Scattering. Rahul Bhambure1, Daniel Greene

1, Yun Liu

1, Christopher

Gillespie2, Michael Phillips

2, Heiner Graalfs

3, Almut Rapp

3, Abraham Lenhoff

1,

1University

of Delaware, Newark, DE, USA; 2MilliporeSigma, Bedford, MA, USA;

3Merck Millipore,

Darmstadt, GERMANY 10:30 AM (L-207) Effect of Isotherm Nonlinearity on Protein Binding and Elution in

Hydrophobic Interaction and Multimodal Chromatography. Renata Muca, Wojciech Piątkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND

10:50 AM (L-208) Influence of Mixed Electrolytes and pH on Adsorption of Proteins in

Hydrophobic Interaction Chromatography. Eva Hackemann, Hans Hasse, University of Kaiserslautern, Kaiserslautern, GERMANY

7. Tuesday Session: Innovative Materials and Processes for Biochromatography Session Chair: Kathlyn Lazzareschi, Genentech, South San Francisco, CA, USA Location: Commonwealth Hall C/D, 2nd floor

11:10 AM (L-209) Fluid Dynamics Simulation based on 3D pore Structure of Macro Porous

Monoliths Shows High Permeability Due to Alternating Channel Width. Alois Jungbauer

1, Christian Jungreuthmayer

2, Petra Gerster

1,

1BOKU, Vienna, AUSTRIA;

2acib, Vienna, AUSTRIA

11:30 AM (L-210) Optimization of Porous Bed Geometric Features to Maximize Adsorption of

Proteins and Passage of Suspended Solids in a 3D-printed Adsorption Column. Conan Fee

1, Felix Newberry

1, Anne Gordon

1, Philip Wilson

1, Miguel Moyers-Gonzalez

1,

Rua Murray1, Tim Huber

1, Simone Dimartino

2,

1University of Canterbury, Christchurch,

NEW ZEALAND; 2University of Edinburgh, Edinburgh, SCOTLAND

11:50 AM (L-211) A Scaleable Integrated System for Temperature-controlled Fast Protein

Liquid Chromatography. Owen R.T. Thomas1, Eirini Theodosiou

2, Matthias Franzreb

3,

1University of Birmingham, Birmingham, UK;

2Aston University, Birmingham, UK;

3Karlsruhe Institute of Technology, Eggenstein-Leopoldshafen, GERMANY

12:10-12:30 PM (L-212) Modeling of Linear pH and Salt Gradient Elution on Weak Cation Exchange

Resins. Felix Wittkopp, Christian Frech, University of Applied Sciences, Mannheim, GERMANY



Tuesday Mixer in the Exhibition Hall Location: Millennium Hall, 2nd floor -- Mixer includes light lunch

12:30-3:20 PM Break, Exhibits, Posters

Tuesday Free Vendor Workshops Must pre-register at the sponsor's booth to attend; light lunch will be provided

12:45-2:00 PM Latest Developments of Stationary Phases for Preparative Chromatography,

sponsored by AkzoNobel/Kromasil Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of AkzoNobel/Kromasil by Monday @ 5:00 PM

12:45-2:00 PM Enabling Custom Solutions for Downstream Processing for Future Therapies, sponsored by Thermo Fisher Scientific

Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of Thermo Fisher Scientific by Monday @ 5:00 PM

12:45-2:00 PM Bioseparation Media by Mitsubishi Chemical,

sponsored by Itochu Chemicals America/Mitsubishi Chemical Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Itochu Chemicals America by Monday @ 5:00 PM

12:45-2:00 PM Affinity Chromatography—Protein A Improvements and Beyond,

sponsored by GE Healthcare Life Sciences Location: Tubman Room, 3rd floor (light lunch will be provided) Must pre-register at the booth of Itochu Chemicals America by Monday @ 5:00 PM

TUESDAY POSTER SESSION 2 Poster Session Chair: Dorota Antos, Rzeszow University of Technology, Poland Location: Millennium Exhibition Hall, 2nd floor

2:00-3:15 PM POSTER SESSION 2 - Sponsored by Bristol-Myers Squibb

Location: Millennium Exhibit Hall



8A. Tuesday Parallel Session: New Developments in Affinity Chromatography Session Chair: Rainer Hahn, BOKU, Vienna, Austria Location: Commonwealth Hall C/D, 2nd floor

3:20 PM (L-213) Making Protein A Media Stealthy. Todd Przybycien, Justin Weinberg, Carnegie

Mellon University, Pittsburgh, PA, USA 3:40 PM (L-214) Evaluation of Protein A Resin Degradation in a Multi-column

Chromatography Process through Process Modeling and Resin Lifetime Study. Ketki Behere, Seongkyu Yoon, University of Massachusetts Lowell, Lowell, MA, USA

4:00 PM (L-215) A Platform for the Development of Affinity Peptide Resins for Capture and

Downstream Purification of Non-mAb Biologics. Divya Chandra, Steve Timmick, Chaz Goodwine, Nick Vecchiarello, Pankaj Karande, Steven Cramer, Chemical & Biological Engineering Rensselaer Polytechnic Institute, Troy, NY, USA

4:20-4:40 PM (L-216) Development of a Continuous Protein A Capture Unit Operation: How

Resin Characteristics Change the Multi-column Process. Nicolas-Julian Hilbold1,

Xavier Le Saout2, Eric Valery

3, Jonathan Souquet

2, Laurence Muhr

4,

1Novasep, Pompey,

FRANCE; 2Merck KGaA, Corsier-sur-Vevey, SWITZERLAND;

3Novasep, Lyon, FRANCE;

4LRGP (Reactions and Process Engineering Laboratory), Nancy, FRANCE

8B. Tuesday Parallel Session: New Developments and Applications of Continuous Chromatography Session Chair: Attila Felinger, University of Pecs, Hungary Location: Commonwealth Hall B, 2nd floor

3:20 PM (L-217) Demonstration of a mAb Chromatography Platform Process Operating in a

Continuous and Integrated Mode: Flexibility for Facility Fit and Process Economics Optimization. Xhorxhi Gjoka, Rene Gantier, Mark Schofield, Pall Life Sciences, Westborough, MA, USA

3:40 PM (L-218) Separation of Astaxanthin from the Crude Extract of Haematococcus

Pluvialis by Simulated Moving Bed. Xiao-Qing Bao, Wen-Tung Wu, Chih-Hsiung Lin, Ya-Ting Shih, Ming-Tsai Liang, I-Shou University, Kaohsiung, TAIWAN

4:00 PM (L-219) Large Scale (Ton Scale) Purification of Plant Derived Proteins using

Simulated Moving Bed Chromatography. Anil Oroskar, Pravin Ninanwe, Babu Antharawalli, Priyanka Oroskar, Orochem Technologies Inc., Naperville, IL, USA

4:20-4:40 PM (L-220) An Integrated UV-VIS Detection Module for MCC in Achiral Separations.

