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Week-at-a-GlanceMonday, February 25, 2013Exhibit and Poster Hall Hours: 10:00 am – 6:15 pmProcess Validation andContinuous VerificationAnalytical TechnologiesContract Manufacturing Biopharmaceutical Viral Safety forand Technology Transfer Raw MaterialsBiologicalsAMPMPlenary Keynotes: Duncan Low, Ph.D., Amgen • Drew Kelner, Ph.D., Amgen (Mariner’s Ballroom)QbD for Process MonitoringAchieving Heightened Outsourcing Decision and Selection Improve Your Understanding ofand Control (Grand Ballroom Salon G) Characterization (Grand Ballroom Salon A) Criteria (Driftwood) Raw Material Variability (Fountain)Technology Workshop Sponsored by: Wuxi AppTec (Shoreline) and GE Healthcare (Salon A)Strategic and Statistical Approachesto the New Guidance(Grand Ballroom Salon G)LifeCycle Management and KnowledgeManagement (Grand Ballroom Salon G)Advances in Analytical Technologies –What’s New This Year?(Grand Ballroom Salon A)Analytical Lifecycle Management(Grand Ballroom Salon A)Alliance Integration and SupplyChain Management (Driftwood)Raw Materials and Cell CultureProcess Performance (Fountain)Raw Materials Case Studies andLessons Learned (Fountain)Adventitious Agent Testing Strategies:Current and Future (Shoreline)Regulatory Perspectives onAdventitious Agent Testing: USand EU (Shoreline)Virus Barriers: A Non-HTSTApproach (Shoreline)5:15 Networking Wine and Cheese Reception with Exhibit and Poster Viewing Sponsored by EMD MilliporeTuesday, February 26, 2013 Exhibit and Poster Hall Hours: 10:00 am – 4:15 pmAMPMProcess Validation andContinuous VerificationImplementing Process Validationand Continuous Verification in theNew Paradigm(Grand Ballroom Salon G)Implementing Process Validationand Continuous Verification in theNew Paradigm(Grand Ballroom Salon G)Analytical TechnologiesContract Manufacturingand Technology TransferSequence Variant Analysis(Grand Ballroom Salon A)Process-Related Impurity Analysis(Grand Ballroom Salon A)Technology Workshop Sponsored by: Pall Life Sciences (Shoreline)Product-Related Variantsand ImpuritiesCharacterization of Biosimilars(Grand Ballroom Salon A)BiopharmaceuticalRaw MaterialsScale Up, Technology Transfer and Ensuring Supply Chain TransparencyContract Manufacturing (Driftwood) and Supplier Quality (Fountain)Scale Up, Technology Transfer andContract Manufacturing (continued)(Driftwood)5:30 BDP Week Beach Party (Lighthouse Courtyard)Strategies for Raw MaterialCharacterization and ControlPredictive Knowledge Through NovelRaw Material Monitoring Methods(Fountain)Viral Safety forBiologicalsRisk-Mitigation for VirusContamination (Shoreline)Progress in Better Understandingof Virus Filtration (ShorelineAdventitious Agent Testing:Troubleshooting and Investigationof Unexpected ResultsViral Clearance Studies (Shoreline)Wednesday, February 27, 2013 Exhibit and Poster Hall Hours: 10:20 am – 6:15 pmADC DevelopmentAntibody Development Antibody Development Antibody Developmentand Productionand Production – and Production – and Production –Biosimilar DevelopmentUpstreamDownstreamMfg/Lifecycleand ProductionPlenary Keynotes: Jeffrey C. Baker, Ph.D., CDER, U.S. Food and Drug Administration • Jonathan Coffman, Ph.D., Boehringer Ingelheim • Yongjick Kim, Ph.D., Celltrion, Korea (Mariner’s Ballroom)AMPMEarly Stage Process Development(Driftwood)Integrating Cell Line Developmentwith Discovery (Fountain)Adopting New DownstreamProcessing Technologies(Mariner’s Ballroom)Scale-Up and