official guide and roadmap to the bioprocess theater booth #1001 cevec is a global solution and...
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12:00pm – 1:15pm ROUNDTABLE - Managing the Contract Relationship Chairperson: PatriciaSeymour,Senior Consultant, BioProcessTechnologyConsultants Panelists: StephenTaylor,Senior Vice President, Commercial,FujiFilmDioSynth justinSkoble,Senior Director, Technical Operations, AduroBiotech TomDouville,Director, Biopharmaceutical Development, KolltanPharmaceuticals lilyVakili,Senior Counsel,Faber,Daeufer&itratoPC
CLiNiCAL/COMMERCiAL MANUfACTURiNg TRACk
1:30pm – 1:55pm The Expanding DNA and gene Therapy Market Speaker: TonyHitchcock.,Technical Director,CobraBiologics
2:00pm – 2:25pm Strategies in Large-Scale Manufacturing: Rapid, flexible Capacity Expansion with Novel Utilization of Unique Single-Use facility Design Speaker: joeWypych,General Manager, Seattle Facility,CmCBiologics
2:30pm – 2:55pm from Transactional to Strategic Collaboration in Biopharmaceutical Manufacturing Speaker: uweBuecheler,Senior Vice President, Biopharmaceuticals, Boehringeringelheim
3:00pm – 3:25pm Cell Therapy Commercialization - How Do We get There? Speaker: DavidSmith,VicePresident,GlobalBusinessDevelopment, lonza
3:30pm – 3:55pm Designing and implementing a New State-of-the Art Single-Use facility for Late Stage and Commercial Production Speaker: johnHaney,Senior Project Manager,AvidBioservices
Thursday, June 18 BiO BUSiNESS ROUNDTABLES
10:30am –12:00pm PBOA ExECUTivE ROUNDTABLE: CDMO Challenges and Opportunities Moderator: GilRoth,Founder/President,Pharma&Biopharma OutsourcingAssociation Panelists: ThomasThorpe,Chief Executive Officer,AftonScientific michaelRiley, Vice President and General Manager, CatalentBiologics VictorVinci,Vice President and Chief Scientific Officer, CookPharma AmitArora,Chief Marketing Officer,jubilantHollisterStier
1:00pm-2:30pm WOMEN iN BiO ROUNDTABLE: Women Moving forward and Up: Boldly Taking That Next Step
Moderator: jamieStrachota,ExecutiveDirector,WomeninBio
Panelists: Educational KayWellman,Faculty Member and Coordinator, johnsHopkinsuniversityBiotechnologyEnterprisePrograms Entrepreneur DebBowes,Founder and President,ChevyChaseBioPartners
Science/Business/Law SherriOslick,Partner, mcDonnellBoehnenHulbert&BerghoffllP
Head Hunter AshleyBowman,SearchSolutionGroup
Official Guide and Roadmap toThe BioProcess Theater and Exhibition Zone
Booth #3207
Tuesday, June 16 BiOMANUfACTURiNg STRATEgiES TRACk
12:00pm – 1:15pm ROUNDTABLE - Stretching for the Trifecta: innovative Strategies for Speeding Development, Lowering Costs, and Enhancing Quality Chairperson: ThomasC.Ransohoff,Vice President, BioProcessTechnologyConsultants Panelists: joanneBeck,Senior Vice President, Process Development,Shire markBrower,Senior Research Chemical Engineer,merck lynneFrick,Director, Continuous Processing, The Americas, PallCorporation ParrishGalliher,CTO UpstreamXcellerex,GEHealthcare
CELL LiNE/PROCESS DEvELOPMENT TRACk
1:30pm-1:55pm Using Miniaturization and Automation to improve Cell Line Development and Selection Speaker: KarenFallen,Vice President, Business Unit Head, Clinical Development and Licensing,lonza
2:00pm-2:25pm Media Toolbox - A Rapid and Effective Process Development Strategy to Deliver Reliable, High-Quality Biomanufacturing Processes Speaker: minZhang, Principal Scientist and Group Leader, Upstream Process Development,FujiFilmDioSynth
2:30pm-2:55pm CAP go Cell Expression System - The New Standard in Authentic Human glycosylation Speaker: HartmutTintrup,Chief Business Officer,Cevec