Gary Yanik1, Leo Hsu

2, Xiqin Yang

2,

1PDR-Separations, Palm Beach Gardens, FL, USA;

2GlaxoSmithKline, King of Prussia, PA, USA



9A. Tuesday Parallel Session: Column Characterization Session Chair: Igor Quinones-Garcia, Shire, Lexington, MA, USA Location: Commonwealth Hall C/D, 2nd floor

4:50 PM (L-221) Measurement and Modelling of Extra Column Volume and System Band

Broadening for Scale-up of Preparative Chromatography Columns. Susanne Schweiger

1, Christian Jungreuthmayer

1, Tim Schröder

2, Alois Jungbauer

3,

1Austrian

Centre of Industrial Biotechnology, Vienna, AUSTRIA; 2Atoll GmbH, Weingarten,

GERMANY; 3University of Natural Resources and Life Sciences, Vienna, AUSTRIA

5:10 PM (L-222) Characterization and Application of Microliter Disposable Monolithic

Columns (DMC)for PAT. Tanja Lukan1, Shuichi Yamamoto

2, Noriko Yoshimoto

3, Ales

Podgornik1,

1 COBIK, Ljubljana, SLOVENIA; 2Yamaguchi University, Ube, JAPAN;

3Ube,

JAPAN 5:30 PM (L-223) Chromatographic Column Transition Analysis using Moment Analysis.

Brian Youchak1, Willis Bell

2,

1Eli Lilly and Company, Branchburg, NJ, USA;

2Eli Lilly and

Company, Indianapolis, IN, USA 5:50 PM (L-224) Planning the Execution of a Viral Clearance Study: Right First Time.

Douglas Rea, Katherine Bergmann, Eurofins Lancaster Labs, Lancaster, PA, USA

6:10 PM Pause

9B. Tuesday Parallel Session: Advances in Chromatographic Modalities for Bioprocess Applications Session Chair: Christian Frech, Mannheim University of Applied Sciences, Germany Location: Commonwealth Hall A, 2nd floor

4:50 PM (L-225) Flow Through Chromatography and Absorptive Depth Filtration for

Continuous Bioprocessing Applications – Case Studies. Romas Skudas, Paul Beckett, Merck KGaA, Darmstadt, GERMANY

5:10 PM (L-226) SMART Chromatography - A Method for Packed Bed Purification from Cell

Containing Feedstreams. Alistair Hurst, Derek Levison, Ruediger Welz, Franziska Meier-Haettig, emp Biotech GmbH, Berlin, GERMANY

5:30 PM (L-227) Purification of Acidic Proteins with Ceramic Hydroxyapatite: Bind-and-

Elute Mode or Flow-through Mode? Xuemei He, Louisa Vang, Bio-Rad Laboratories, Hercules, CA, USA

5:50 PM (L-228) Bridging the Gap Between Analytical and Process Protein A

Chromatography. J. Kevin O'Donnell1, Atis Chakrabarti

1, William Evans

1, Kosuke Araki

2,

Shigeru Nakatani2,

1Tosoh Bioscience LLC, King of Prussia, PA, USA;

2Tosoh

Corporation, Shunan, JAPAN

6:10 PM Pause


Wednesday, July 20, 2016

7:30 AM Symposium Registration Open

10. Wednesday Keynote: Preparative Supercritical Fluid Chromatography (SFC) Session Chairs: Lois Beaver, LAB Enterprises, Chevy Chase, MD, USA and Jonathan Edelman, Washington Chromatography Discussion Group Location: Commonwealth Hall A/B, 2nd floor

8:00 AM (L-301) Operating Large Diameter Columns in Liquid and Supercritical Fluid

Chromatography under Strictly Adiabatic Thermal Environment. Fabrice Gritti, Joseph Jarrell, Martin Gilar, Waters Corporation, Milford, MA, USA

8:20 AM (L-302) Stationary Phase Selection for Optimized Preparative SFC

Chromatography. Matthew Przybyciel, ES Industries, West Berlin, NJ, USA 8:40 AM (L-303) Advances in Preparative Gas-expanded Liquid Chromatography.

Jerome Boni1, Celine Morey

1, Jin Seok Hur

2, Yvan Ruland

3,

1Novasep, Pompey,

FRANCE; 2Novasep, Boothwyn, PA, USA;

3Novasep, Shanghai, CHINA

9:00 AM (L-304) Reliable Scale-up from Linear Gradient Screening to Isocratic Bulk-

purification in SFC. Jason Hill, Abhijit Tarafder, Waters, Milford, MA, USA 9:20-9:40 AM (L-305) Peak Distortions in Supercritical Fluid Chromatography due to Adsorption

of the Co-solvent. Torgny Fornstedt1, Emelie Glenne

1, Jörgen Samuelsson

1, Hanna

Leek2, Kristina Ohlen

2, Magnus Klarqvist

2,

1Karlstad University, Karlstad, SWEDEN;

2AstraZeneca R&D Molndal, Molndal, Sweden

11. Wednesday Keynote: Preparative Purification of Peptides Session Chairs: Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA, Marc Jacob, Phenomenex, Torrance, CA, USA Location: Commonwealth Hall A/B, 2nd floor

9:40 AM (L-306) State-of-the-Art Purification of Peptide APIs: Challenges and

Achievements. Georg M. Sambeth1, Günther Loidl

2, Ralph Schönleber

1,

1Bachem AG,

Bubendorf, SWITZERLAND; 2Bachem Holding, Bubendorf, SWITZERLAND

10:00 AM (L-307) Chemically Stable Merged Organic/Inorganic Silica Material for

Purifications of Peptides and Proteins in Reversed Phase Preparative Chromatography. Fredrik Lime, Cecilia Mazza, AkzoNobel/Kromasil, Bohus, SWEDEN

10:20 AM (L-308) Influence of Column Overloading on Selectivity in Peptide Purification.