Tech Transfer(Shoreline)Technology Workshops Sponsored by: 3M (Shoreline), BioRad (Driftwood) and Life Technologies (Mariners)Early Stage Process Development(continued)(Driftwood)Rapid Process Development –Balancing Speed and RiskHost Cell Genomics and ProductionCell Metabolism(Fountain)Adopting New DownstreamProcessing Technologies (continued)Initial Recovery and Capturing - HowQuickly and Effectively Can You Capturethe Product? (Mariner’s Ballroom)Lifecycle Management andRegulatory TrendsNew Technologies and TheirImplementation in Manufacturing(Shoreline)Market Access and PartneringStrategies for Global BiosimilarDevelopment (Catalina)Presentation Sponsored by:DSM Biologics (Catalina)Biosimilars in Emerging MarketsRegulatory Guidelines andHarmonization for the Developmentof Biosimilars(Catalina)5:15 Networking Wine and Cheese Reception with Exhibit and Poster ViewingThursday, February 28, 2013 Exhibit and Poster Hall Hours: 10:00 am – 3:45 pmADC DevelopmentAntibody Development Antibody Development Antibody Developmentand Productionand Production – and Production – and Production –Biosimilar DevelopmentUpstreamDownstreamMfg/Lifecycleand ProductionAMPMAMPMAnalytical Development,Characterization and ComparabilityStrategies for ADCsNext Generation ADCs(Driftwood)Novel Technologies,Approaches and Strategies toImprove Product QualityDevelopment and Implementationof Single Use SystemsScale-Up Considerations for CellCulture Processes (Fountain)Next Generation Polishing Concepts– Maximizing Impurity RemovalContinuous Processing Systems(Mariner’s Ballroom)The Facility of the Future is Here! –What it Means for Current Facilities(Shoreline)Analytical Characterization andBiosimilarity Assessment(Catalina)Technology Workshops Sponsored by: GE Healthcare (Mariners), Finesse Solutions (Catalina), Pall Life Sciences (Shoreline) and Genovis (Driftwood)Late Stage Process Development(Driftwood)Session Keynotes:Friday, March 1, 2013Novel Technologies, Approaches andStrategies to Improve Product Quality(Fountain)Understanding Structure/FunctionRelationships (Mariner’s Ballroom)The Facility of the Future is Here! –What it Means for Current Facilities(Shoreline)Analytical Characterization andBiosimilarity Assessment (continued)(Catalina)Robert S. Gronke, Ph.D., Biogen Idec. • Mary E.M. Cromwell, Ph.D., Genentech, a member of the Roche Group (Catalina)ADC Development and ProductionDevelopment of Bispecific AntibodiesMeet the Speakers Breakfast (Complimentary for attendees who purchased the 5-Day Week Experience Pass) (Fountain)Session Keynotes: Abhinav Shukla, Ph.D., KBI Biopharma • Pete Gagnon, Bioprocessing Technology Institute, Singapore • E. Morrey Atkinson, Ph.D., Bristol-Myers Squibb (Mariner’s Ballroom)Overcoming Facility Implications, Production Issues andManufacturing Challenges (Driftwood)Strategies to Improve the Molecule Design, Solubility, Stability and Half-Life as Well as ReduceToxicity for Bispecific Antibodies (Shoreline)Development of Generic or Platform Production Process for Bispecific AntibodiesStructural and Functional Characterization, Clinical Development and Safety Assessments forBispecific Antibodies (Shoreline)Biopharmaceutical Development & Production Week 3