3:00pm-3:25pm implementing Clone generation in fast-Track Manufacturing of Proteins Speaker: GuillaumePlane, Development and Marketing Manager, EmDmillipore
3:30pm-3:55pm Advances in Research Tools to Accelerate Drug Development Speaker: RaymondPrice,Senior Director of Business Development, DiscoverRx
Wednesday, June 17 fORMULATiON/fiLL/fiNiSH TRACk
10:00am-10:25am vaccines, global Health, and the future of fighting TB Speaker: mattFeldman,Senior Manager, Strategic Communications,Aeras
10:30am-10:55am Biopharmaceutical formulation - A Journey from Expression to Patient Speaker: GregAdams,Director, Analytical and Formulation Development, FujiFilmDioSynth
11:00am-11:25am Mitigating the Risk of filling Biologics with an Advanced Aseptic Process and glass-free vials Speaker: BillHartzel,Director of Strategic Execution, CatalentPharmaSolutions
11:30am-11:55am Anatomy of a Lyophilization Process: Considerations for a Successful Tech Transfer Speaker: AnthonyCannon, Head of Drug Product Manufacturing Technology,SamsungBiologics
www.cevec.com
BOOTh #1001
CEvECisaglobalsolutionandserviceproviderfortheproductionofbiopharmaceuticalsusingauniquehumancellexpressionsystem.CEVEC’sCAP gO expressionplatformcomprisesaportfolioofglyco-optimizedhumansuspensioncelllineswhichallowfortailor-madeglycosylationofrecombinantproteins.Thecellsarehighlyefficientfortheproductionofabroadrangeofotherwisedifficulttoexpressglycoproteinsandprovideauthentichumanpost-translationalmodifications.usingitsproprietarytechnology,CEVEChasrecentlyformedajointventurepartnershipwithmid-sizeCmOsbothinEuropeandnewlyalsointheuStooffercGmPproductionservicesinCAPcells.
www.avidbio.com
www.bioxcellence.com
BOOTh #3627
AsaleadingbiopharmaceuticalcontractmanufacturerBoehringer ingelheim BioxcellenceTMofferstailor-madecontractdevelopmentandmanufacturingservicestothebiopharmaceuticalindustry,providingtheentireproductiontechnologychainfromDNAtofillandfinishunderoneroofatitsfacilitiesinBiberach(Germany),Vienna(Austria),Fremont(uSA)andShanghai(China).
www.aeras-cmo.com
BOOTh #301
Aeras Contract Manufacturing,locatedinRockville,maryland,helpsorganizationswiththechallengingandcomplexprocessoftranslatingvaccines(includingsubunitantigenandviralvaccines)andotherbiopharmaceuticals(includingrecombinantproteinsandmonoclonalantibodies)fromtheresearchlabthroughPhasei/iiclinicaldevelopment.inourBSl2facility,weprovideend-to-endsupportfromprocessdevelopmentthroughcGmPmanufacturingandfill/finishofclinicaltrialmaterials.
www.bptc.com
BPTCistherecognizedworldwideleaderinbiologicsCmCconsulting,providingafullrangeoftechnical,regulatory,andstrategicconsultingservicestocompaniesworkingondevelopment,manufacturing,andcommercializationofbiopharmaceuticalproducts.BPTCworkswithclientstofindsolutionstothechallengesofproducingbiopharmaceuticalsupplyfromclone to commercial®.
BOOTh #533
www.catalent.com/biologics
Roadmap to Premier Biopharmaceutical Suppliers
BOOTh #3230
Accelerating the Development of vaccines and Biologics Avid’sexperienceinmammaliancellculturedevelopmentandcGmP
productionofclinicalandcommercial-scalemonoclonalantibodies,recombinantproteinsandenzymesprovidesyourprogramwithapartnertoadvanceyourmoleculeefficientlythroughearlystagedevelopmentandintoafinishedcommercialproduct.AvidisexpandingitsOrangeCountyCalifornia-basedfacility.Designedforlate-stageclinicalandcommercialproduction,thisnewstate-of-the-artfacilitymorethandoublesAvid’scurrentmanufacturingcapacityandfeaturesmultiplesingle-usebioreactors,modularcleanroomsandthelatestinsingle-usetechnology.