Guido Krautz1, Tivadar Farkas

2, Marc Jacob

2,

1Phenomenex Ltd., Aschaffenburg,

GERMANY; 2Phenomenex Inc., Torrance, CA, USA

10:40-11:10 AM Break in Commonwealth Foyer



12. Wednesday Session: Chromatography for Virus Particles Session Chair: Alois Jungbauer, BOKU, Vienna, Austria Location: Commonwealth Hall A/B, 2nd floor

11:10 AM (L-309) Combining Solute Surface Analytics and High Throughput Screening to

Define Binding Mechanisms of Virus Particles to Multimodal Anion Exchange Resin. Matthew Brown

1, Sarah Johnson

1, Kurt Brorson

1, Scott Lute

1, David Roush

2,

Joseph Hughes3, Mike Burnham

3,

1US Food and Drug Administration, Silver Spring, MD,

USA; 2Merck, Kenilworth, NJ, USA;

3WuXi Apptec, Philadelphia, PA, USA

11:30 AM (L-310) Positive and Negative Mode Multi-column Processes for Enveloped Virus-

like Particles Purification. Ricardo Silva1, Alex Xenopoulos

2, Paula Alves

3, Manuel

Carrondo4, Cristina Peixoto

3,

1iBET, Oeiras, PORTUGAL;

2EMD Millipore, Bedford, MA,

USA; 3iBET/ITQB, Oeiras, PORTUGAL;

4iBET/FCT-UNL, Oeiras, PORTUGAL

11:50 AM (L-311) Purification of Cell Culture-based Influenza Virus Particles using

Membrane Filters with the Aid of Non-ionic Polymers. Pavel Marichal-Gallardo1,

Michael Martin Pieler1, Michael Wolff

2, Udo Reichl

2,

1Max Planck Institute for Dynamics of

Complex Technical Systems, Magdeburg, GERMANY; 2Max Planck Institute for

Dynamics of Complex Technical Systems & Chair of Bioprocess Engineering at Otto von Guericke University Magdeburg, Magdeburg, GERMANY

12:10 PM (L-312) The Assembly Phase of Virus-Like Particles Contributes Significantly to

Separation and Purification. Mike Zhang, Frank Gillam, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

12:30-12:40 PM Presentation of Awards to Winners of the Best Poster Competition 12:40-1:40 PM Lunch on own

13. Wednesday Session: Chromatography Fundamentals Session Chair: Jose Mota, IBET, Portugal Location: Commonwealth Hall A/B, 2nd floor

1:40 PM (L-313) Experimental and Theoretical Analysis of Chromatographic Processes in

the Presence of Liquid-liquid Phase Separation. Franziska Ortner, Marco Mazzotti, ETH Zurich, Zurich, SWITZERLAND

2:00 PM (L-314) The Loadability and Retention Behavior of Zwitterionic Stationary Phases.

Attila Felinger, University of Pecs, Pecs, HUNGARY 2:20 PM (L-315) Improving the Productivity of Capture Chromatography based on a

Simplified Mechanistic Model. Noriko Yoshimoto, Sumiko Hasegawa, Shuichi Yamamoto, Yamaguchi University, Ube, JAPAN

2:40 PM (L-316) Robust Multi-objective Optimization of Chromatographic Rare Earth

Element Separation. Hans-Kristian Knutson, Anders Holmqvist, Bernt Nilsson, Lund University, Lund, SWEDEN

3:00 PM (L-317) A Concurrent Approach for Isotherm Determination and Design of

Simulated Moving Bed Process for Multicomponent Systems. Pranav Vengsarkar, Siwei Guo, Jason Bentley, Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA



14. Wednesday Session: Advances in CPC, CCC, and Chiral Separations Session Chair: Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA Location: Commonwealth Hall A/B, 2nd floor

3:20 PM (L-318) How Can Ion-pair CPC Make Joke of RPC at Preparative Levels?

Laszlo Lorantfy1, Dora Rutterschmidt

1, Zsolt Kovacs

2, Ying Hou Guan

3, Laszlo Frici

Nemeth1,

1RotaChrom Technologiai, Dabas, HUNGARY;

2ELTE, Budapest, HUNGARY;

3BME, Budapest, HUNGARY

3:40 PM (L-319) Spiral Countercurrent Chromatography for Preparative Separations using

Aqueous Two-phase Solvent Systems. Rodrigo Lazo-Portugal1, Steingrimur

Stephansson2, Saeyoung Nate Ahn

2, Martha Knight

1,

1CC Biotech LLC, Rockville, MD,

USA; 2Fuzbien Technology Inst., Rockville, MD, USA

4:00 PM (L-320) Cost-effectiveness Modeling to Understand the Contribution of Preparative

Chiral Separations in Pharmaceutical R&D. Jeffrey Kiplinger, Paul Lefebvre, Emily Rouse, Keith Galyan, Averica Discovery, Marlborough, MA, USA

4:20-4:40 PM (L-321) Resolution of Mandelic Acid Enantiomers by Coupling Separation with

Enantioselective Chromatography and Enzymatic Racemization. Katarzyna Wrzosek, Katja Bettenbrock, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY

5:00 PM CLOSING REMARKS, Giorgio Carta, University of Virginia, Charlottesville, VA, USA 5:10 PM Farewell Reception


Monday Poster Session I Preliminary List of Presentations Posters in the P-100 series will be presented on Monday in Poster Session I @ 2:00 - 3:15 PM

Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See link to poster guidelines under Author Instructions at PREPsymposium.org

Click here to submit abstracts for online program by July 8th

P-M-101 Three Column Cyclic System for Protein Separation in Gradient Mode. Rafał

Gorczyca, Wojciech Marek, Roman Bochenek, Wojciech Piatkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND

P-M-102 PCR Based Cloning: A Fast, Cheap, and Easy Way to Customize Proteins at the

DNA Level. Imen Tanniche, Amanda Fisher, Ryan Senger, Mike Zhang, Frank Gillam, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

P-M-103 Flow Through Chromatography – A Powerful Purification Tool for Naked and

Enveloped Viruses. Ricardo Silva1, Alex Xenopoulos

2, Paula Alves

3, Manuel Carrondo

4,

Cristina Peixoto4,


2EMD Millipore, Bedford, MA, USA;

3iBET/ITQB, Oeiras, PORTUGAL;


P-M-104 An Empirical Design Approach of Multi-column Chromatographic Processes for

Enveloped Virus-like Particles Purification. Ricardo Silva1, Alex Xenopoulos

2, Paula

Alves3, Manuel Carrondo

4, Cristina Peixoto

3,


2EMD Millipore,

Bedford, MA, USA; 3iBET/ITQB, Oeiras, PORTUGAL;

4iBET/FCT-UNL, Oeiras,

PORTUGAL P-M-105 Ceramic Hydroxyapatite for the Polish Purification of an Acidic Recombinant

Enzyme CDP-D-Glucose 4, 6-Dehydratase. Louisa Vang, Xuemei He, Bio-Rad Laboratories, Hercules, CA, USA

P-M-106 Evaluation of a Novel Adsorptive Anion Exchange Hybrid Purifier for

Biopharmaceutical Harvest Clarification and Impurity Reduction. Michael McGarrah, Hiren Ardeshna, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-M-107 In silico Modeling of Cation Exchange Chromatography Gradient Elution on Model

Systems to Develop Practical Guidelines for Step Optimization. Chris Gerberich, Andre Dumetz, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-M-108 Modeling of Linear pH and Salt Gradient Elution on Weak Cation Exchange Resins.