Monday, February 25, 2013Contract Manufacturing andTechnology TransferBiopharmaceutical Raw Materials Viral Safety for BiologicalsDriftwood Fountain Shoreline7:15 Registration and Coffee8:15 Plenary Keynotes: Duncan Low, Ph.D., Amgen Drew Kelner, Ph.D., Amgen (see details to the left)10:00 Networking Refreshment Break in Exhibit and Poster Hall10:40 Chairman’s RemarksChairman’s RemarksChairman’s RemarksDavid R. Volk, Senior Manager, SSF Production Technology, David Kolwyck, Principal Scientist, Materials Dayue Chen, Ph.D., Research Advisor, ProcessGenentech, Inc., a member of the Roche GroupScience, AmgenDevelopment, Eli Lilly & Co.Outsourcing Decision andSelection Criteria10:45 CMO Selection Criteria –Critical Success FactorsPrasad Gogineni, Associate Director, PharmaTechnology, Watson Laboratories11:15 Key Elements in Successful OutsourcingMorten Munk, Vice President, BusinessDevelopment, CMC Biologics A/S11:45 CASE STUDY CMO Selection Process forBiologics – A Living ProcessPatrick E. Haley, Associate Project Manager,Biologics Strategic Planning and Operations,Allergan, Inc.12:15Improve Your Understanding ofRaw Material VariabilityChallenges with Performance Testing ofRaw MaterialsBaochuan Huang, Principal Engineer,Shire PharmaceuticalsCASE STUDY Predicting mAb ProductYields from Fused PAT Data: Assessing,Quantifying and Understanding Lot-to-LotVariability of mAb Media ComponentsJose C. Menezes, Ph.D., Professor, Institute forBiotechnology and Bioengineering, TechnicalUniversity of Lisbon, PortugalCASE STUDY Raw Material Impurities and theImpact on Media VariabilityChandana Sharma, Ph.D., Principal Scientist,Cell Sciences and Development, SAFCAdventitious Agent TestingStrategies: Current and FuturePathways to Incorporating New Methodsinto Adventitious Agent Testing StrategiesRebecca Sheets, Ph.D., Vaccine Scientific andRegulatory Specialist, NIH/NIAIDTechnology Workshops Sponsored by: (Shoreline) and (Grand Ballroom Salon A) (see details to the left)12:45 Networking Luncheon in Exhibit and Poster HallAlliance Integration andSupply Chain ManagementRaw Materials and Cell CultureProcess Performance2:00 CASE STUDY Managing Product Preparation, CASE STUDY The Impact of Raw MaterialLogistics and Delivery for Cell Therapy Products Variability, Foreign Material and Second SourcingRobert Perry, B.Sc., Head of Manufacturing and Kirin Jamison, Engineering Manager & InterimSupply, Athersys, Inc.Department Head, Drug Substance Manufacturingand Technology, Genentech, Inc.2:30 Sourcing ADC Development andManufacturing Services for a More EfficientSupply ChainJason Brady, Head of Business Development,Conjugates and Cytotoxics, Lonza CustomManufacturing3:00 CASE STUDY Building ManufacturingFlexibility and Supply Chain Agility ThroughRapid Tech TransferDavid R. Volk, Senior Manager, SSF ProductionTechnology, Genentech, Inc., a member of theRoche GroupCASE STUDY Assessment, Monitoring andIn-process Control of Critical Raw MaterialVariability in Mammalian Cell CultureSeongkyu Yoon, Ph.D., Assistant Professor andDirector, Massachusetts BioManufacturing Center,University of Massachusetts LowellPerformance and Quality of Cell CultureMedia Rely on Consistent Raw Materials andReliable Production ProcessesAline Zimmer, Ph.D. Head of Cellular AssayDevelopment and Scale-up Laboratory,Merck KGaA, Germany3:30 Networking Refreshment Break in Exhibit and Poster HallAlliance Integration andSupply Chain ManagementRaw Materials Case Studies andLessons Learned4:15 Panel Discussion: Challenges inContinuously Improving Raw MaterialIncorporating CMOs Into the Supply Chain Understanding on the Journey toIntroductory Remarks and Moderator: Phil Kaminsky, Ph.D., CommercializationProfessor and Chair, Industrial Engineering