Your Partner from Concept to Commercial
Boehringer ingelheim BioxcellenceTM makes outsourcing easy
BOOTh #3301
Catalentisyourstrategicpartnerforbiologicdrugdevelopmentsuccess.Wecreatesmart,tailoredsolutionswithournovelSMARTag™ADCTechnology,oursuperiorgPEx®celllineexpressionsystem,clinicalbiomanufacturingcapabilitiesandintegrateddevelopment,analyticalandclinicalsupplyservicestohelpyougetbetterproductstoclinicfaster.Withourbroadrangeofexpertserviceswedrivefaster,moreefficientdevelopmenttimelinestohelpyoutakemoremoleculestomarketandcreatemoreeffectiveproducts.
Catalent - Smart Biologics. integrated Solutions. Better Treatments.
fully integrated Strategic, Technical and Regulatory Solutions
Tailor-Made glycosylation of Recombinant Proteins
www.lonza.com
www.cobrabio.com
BOOTh #726
Cobra providesacomprehensivebiologicsandpharmaceuticalsserviceoffering,withmulti-functionalandexperiencedprojectteamsnurturingcustomers’productsfrompre-clinicaltocommercialmanufacturewithinthreeGmPapprovedfacilities.WehaveaproventrackrecordinthecontractmanufactureofDNA,microbialandmammalianProteins,VirusesandAPiproducts,providingaone-stop-shopaswellasstand-aloneservicesfromcelllinedevelopmentthroughtothefillandfinishofpre-filledsyringesandinjectablevials.
www.emdmillipore.com
BOOTh #2915
www.cmcbiologics.com
BOOTh #2727
www.bioprocessintl.com
BOOTh #3207
www.samsungbiologics.com
BOOTh #3607
Samsung BioLogicsisafullserviceproviderofQualitydrivencGmPcontractmanufacturingfortheglobalbiopharmaceuticalindustry.Ourfacilitiesareflexiblydesignedforcosteffectiveproductionofbothmonoclonalandrecombinantdrugsubstanceanddrugproduct.Ourintegratedservicesincludeprocessdevelopment,analyticalservices(methoddevelopment,comparability,iPC,lotrelease&stability)aswellasfill&finish,labelingandpackaginginonelocation.Ourqualitysystemsaredesignedforworldwideregulatorycompliance.
Drug Substance and Drug Product Contract Manufacturing
EMD MilliporeisthelifeSciencedivisionofMerck kgaA ofGermanyprovidingbiopharmaceuticalservicesfrompreclinicalthroughcommercialproduction.Provantage™servicesproduceclinicalmaterialforPhi-iitrialsandofferprocessdevelopment,processoptimization,techtransfer,validationandequipmentqualificationservices,improvingproductivity,reducingriskandloweringcosts.
EMD Millipore Biopharmaceutical Services from Preclinical through Commercial Production
Contract Manufacturing Excellence
CMC Biologicsprovidesfullyintegratedbiopharmaceuticalprocessdevelopmentandmanufacturingservices.WithfacilitiesintheuSAandEurope,theCompanyspecializesinthescale-upandcGmPmanufactureofprotein-basedtherapeuticsforpre-clinical,clinicalandin-marketAPiproduction.CmCBiologics’widerangeofcustomsolutionsincludecelllinedevelopmentusingitsCHEf1®expressiontechnologyplatform,processdevelopmentandanalytical,formulationandcharacterizationservices.CmCBiologicsoffersmanufactureofmammaliancellcultureandmicrobialfermentation.
Your Process Development and Manufacturing Partner of Choice
Lonzaisaleadingpartnertothelifesciencesindustry.Forover30years,lonzahasbeenhelpingemergingandlargebiotechcompaniesimproveandadvancetheirinnovativeproducts.Whetherforpreclinical,clinicalorcommercialsupply,lonza’sflexibledevelopmentservices,industry-leadingmanufacturingprocesses,andbroadtechnologyplatformsenableyourproductstoreachtheirfullpotential,faster.lonzaisaglobalcompanywithmorethan40majormanufacturingandR&Dfacilitiesandapproximately9,800employeesworldwide.