Felix Wittkopp, Christian Frech, University of Applied Sciences, Mannheim, GERMANY P-M-109 Simplifying the Purification Process for PEGylated Erythropoietin by using a

Combined Experimental/Modeling Development Approach. Roberto Falkenstein, Bernhard Spensberger, Ferdinand Stueckler, Jan Griesbach, Markus Haberger, Michaela Hook, Wolfgang Koehnlein, Ulrich Schilhabel, Ulrike Strauss, Roche Diagnostics GmbH, Penzberg, GERMANY

P-M-110 Characterizing Diatomaceous Earth and its Capacity as an Adsorbent for Proteins.

Ohnmar Khanal1, Steven Traylor

2, Nripen Singh

2, Xuankuo Xu

2, Zheng Jian Li

2, Abraham

Lenhoff1,

1University of Delaware, Newark, DE, USA;

2Bristol-Myers Squibb, Devins, MA,

USA P-M-111 Adsorption Study of Cellulose based Cation IEX Resins. Miki Iwama, Yoshihiro

Matsumoto, Yasuto Umeda, Shigeyuki Aoyama, JNC Corporation, Tokyo, JAPAN

http://prepsymposium.org/poster-guidelines.html






P-M-112 Novel Protein L-based Chromatography Resin for Affinity Purification of

Antibodies and Antibody Fragments. Hidetaka Kobayashi, Kosuke Araki, Shigeru Nakatani, Tosoh Corporation, Shu-nan, JAPAN

P-M-113 Optimizing Recombinant F(ab)2 Purification for Improved PET Imaging of Cancer

Biomarkers. Mark Fitchmun1, Kimberly Fitchmun

1, Ritsuko Sawada

2, Wolfgang Scholz

2,

1Somatek Inc., San Diego, CA, USA;

2MabVax Therapeutics, San Diego, CA, USA

P-M-114 Enhancing the Power of HTPD with Empirical Interpolation Models to Predict pH

and Salt Gradient Elution Behavior at High Protein Loads. Arch Creasy1, Joseph

Calzada2, Gregory Barker

2, Sibylle Herzer

2, Leland Paul

2, Giorgio Carta

1,

1University of

Virginia, Charlottesville, VA, USA; 2Bristol-Myers Squibb, Bloomsbury, NJ, USA

P-M-115 Affinity Purification of Viral Vectors. Utilizing Antibody-based Specificity in the

Manufacturing Process of Viral Vectors for Gene and Cell Therapies. Pim Hermans1,

Bruce Dawson2,

1Thermo Fisher Scientific, Leiden, THE NETHERLANDS;

2Thermo

Fisher Scientific, Wilmington, NC, USA

P-M-116 Characterizing Protein Adsorption in Polymer-Derivatized Chromatographic Media using Small-Angle Neutron Scattering. Stijn H. S. Koshari, Norman J. Wagner, Abraham M. Lenhoff, University of Delaware, Newark, DE, USA

P-M-117 Development and Implications of Single Pass TFF Prior to Capture

Chromatography. Ben Kester, Cook Pharmica, Bloomington, IN, USA P-M-118 Multi-Column Continuous Chromatography for Protein A Capture and Orthogonal

Polishing of Monoclonal Antibodies. Anthony Grabski, Tom Van Oosbree, Beth Hammer, Robert Mierendorf, Semba Biosciences, Inc., Madison, WI, USA

P-M-119 EcoPrime Twin – Continuous Two-Column Chromatography at the Process Scale.

Kathleen Mihlbachler, LEWA Process Technologies, Devens, MA, USA

P-M-120 Purification of Secretory Immunoglobulins by Chromatographic Methods. Hannah

Engelmaier, Alexander Matlschweiger, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA

P-M-121 High Pressure Homogenization: Impact of Operating Conditions on Further

Downstream Processing. Christopher Zartler, Bernhard Sissolak, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA

P-M-122 PuroPhase SPE Reverse Phase - A New Complete Platform for SPE. Christopher

Bresner1, Ksenia Sochilina

2, Alessandra Basso

1,

1Purolite, Llantrisant, UK;

2Purolite,

Moscow, RUSSIA

P-M-123 Experimental Validation of Relay Simulated Moving-bed Chromatography. Jose Mota

1, Ricardo Silva

2,

1LAQV/REQUIMTE & IBET, Caparica, PORTUGAL;

2IBET,

Oeiras, PORTUGAL P-M-124 Application of Spiral Countercurrent Chromatography to Natural Product

Separation. Cuiping Chen1, William Folk

2, Thomas Finn

1, Martha Knight

1,

1CC Biotech

LLC, Rockville, MD, USA; 2University of Missouri, Rolla, MO, USA







P-M-125 Extractive Sample Introduction in Preparative Supercritical Fluid Chromatography.

Geoffrey Cox1, Mohamed Shaimi

2,

1PIC Solution Inc., Media, PA, USA;

2PIC Solution

SAS, Avignon, FRANCE P-M-126 Robust Multi-objective Optimization of Chromatographic Rare Earth Element

Separation. Hans-Kristian Knutson, Anders Holmqvist, Bernt Nilsson, Lund University, Lund, SWEDEN

P-M-127 Harmonizing a Workflow in a Variable Chemical Space to Enable High Throughput

Purification. Greg Ciszewski, Justin Bellenger, Khunte Bhagyashree, Patrick Mullins, Pfizer, Groton, CT, USA

P-M-128 Dual Flow Chromatography for Automated Process Development. Carrie Huynh,

Douglas Gjerde, PhyNexus, San Jose, CA, USA P-M-129 Generalized Perturbation Method to Determine Multicomponent Isotherm for

Saturated Systems. Siwei Guo, Pranav Vengsarkar, Jason Bentley, Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA

P-M-130 A Preparative Liquid Chromatograph Equipped with On-Line Fraction Trapping and