and Operations Stacey Kaneshiro, Senior Consultant Engineer, BioprocessResearch, University of California, BerkeleyOperations, Bioproduct R&D, Eli Lilly & Company4:45 Panelists:CASE STUDY Effect of Shear Protectant5:15Fauad Hasan, Biologics Strategic Planning and Ops(BSPO), AllerganJason Brady, Head of Business Development, Conjugatesand Cytotoxics, Lonza Custom ManufacturingMorten Munk, Vice President, Business Development,CMC Biologics A/SVariability on CHO Cell Culture Performanceand Titer in Commercial ManufacturingParamjit Kaur, Engineer, Manufacturing Sciences, CellCulture, Genentech, A Member of the Roche GroupNetworking Wine and Cheese Reception with Exhibit and Poster Viewing Sponsored by:PDA Technical Report No. 50: Applicationof Non-Culture Testing Methodology for theDetection of MycoplasmaBarbara J. Potts, Ph.D., Senior Consultant,Potts and Nelson Consulting LLCCASE STUDY Risk Assessment to Identify Porcineand Bovine Viruses that Could Contaminate RawMaterials Used in Vaccine ManufacturingJean-Pol Cassart, Ph.D., Senior Scientist,New Product Analytical Strategies,GlaxoSmithKline Vaccines, BelgiumRegulatory Perspectives onAdventitious Agent Testing: US and EUFDA Perspective The Emerging Methods forVirus Detection; Is There a Role for TheseTechnologies in a Virus Safety Program forBiological Medicinal Products?Kathryn King, Ph.D., Staff Scientist, CDER, US FDA(Via Remote Telephone Presentation)EU Regulator Developments onRequirements for Raw Materials andVirus TestingJohannes Bluemel, Ph.D., Head of Virus SafetySection, Paul-Ehrlich-Institut, Federal institute forVaccines and Biomedicines, GermanyFDA Perspective Regulatory Considerationsfor Viral Safety of Cell SubstratesSantosh Nanda, Ph.D., Microbiologist/PrimaryReviewer, Division of Vaccines and Related ProductsApplications, Office of Vaccines Research andReview, CBER, US FDAVirus Barriers:A Non-HTST ApproachAlternative Approaches to Virus Barriers forBiopharmaceutical Manufacturing ProcessesThomas R. Kreil, Ph.D., Associate Professor ofVirology, Senior Director Global Pathogen Safety,Baxter BioScience, AustriaEffective Prevention of Viral Contaminationin BioreactorsShengjiang Liu, Ph.D., Head and Principal Scientist,Pathogen Safety, Global Biologics Development,Bayer Healthcare PharmaceuticalsBiopharmaceutical Development & Production Week 7

Learn more about Rx-360An International Supply Chain ConsortiumFountain9:00 am Panel Discussion:Preventing Raw Material AdulterationModerator:Martin VanTrieste, Senior Vice President, Quality,AmgenPanelists:Tim Valko, Executive Director, Operations RiskManagement, AmgenDrew Kelner, Ph.D., Executive Director, GlobalAnalytical Sciences, AmgenLucy Cabral, Head, Supplier Quality Managementand Distribution Quality SSF, Genentech, Inc.Robert Arnott, Senior Director, Quality,Baxter Healthcare Corporation12:15 Technology WorkshopShorelineCritical Factors for Optimal ViralFiltration Performance Mónica Cardona, Marketing Manager,Global Air/Vent Product Manager, Pall Life SciencesWin Prizes!The BDP Week Passport ContestDon’t miss out on this fun and interactive experience asyou tour through the BDP Week Exhibit Hall. Stop by theseparticipating exhibitors and get your passport initialedand you could walk away with several prizes along withinnovative ideas. Participants are to turn in their passportat the registration desk by 3:30 pm on Tuesday and againby 3:00 pm on Thursday. Winners will be announcedTuesday at 3:45 pm and again