A global Leader in Life Sciences
BOOTh #3215
The Premier Scientific Publication to the Biopharmaceutical industryTheKeytoeffectiveproductmarketingistoensureyourexpertiseandsolutionsarewellpositionedwithinandsurroundedbyscientificinformationyourcustomersaremostinterestedin.ThisiswhereBioProcess Internationalexcels.Thisisourexpertise.PartnerwithBPitocreateacustomprogramthatperfectlydeliversyoursolutionstothedecisionmakersthatneeditmost.
BioProcess Zone ExhibitorsCompany Name Booth Number
AAiPharma/Cambridgemajorlaboratories.....................3506Althea..............................................................................................3501AmoytopBiotech........................................................................3220APT....................................................................................................3204AragenBioscience,inc...............................................................3415AsepticTechnologies.................................................................3020Barringtonjameslimited........................................................3504BiOKOREA(KHiDi).......................................................................2909BioProcess International ...........................................3300BloodCentersofAmerica.........................................................3105BostonmountainBiotech.........................................................3509CarbosynthllC............................................................................3117Catalent Pharma Solutions .......................................3301CharlesRiverlaboratories.......................................................3511Cobra Biologics ............................................................ 726CRB....................................................................................................3216CRCPress-Taylor&FrancisGroupllC................................3208CytovanceBiologicsinc............................................................2919Dibaindustriesinc......................................................................3017DVBiologics...................................................................................3013EMD Millipore ............................................................2915EmergentBioSolutionsinc.......................................................3119EmersonProcessmanagement..............................................3405ExcelseBio......................................................................................3606FormexllC....................................................................................3111FUJIFILM Diosynth Biotechnologies ........................3317GoodwinBiotechnology,inc...................................................3109indianaHealthindustryForum..............................................3401KemwellBiopharma...................................................................3408KoreaDrugDevelopmentFund.............................................2901lampireBiologicallaboratories,inc....................................3507loeb&loebllP..........................................................................3608Lonza ..........................................................................3215masyBioServices.........................................................................3100medixScientific&ClinicalResearch.....................................3114meissnerFiltrationProducts....................................................3201NittoDenkoTechnicalCorporation......................................3104NOFCORPORATiON....................................................................3016Oncobiologics,inc.......................................................................3003Patheon...........................................................................................3613PendoTECH....................................................................................3015PhageConsultants......................................................................3610PiramalHealthcare......................................................................3309PuritanProducts,inc..................................................................3102PYRAmiDlaboratories,inc......................................................3601REDBAGSOluTiONS.................................................................3612
Company Name Booth Number
Samsung Biologics ....................................................3607SandozGmbH...............................................................................3409SelexisSA........................................................................................3311SharpPackagingServices.........................................................3203Spectrumlabs.com.....................................................................3200That’sNicellC..............................................................................3001TherapureBiomanufacturing.................................................3500ThomasA.littleConsulting....................................................3510ToxikonCorporation...................................................................3101VGXi..................................................................................................3212Wenderoth.....................................................................................3108WHEATON.......................................................................................3103WorthingtonBiochemical........................................................3009
Contract Services ExhibitorsCompany Name Booth NumberAdvantarlabs.................................................................................631AlfaWassermannSeparationTechnologies.......................5021AlliancePharma...........................................................................5025AmRi...................................................................................................727Avid Bioservices, Inc. ................................................... 533BachemAmericas,inc..................................................................539BioTechnique................................................................................5118BRiBiopharmaceuticalResearchinc......................................840CaseWesternReserveuniversitySchoolofmedicineinnovations.........................................541Coldstreamlaboratories............................................................730CookPharmica...............................................................................734GCT...................................................................................................5019Germfreelaboratories................................................................640GlaxoSmithKlineBiopharmaceuticals....................................349HiQScreen........................................................................................739instituteofindustrialOrganicChemistryBranchPszczyna......................................................................735jubilantHollisterStier...................................................................637KBiBiopharma,inc........................................................................743labSupport.....................................................................................834lSNEContractmanufacturing..................................................741lyophilizationTechnology,inc.................................................737mtibio................................................................................................844multiling..........................................................................................838NEuROSERViCE..............................................................................738OhioClinicalTrialsCollaborative(OCTC)..............................543OnPointCRO...................................................................................644ParagonBioservices,inc..............................................................527PolyPeptideGroup........................................................................635WorldwideClinicalTrials.............................................................842WuXiAppTec,inc...........................................................................643
Companies shown in bold are BPi Theater presenters.