On-Column Washing Technology Realizes Recovering of Target Compounds with High Purity in Short Time. Tomoyuki Yamazaki

1, Tsutomu Okoba

1, Saki Yoshino

1, Ei-

ichi Matsuo1, Yoshihiro Hayakawa

1, Yosuke Iwata

1, Robert Buco

2, Masayuki Nishimura

3,

1Shimadzu Corporation, Kyoto, JAPAN;

2Shimadzu Corporation, Marlborough, MA, USA;

3Shimadzu Corporation, Columbia, MD, USA

P-M-131 Purification of Biopharmaceutical Proteins and Peptides using Ion-Exchange Bulk

Media Designed for High Throughput Purification. Noriko Shoji1, Chie Yokoyama

1,

Chiaki Iwata1, Munehiro Shoda

1, Takashi Sato

1, Takatomo Takai

1, Ernest J. Sobkow

2,

1YMC Co., Ltd., Kyoto, JAPAN;

2YMC America, Allentown, PA, USA

P-M-132 SAM-C18 Bulk Packing as Alternative for Large Scale Reversed-Phase Purification.

Hafeez D. Fatunmbi, Separation Methods Technologies, Newark, DE, USA P-M-133 Model-based Conversion of a Single-column Batch Process to 3- and 4-Column

Periodic Counter-current Chromatography. Tobias Hahn, Thiemo Huuk, Fabian Gorlich, Gang Wang, Jurgen Hubbuch, KIT, Karlsruhe, GERMANY




Tuesday Poster Session II Preliminary List of Presentations Posters in the P-200 series will be presented on Tuesday in Poster Session II @ 2:00 - 3:15 PM



P-T-201 Determination of Scale-down Criteria and Evaluation of Different Pumping Modes

to Mimic Commercial Scale Viral Filter Performance. Prasad Pathange, Bayer HealthCare, Berkeley, CA, USA

P-T-202 Process Design Strategy to Monitor and Improve Purification of Influenza Virus-

Like Particles using Click Chemistry. Sofia Carvalho1, Ricardo Silva

3, Joao Freire

2,

Mafalda Moleirinho3, Francisca Monteiro

1, Diana Gaspar

2, Miguel Castanho

2, Paula

Alves1, Gonçalo Bernardes

4, Cristina Peixoto

1, Manuel Carrondo

5,

1IBET/ITQB-UNL,

Oeiras, PORTUGAL; 2IMM, Lisboa, PORTUGAL;


4IMM/University of Cambridge, Lisboa/Cambridge, Portugal/UK;

5IBET/ITQB-UNL/FCT-

UNL, Oeiras/Caparica, PORTUGAL P-T-203 Downstream Processing of Influenza Virus-like Particles using an All-filtration

Technology Platform. Sofia Carvalho1, Ricardo Silva

2, Barbara Cunha

1, Mafalda

Moleirinho2, Alex Xenopoulos

3, Paula Alves

1, Cristina Peixoto

1, Manuel Carrondo

4,

1IBET/ITQB-UNL, Oeiras, PORTUGAL;


3EMD Millipore,

Boston, MA, USA; 4IBET/ITQB-UNL/FCT-UNL, Oeiras/Caparica, PORTUGAL

P-T-204 Positive and Negative Mode Multi-column Processes for Enveloped Virus-like

Particles Purification. Ricardo Silva1, Alex Xenopoulos

2, Paula Alves

3, Manuel

Carrondo4, Cristina Peixoto

3,


2EMD Millipore, Bedford, MA,

USA; 3iBET/ITQB, Oeiras, PORTUGAL;


P-T-205 Development of a Two-step, cGMP-compliant Process for Adenovirus Purification.

Mark Fitchmun1, John Chicca

2, Mark Snyder

3,

1Somatek, San Diego, CA, USA;

2Molecular Diagnostic Systems, San Diego, CA, USA;

3Bio-Rad Laboratories, Hercules,

CA, USA P-T-206 Continuous Purification Platforms for Viral Vectors based on Multicolumn

Simulated Countercurrent Chromatography. Jose Mota1, Ricardo Silva

2, Cristina

Peixoto2, Manuel Carrondo

2,

1LAQV/REQUIMTE and IBET, Caparica, PORTUGAL;

2IBET, Oeiras, PORTUGAL

P-T-207 Experimental Realization of Single-column Batch Chromatography with Recycle

Lag. Abimaelle Chiberio, Snezana Reljic, Rui Ribeiro, Jose Mota, LAQV/REQUIMTE, Caparica, PORTUGAL

P-T-208 Evaluation of Loading Characteristics and IgG Binding Performance of

Staphylococcal Protein A on Polypropylene Capillary-channeled Polymer Fibers. Hung Trang

1, Abby Schadock-Hewitt

2, Liuwei Jiang

1, R. Kenneth Marcus

1,

1Clemson

University, Clemson, SC, USA; 2Bristol-Myers Squibb, Devens, MA, USA

P-T-209 Statistical Evaluation of Performance Parameters of Pre-packed Columns over a

Time Span of Ten Years. Tim Schroeder1, Theresa Scharl Hirsch

2, Christian

Jungreuthmayer2, Astrid Durauer

3, Alois Jungbauer

3,

1Atoll GmbH, Weingarten,

GERMANY; 2Austrian Centre of Industrial Biotechnology, Vienna, AUSTRIA;

3University

of Natural Resources and Life Sciences, Vienna, AUSTRIA P-T-210 Modeling of Anion-Exchange Chromatography: Influence of Ligand Densities on

Protein Separation. Felix Wittkopp1, Lars Peeck

2, Heiner Graalfs

2, Christian Frech

1,

1Hochschule Mannheim University of Applied Sciences, Mannheim, GERMANY;

2Merck

KGaA, Darmstadt, GERMANY







P-T-211 A Comparison of Ordered Internal Column Morphologies Manufactured using 3D

Printing. Suhas Nawada1, Conan Fee

1, Simone Dimartino

2,

1University of Canterbury,

Christchurch, NEW ZEALAND; 2The University of Edinburgh, Edinburgh, UK

P-T-212 In-Silico Process Development: Success Stories. Teresa Beck

1, Thiemo Huuk

1,

Tobias Hahn1, Juergen Hubbuch

2,

1GoSilico, Karlsruhe, GERMANY;

2Karlsruhe Institute

of Technology, Karlsruhe, GERMANY P-T-213 Efficient Separation of Antibodies based on Their Glycan Structures with Affinity