on Thursday at 3:30 pm.The drawing will be held in the back of the exhibit hall nextto the IBC show office. You must be present to win!Prizes for Monday-Tuesday:Swedish Hand Crafted Art Glass donated by Genovis, Booth 225Kindle Fire donated by Patheon, Booth 119Fujifilm Camera donated by Fujifilm Diosynth, Booth 219Kindle Fire donated by Boehringer Ingelheim, Booth 113$200 American Express Gift Card donated by ABL, Booth 226Prizes for Wednesday-Thursday:$150 Visa Gift Card donated by Charles River, Booth 227$150 American Express Gift Card donated by Life Technologies,Booth 312Noise Cancellation Headphone donated by Biotechlogic, Inc.,Booth 211AMX Gift Card donated by Avid Bioservices, Booth 320Fujifilm Camera donated by Fujifilm Diosynth’s, Booth 219Kindle Firedonated by Boehringer Ingelheim, Booth 113Swedish Hand Crafted Art Glass donated by Genovis, Booth 225$200 American Express Gift Card donated by ABL, Booth 226Tuesday, February 26, 2013Process Validation andContinuous VerificationGrand Ballroom Salon G7:30 Coffee8:15 Chairman’s RemarksPeter Calcott, Ph.D., President, Calcott ConsultingImplementing Process Validationand Continuous Verification inthe New Paradigm8:30 Implementing the 2011 ProcessValidation GuidanceVijay Chiruvolu, Director, Corporate Validation,Amgen Inc.9:00How Are Small to Mid-Sized CompaniesIncluding Virtuals Implementing theNew Guidances? (9:15)Peter H. Calcott, Ph.D., President,Calcott Consulting, LLC.Chairman’s Opening RemarksAnders Lund, Ph.D., Principal Scientist, BioanalyticalDevelopment, Genzyme, A Sanofi CompanyFeatured PresentationWhere Is Innovation Still Needed inAnalytical Development?Michael G. Mulkerrin, Ph.D., Vice President,Process Development, OncoMed PharmaceuticalsSequence Variant AnalysisCASE STUDY • UNPUBLISHED DATA AminoAcid Misincorporation – Errors Made byNature and Human During Production ofRecombinant ProteinsLi Tao, Ph.D., Group Leader, Analytical Developmentand Testing, Biologics Manufacture and ProcessDevelopment, Bristol-Myers Squibb Company9:30 CASE STUDY • UNPUBLISHED DATADetection of Low Level Sequence Variants atthe DNA LevelIldana Valisheva, M.S., Senior Research Associate,Protein Analytical Chemistry Department,Genentech, A Member of the Roche Group10:00 Networking Refreshment Break in Exhibit and Poster HallImplementing Process Validationand Continuous Verification in theNew Paradigm (continued)10:45 CASE STUDY A QbD Approach Applied in aDownstream Purification Unit OperationYing Yang, Senior Development Specialist,Purification Process Development, Shire HGT11:15Comparing Small vs. Large Biotech’sApproaches to the FDA’s ProcessValidation Guidance – ResourceLimitations, Cost and Time Challengesand Other Practical ConsiderationsHamid Mollah, Ph.D., Head of Quality Engineeringand Validation, XOMA (US) LLCProcess-Related Impurity AnalysisCASE STUDY • UNPUBLISHED DATA The Use ofOrthogonal Methods for Host Cell ProteinDetection in Pharmaceutical Bulks to AssistProcess DevelopmentJudy Shimoni, Ph.D., Senior Scientist, Departmentof Protein Analytical Chemistry,Genentech, A Member of the Roche GroupUNPUBLISHED DATA Characterization of HostCell Proteins in Biopharmaceuticals Using2D LC-MS/MSPeng Pan, Ph.D., Senior Scientist, TransitionalResearch, Genzyme, A Sanofi Company11:45 CASE STUDY • UNPUBLISHED DATA Some “Ah-Ha”Moments in Host Cell Protein AssaysMartin Vanderlaan, MBA, Ph.D., Director,Analytical Operations, Genentech, A Member ofthe Roche Group12:15Technology Workshop Sponsored by:Analytical TechnologiesGrand Ballroom Salon A12:45 Networking Luncheon in Exhibit and Poster Hall(Shoreline) (see details to the left)8 www.IBCLifeSciences.com/BDPWeek

Tuesday, February 26, 2013Contract Manufacturing andTechnology TransferBiopharmaceutical Raw Materials Viral Safety for BiologicalsDriftwood Fountain Shoreline7:30 Coffee8:15 Chairman’s Opening RemarksVincent Turula, Ph.D., M.B.A., Director, External Affairs,BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.Chairwoman’s Opening RemarksPaula Shadle, Ph.D., Principal Consultant,Shadle ConsultingChairman’s RemarksShengjiang Liu, Ph.D., Head and Principal Scientist,Pathogen Safety, Global Biologics Development,Bayer Healthcare PharmaceuticalsScale Up, Technology Transfer andContract ManufacturingEnsuring Supply Chain Transparencyand Supplier QualityRisk-Mitigation forVirus Contamination8:30 Featured PresentationImproving the Collaboration with ContractingManufacturing Organizations: Role ofQuality AssuranceAmer Alghabban, MSc., Director, Global HeadQuality Assurance, Audit Management,Merck Serono, Switzerland9:00 CASE STUDY In-licensing Outsourced ProductsRachel Alford, Ph.D., Associate Director,Purification Development, Alexion Pharmaceuticals9:30 CASE STUDY Getting From Make Versus BuyDecision to Technology TransferHank Stern, MBA, Associate Director, ContractManufacturing, Genentech, Inc., a member of theRoche GroupRaw Material Reliability: Supply, Complianceand Risk Evaluation FactorsJennifer Garner, Senior Engineer, VaccineTechnology Integration, Raw Materials, MerckRx-360 Consortium ModeratedPanel DiscussionPreventing RawMaterial AdulterationModerator: Martin VanTrieste,Senior Vice President, Quality, AmgenPanelists:Tim Valko, Executive Director, Operations RiskManagement, AmgenDrew Kelner, Ph.D., Executive Director, GlobalAnalytical Sciences, AmgenLucy Cabral, Head, Supplier Quality Managementand Distribution Quality SSF, Genentech, Inc.Robert Arnott, Senior Director, Quality,Baxter Healthcare Corporation10:00 Networking Refreshment Break in Exhibit and Poster HallAdventitious Agent ContaminationPrevention for Mammalian Cell CultureProcesses – Are We There Yet?!Robert D. Kiss, Ph.D., Director,Late Stage Cell Culture, Genentech,A Member of the Roche GroupPhysical Inactivation of SmallNon-enveloped VirusesRaymond Nims, Ph.D., Senior Consultant,RMC Pharmaceutical SolutionsThe MIT/Industry Initiative on PreventingAdventitious Agent Contamination inBiomanufacturingMichael E. Wiebe, Ph.D., President,Quantum Consulting, LLCScale Up, Technology Transfer andContract Manufacturing (continued)10:45 Large Scale Protein Purification using HPLCMargit Holzer, Ph.D., R&D Director, NovasepEnsuring Supply Chain Transparencyand Supplier Quality (continued)Managing Suppliers of Critical Raw MaterialsPaula Shadle, Ph.D., Principal Consultant,Shadle ConsultingProgress in Better Understandingof Virus FiltrationHigh Titer and Highly Purified Virus StocksPreparations in Virus Clearance StudiesHorst Ruppach, Ph.D., Global Manager of ViralClearance and Global Coordinator Virology,Charles River Biopharmaceutical Services, Germany11:15 CASE STUDY Challenges Associated with theTransfer and Manufacture of AntibodyDrug ConjugatesManish Jain, MS, Associate Director of TechnologyTransfer, Manufacturing Sciences, Immunogen, Inc.11:45 Considerations for Effective Manufacturing ofAntibody Drug ConjugatesThomas Rohrer, M.S., Senior Director, ADC andBiochemical