Resin Coupling Engineered Fc Receptor. Yosuke Terao, Toru Tanaka, Naoki Yamanaka, Yoshiharu Asaoka, Masaru Aoki, Shizuka Nishiyama, Seigo Oe, Teruhiko Ide, TOSOH Corporation, Ayase, JAPAN

P-T-214 A Mechanistic Investigation into Chromatography Resin Aging: Scalable and Non-

Scalable Effects on Ionic Capacity. Andrew Pike, Phillip Smith, Bruno Marques, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-T-215 Development of Chromatography Media for High-throughput Purification Process

of Monoclonal Antibody. Yoshito Fukuda, Shoya Yoda, Kazuhiko Tokunaga, Shinya Nozaki, Noriyuki Yasuda, Shouhei Ohara, Masato Towata, Tadashi Adachi, Mitsubishi Chemical, Kitakyushu, JAPAN

P-T-216 Application of QbD for Late Stage Downstream Process Development of a

Monoclonal Antibody based Fusion Protein. George Enriquez, Ying Yang, Judy Miao, Iraj Ghazi, Shire, Lexington, MA, USA

P-T-217 Dedicated Protein A Resins for Clinical Manufacturing, Regular Production, or

Purification of Acid Sensitive MAbs. Hans J. Johansson, Purolite, Llantrisant, UK P-T-218 Accelerated Evolution: Advancing Antibody Affinity Technology to Meet the Needs

of Next Generation Antibody Processes. Jonathan Royce, Mats Gruvegard, Mats Ander, Tomas Bjorkman, Elin Monie, Gustav Rodrigo, Ronnie Palmgren, GE Healthcare, Uppsala, SWEDEN

P-T-219 Optimization of Productivity, Efficiency and Buffer use for Continuous

Countercurrent Tangential Chromatography (CCTC) Platform. Oleg Shinkazh, ChromaTan, State College, PA, USA

P-T-220 Adsorption and Separation of Native and PEGylated Proteins on Anion Exchange

Resins with Varying Length of Polymer Grafting. Mimi Zhu, Preston Fuks, Giorgio Carta, University of Virginia, Charlottesville, VA, USA

P-T-221 Prepacked Chromatography Columns: Evaluation for use in Pilot and Large-Scale

Bioprocessing. Shaun Grier, Saani Yakubu, Shire Pharmaceuticals, Lexington, MA, USA

P-T-222 Influenza Virus Capture using Membrane Chromatography: Improving Selectivity

by Matrix Design and Pseudo-Affinity Ligand Interactions. Florian Taft1, Sebastian

van Teeffelen2, Ana Raquel Fortuna

2, Michael Wolff

2, Udo Reichl

2, Louis Villain

1,

1Sartorius Stedim Biotech GmbH, Goettingen, GERMANY;

2Max Planck Institute for

Dynamics of Complex Technical Systems, Goettingen, GERMANY







P-T-223 Thermodynamic Analysis of Multiple Components Resolution in Chromatography

at Various Temperatures. Gorgi Pavlov, James T. Hsu, Lehigh University, Bethlehem, PA, USA

P-T-224 High Throughput and High Purity Purification with Displacement Chromatography.

Ming Zeng, Pfizer Inc, Groton, CT, USA P-T-225 Screening Approach for the Separation of Pharmaceutical Compounds using Lux®

Polysaccharide-Based Chiral Stationary Phases in SFC Mode. Marc Jacob, Simon Lomas, Phenomenex, Torrance, CA, USA

P-T-226 Development of a Multi-Step Synthetic Peptide Purification Process Utilizing a

Single Stationary Phase. J. Preston1, Marc Jacob

1, Guido Krautz

2,

1Phenomenex,

Torrance, CA, USA; 2Phenomenex, Aschaffenburg, GERMANY

P-T-227 An Operation of the Advanced Simulated Moving Bed Chromatography (A-SMB)

with Reduced Solvent Consumption. Kazuo Okada, Kohei Sato, Masaki Tsuruta, Organo Corporation, Sagamihara, JAPAN

P-T-228 Robust and Efficient Purification of Enantiomers using Novel Polysaccharides

Type Chiral Stationary Phases. Saoko Nozawa1, Mai Sato

1, Akiko Matsui

1, Takashi

Sato1, Tom Seno

1, Noritaka Kuroda

1, Ernest J. Sobkow

2,

1YMC Co., Ltd., Kyoto, JAPAN;

2YMC America, Allentown, PA, USA

P-T-229 A Comparison of Preparative HPLC, Closed-loop Recycling, and Simulated Moving

Bed for Cost-effective Separation of Enantiomers. Saoko Nozawa1, Mai Sato

1, Akiko

Matsui1, Takashi Sato

1, Tom Seno

1, Noritaka Kuroda

1, Ernest J. Sobkow

2,

1YMC Co.,

Ltd., Kyoto, JAPAN; 2YMC America, Allentown, PA, USA

P-T-230 Enzymatic Racemization to Recycle of Undesired Enantiomer in Chiral Separation.

Katarzyna Wrzosek, Thiane Carneiro, Katja Bettenbrock, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY

P-T-231 Isolation and Analysis of Cannabinoids from Hemp and Cannabis Extracts using SFC. Martin Enmark

1, Kurt Levy

2, Brian Reid

2,

1Horizonoid Ltd., Evergreen, CO, USA;

2Ebbu LLC, Evergreen, CO, USA

P-T-232 Little Science – Big Difference in Peptide Purification Processes. Oscar Rebolledo

1,

Imre Sallay2, Keiji Koyanagi

2,

1DAISO Fine Chem USA, Inc., Torrance, CA, USA;

2Osaka

Soda Co., Ltd., Osaka, JAPAN P-T-233 Re-Evaluation of the CIP Step in Insulin-Related RP HPLC Processes. Imre Sallay

1,

Oscar Rebolledo2, Keiji Koyanagi

1,

1Osaka Soda Co. Ltd., Osaka, JAPAN;

2DAISO Fine

Chem USA, Inc., Torrance, CA, USA P-T-234 Purification and Conversion of Bio-mevalonate into Mevalonolactone.

Pyung Cheon Lee, Bun Yeol Lee, Jin Won Kim, Hee Chan Yoon, Ajou University, Suwon, SOUTH KOREA




Leading companies at the forefront of Preparative and Process Chromatography

exhibiting state-of-the-art products, software and services AGILENT TECHNOLOGIES 2850 Centerville Road, Wilmington, DE 19808, USA 800-227-9770 www.agilent.com AKZONOBEL/KROMASIL 281 Fields Lane, Brewster, NY 10509, USA 914-482-7798 www.kromasil.com AkzoNobel offers Kromasil®, high performance chromatographic media based on state-of-the-art spherical silica for UHPLC, HPLC and SFC analysis as well as small scale purification plus bulk material for HPLC, SFC and SMB process technology. Kromasil materials’ unique combination of pore volume and surface area, together with its very high mechanical and chemical stability is unmatched for the separation of a wide variety of substances from small molecules to peptides and proteins. Kromasil is available for an extensive range of NP, RP, SCF and chiral applications providing solutions to the pharmaceutical, natural products, food and beverage, industrial and clinical markets for over a quarter of a century. AVANTOR™ PERFORMANCE MATERIALS 3477 Corporate Parkway, Center Valley, PA 18034, USA 610-573-2600 www.AvantorMaterials.com Avantor™ Performance Materials manufactures and markets high-performance chemistries and materials—including our proven line of J.T.Baker® BAKERBOND™ Process Chromatography Media. Avantor offers the expert collaboration, data transparency and proven quality systems needed to help our global customers advance biopharmaceuticals and biotechnology. Learn more about our robust product portfolio for life sciences by visiting www.avantormaterials.com. BIO-RAD LABORATORIES, INC. 2000 Alfred Nobel Drive, Hercules, CA 94547, USA 800-424-6723 www.bio-rad.com/process Bio-Rad Laboratories is a leading provider to the life science and clinical diagnostics markets where the company’s products are used for scientific discovery, drug development, and biopharmaceutical production. Bio-Rad’s long-lasting customer relationships foster the company's research and development efforts and inspire the introduction of innovative products and solutions that accelerate the discovery process and improve healthcare. The Protein Purification Business, part of the Life Science Group at Bio-Rad, provides researchers with the chromatography tools they need to isolate and purify proteins from laboratory scale into bioprocess manufacturing. With more than 50 years of purification experience, Bio-Rad continues to expand solutions to support each phase of the biotherapeutics purification process. CC BIOTECH LLC 12111 Parklawn Drive, Rockville, MD 20852, USA 240-669-9281 www.ccbiotech.us Novel separations technology available with 2 instruments from CC Biotech, Rockville MD. Coming out is a prep-scale spiral countercurrent chromatograph that can do separations of extracts, peptides, proteins and now, recently reported, carbon nanotubes. Various types of spiral-design rotors will be displayed. Many new analysis methods for life and materials science are possible. The Rotify®, a centrifugal precipitation chromatograph that purifies proteins by precipitation point in a versatile gradient, is shown.

http://www.avantormaterials.com/

http://www.avantormaterials.com/

http://www.bio-rad.com/process

http://www.ccbiotech.us/



exhibiting state-of-the-art products, software and services DAISO FINE CHEM USA INC. / DAISOGEL 3858 W Carson Street, Suite 126, Torrance, CA 90503, USA 310-540-5312 http://www.daisogelusa.com DAISOGEL® is manufactured in our ISO9001 certified facility and bonded in our GMP-compliant facility in Amagasaki, Japan. DAISOGEL® is available in C18, C8, C4 and more bonded phases in wide variety particle sizes from 1.7 micron up to 50 micron. We offer pre-packed columns and bulk silica up to 200kg batches for large-scale production, offering high batch-to-batch reproducibility, excellent particle size distribution, consistent selectivity and high productivity, facilitating scale up and production. ESSENTIAL LIFE SOLUTIONS – EMP BIOTECH 308 Tosca Drive, Stoughton, MA 02072, USA 781-341-7240 www.essential-life.net Essential Life Solutions (Tel 781-341-7240) and emp Biotech (Tel 732-547-7421) are proud to offer a complete package of innovative high quality HPLC/TPLC chromatography columns and matrices. Along with a wide variety of glass and acrylic columns ranging from 5 mm diameters to 2 meters from Essential Life Solutions and a variety of high quality resins from emp Biotech, packed columns are an additional option. Please stop by booth 302 to discuss your requirements. ITOCHU CHEMICALS AMERICA 360 Hamilton Avenue, 6

th Floor, White Plains, NY 10601, USA

914-333-7800 http://www.itochu-purification.com/ Itochu Chemicals America's Separation and Purification group is the exclusive representative for ion exchange resins from Mitsubishi Chemical (Diaion, Sepabeads, MCIGEL, and Relite) and Zeochem chromatography silica (ZEOprep, ZEObead, and ZEOsphere). Mitsubishi Chemical has launched a new line of resins for protein and antibody purification called ChromSpeed (ion exchange) and MabSpeed (Protein A). Zeochem recently launched their ZEOsphere Doped Reverse Phase (DRP) mixed mode reverse phase silica for peptide, oligo, and other charged molecule purifications. JASCO 28600 Mary’s Court, Easton, MD 21601, USA 800-333-5272 www.jascoinc.com JASCO specializes in analytical instruments for chromatography and spectroscopy applications, with over 55 years of experience. JASCO’s worldwide presence, superior product quality and outstanding service and support make the company an industry leader. JASCO offers a complete line of modular chromatography systems including SFC/SFE, HPLC, RHPLC and UHPLC (analytical, semi-prep, & preparative). JASCO is also recognized for its robust and reliable line of spectroscopy products including FTIR, single point and imaging FTIR microscopes, Field-Rugged FTIR, UV-Vis/NIR, Fluorescence, Confocal Imaging Raman Microscopes, Field-Rugged Raman Probes, Polarimeters, Circular Dichroism and Dissolution.

http://www.daisogelusa.com/

http://www.itochu-purification.com/



exhibiting state-of-the-art products, software and services JNC AMERICA 555 Theodore Fremd Avenue, Suite C-206, Rye, NY 10580, USA 914-921-5400 www.jncamerica.com We at JNC Group, “a leading chemical company that aims to contribute to society’s progress through superior technology,” have created progressive products and technologies ever since our founding in 1906 to keep pace with the advancement of society. Our mission is to contribute to a comfortable living, sustainable industry as well as to create products and technologies in harmony with the Earth’s environment. JSR LIFE SCIENCES 1280 N. Mathilda Avenue, Sunnyvale, CA 94089, USA 408-543-8800 www.jsrlifesciences.com JSR Life Sciences provides specialized materials and products to the biotech industry. With its US operations in Sunnyvale, CA, JSR Life Sciences operates a network of manufacturing facilities, sales offices and R&D labs in key markets throughout North America, Europe and Asia-Pacific. JSR Life Sciences is focused on downstream bioprocessing materials for pharmaceutical manufacturing and diagnostics and research reagents. JSR Life Sciences manufactures and markets Amsphere™ A3, a protein A chromatography resin for downstream processing. KANEKA AMERICAS HOLDING 546 Fifth Avenue, 21

st Floor, New York, NY 10036, USA

212-705-4340 www.kaneka.com Kaneka is a worldwide leader, and provider, of Affinity resin technology to the Life Sciences Industry. KANEKA KanCapA™ is a highly efficient protein A affinity chromatography resin designed to improve your monoclonal Antibody (mAb) purification platform. KANEKA KanCapA™ affinity resin is based on a unique combination of a proprietary recombinant alkaline stable Protein A ligand and an innovative highly cross-linked cellulose base matrix. KANEKA KanCapA™ is designed for the industrial–scale purification of monoclonal antibodies. NOVASEP 23 Creek Circle, Boothwyn, PA 19061, USA 610-494-0447 www.novasep.com Novasep is a leading worldwide provider of integrated manufacturing solutions for the Life Science industries. We master a unique range of chromatographic technologies (HPLC, SFC, LPLC, continuous chromatography) for the purification of both synthetic and bio-molecules. With its unique business model, Novasep provides solutions to support strategic decision to either insource or outsource the production of our customer’s target molecules. Our offering includes process development, chromatography units (columns, pumping skids), and contract manufacturing. PIC SOLUTION INC. PO Box 191, Media, PA 19065, USA 484-319-4281 [email protected] www.pic-sfc.com PIC Solution develops and manufactures analytical and preparative scale supercritical fluid chromatographs (SFC) and extraction (SFE) systems. Preparative chromatography equipment ranges from the bench-top SFC-PICLab PREP 100 to the pilot scale SFC-PICLab PREP 1000, a range mirrored by the SFE equipment. The SFC-PICLab Analytic, an analytical SFC designed with automated method development capability in mind and the SFC-PICLab Hybrid which combines analytical and preparative scale systems into a single instrument are also available.



exhibiting state-of-the-art products, software and services PUROLITE LIFE SCIENCES 150 Monument Road, Bala Cynwyd, PA 19004, USA 800-343-1500 (US) or 44-778-531-8440 (UK) www.purolite.com Purolite has over 35 years’ experience providing resin solutions, with dedicated R&D and manufacturing facilities worldwide. Purolite Life Sciences provides APIs and blood purification polymers, Lifetech™ resins for enzyme immobilization, ready to use immobilized enzymes and Chromalite® synthetic chromatographic resins. Our new PuroPhase™ SPE solid phase extraction product line is ideal for clean-up and extraction of polar and non-polar analytes. Praesto® agarose-based media are designed for MAb and recombinant protein purification. which now includes Praesto APc - a new clinical, alkaline-tolerant, modified Protein-A. QUANTUM ANALYTICS 3400 East 3rd Avenue, Foster City, CA 94404, USA 650-312-0900 www.LQA.com Quantum Analytics Value-added distributor of multi-vendor analytical instruments - including Chromatography & Mass Spectrometry systems from Agilent Technologies and Mass Detection Systems from Microsaic. We offer an array of customized instrument financing solutions, technical services, cross-platform system integration, installation, training and product support. SEMBA BIOSCIENCES, INC. 601 Science Dr, Madison, WI 53711, USA 866-634-1114 www.sembabio.com Semba Biosciences pioneered the development of bench top SMB continuous chromatography systems. Our Octave™ product line has become the gold standard for versatility and reliability in lab-scale continuous chromatography. Now we are introducing some exciting new innovations in multicolumn continuous chromatography for bioprocess development and single-use GMP manufacturing. Get inspired and visit our booth. SEPARATION METHODS TECHNOLOGIES, INC. (SMT) 31 Blue Hen Drive, Newark, DE 19713, USA 302-368-0610 https://separationmethods.com Separation Methods Technologies, Incorporated (SMT) is a surface chemistry research and manufacturing corporation founded in 1993. SMT's goal is to provide chromatographers with outstanding specialty columns and bulk packing materials for various separation chemistries, ranging from analytical to the process scale. The primary focus for SMT is on the creation of well-organized functional molecules on substrate surfaces for various functions, including chromatographic applications and materials engineering. SP SCIENTIFIC – GENEVAC 3538 Main Street, Stone Ridge, NY 12484, USA 845-687-0071 www.spscientific.com/genevac World leaders in Centrifugal Evaporator technology, Genevac's high performance systems are designed for use in chemistry, biology and analytical science applications. Whether concentrating a few microliters or removing 100 litres, Genevac’s patented evaporation systems can handle even the most difficult solvents and mixtures without compromising sample purity or integrity. Genevac is part of SP Scientific, a leading manufacturer of specialty equipment for science and industry.

http://www.purolite.com/

http://www.sembabio.com/

https://separationmethods.com/



exhibiting state-of-the-art products, software and services THERMO FISHER SCIENTIFIC 7305 Executive Way, Frederick, MD 21704, USA 800-678-5599 www.thermofisher.com Thermo Fisher Scientific supplies innovative solutions for the world's pharmaceutical and biopharmaceutical industries. With applications that span the drug development process – from drug discovery through large-scale commercial production - we provide a broad range of products and services for cell culture, purification and analytics. POROS® and CaptureSelect™ chromatography resins offer high performance polish and unprecedented affinity chromatography solutions. YMC AMERICA, INC. 941 Marcon Blvd., Suite 201, Allentown, PA 18109, USA 610-266-8650 www.ymcamerica.com YMC America, Inc is engaged in technical support, sales, and distribution of YMC brand products from its main offices and laboratory in Allentown, PA, USA, and its preparative chromatography support and demonstration facility located in San Diego, CA, USA. YMC products include Triart hybrid, HG Series and Chiral Art (coated and immobilized) stationary phases, BioPro CEX and SAX resins and preparative lab, pilot and production K-Prep HPLC Systems and DAC and Glass columns. YPSO-FACTO 10 viaduc Kennedy, 54000 Nancy, FRANCE 33-355 961 656 www.ypsofacto.com YPSO-FACTO, Your Process Secured and Optimized. Ypso-Facto is a service company helping industrial firms to develop, optimize and secure their chemical and biochemical processes. We gather experts from the industrial and academic worlds, with complementary competences in chemistry, biochemistry and process engineering. Our independent services include: - Software to model, simulate and design processes; - Consulting for scientific and technical support; - Laboratory services. We have developed a chromatographic process simulation software, ChromWorks

TM, featuring most

commercial chromatographic processes.

http://www.thermofisher.com/

http://www.ypsofacto.com/

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