Technologics, Lonza, Inc.Risk Assessing New Suppliers – A RecombinantProtein Manufacturer’s PerspectiveLada Laenen, Ph.D., Managing Principal Scientist;Head of Cell Culture and Microbiology, GenzymeCorporation, BelgiumYeast Extracts vs. Protein Hydrolysates:What You Should Know to Mitigate ProcessVariability and Enhance Culture PerformanceChristopher Wilcox, Ph.D., R&D Director, Pharma,Nutrition and Functional Ingredients, KerryThe Smart Way to Optimize VirusFiltration StepsAnika Meyer, Product Manager, Viral Clearance,Sartorius Stedim Biotech GmbH, GermanyMitigating the Artifacts of Virus FilterValidation that Compromise the Scale-DownModelAshley Slocum, Biomanufacturing Engineer,EMD Millipore12:15Technology Workshop Sponsored by:(Shoreline) (see details to the left)12:45 Networking Luncheon in Exhibit and Poster HallBiopharmaceutical Development & Production Week 9

Please join us for theBDP WeekBeach PartyCo-hosted by:Tuesday, February 265:30-6:30 pmLighthouse CourtyardTuesday, February 26, 2013 (continued)2:00Process Validation andContinuous VerificationGrand Ballroom Salon GImplementing Process Validation andContinuous Verification in the NewParadigm (continued)Analytical TechnologiesProduct-Related Variants andImpuritiesCASE STUDY • UNPUBLISHED DATA ProteinPrecipitation During UF/DF – IsConcentratability a Problem with My Molecule?Bernice Yeung, Ph.D., Director, Analytical andFormulation Development, Adnexus, Bristol-MyersSquibb R&D Company2:30CASE STUDY Process Validation Strategies –Case Studies on Enhanced Approaches andContinuous Process VerificationSusanne Richter, Ph.D., Lab HeadDSP Development Cell Culture, SandozBiopharmaceuticals GmbH, AustriaCASE STUDY • UNPUBLISHED DATA MeasuringColor and Understanding Color DifferencesAssociated with Process ChangesChristopher Yu, Ph.D., Scientist, Protein AnalyticalChemistry, Genentech, A Member of the Roche GroupCASE STUDY Making the Leap from DiscreteResin Lifetime Validation Protocols toFeatured Presentation3:00 Continuous Process Verification (2:45)Thomas Hubscher, Scientist I, Process Analytics,Biogen IdecEstablishing Master and Working Cell Banksfor Cell-Based BioassaysNanda Subbarao, Ph.D., Senior Consultant,Biologics Consulting Group, Inc.3:30 Networking Refreshment Break in Exhibit and Poster Hall4:00 Passport Winners AnnouncedImplementing Process Validation andContinuous Verification in the NewParadigm (continued)Characterization of Biosimilars4:15 Panel Discussion:Continuous Verification –How to Set It and Link It to the OtherComponents on a Cost Effective MannerModerator: Peter Calcott, Ph.D., President,Calcott Consulting, LLC.Panelists:Jeffrey C. Baker, Ph.D., Deputy Director,Office of Biotechnology Products, CDER,U.S. Food and Drug AdministrationSusanne Richter, Ph.D., Lab HeadDSP Development Cell Culture, SandozBiopharmaceuticals GmbH, AustriaGrand Ballroom Salon AAssessing Biosimilarity byPhysicochemical MethodsJudy Chou, Ph.D., Vice President, Research andDevelopment, Tanvex Biologics4:45 What Key Assay Support Is Required forBiosimilar Programs from Development toValidation?Christina M. Satterwhite, Ph.D., Director,Laboratory Services, Charles River Laboratories5:15 Close of Day TwoGet Social5:30 BDP Week Beach Party (Lighthouse Courtyard) (see details on left)Join IBC Life Sciences’ LinkedIn group: Bioprocessing Professionals.With more than 8,000 members, you have the opportunity to postquestions and find networking contacts. Get involved today.Follow @IBCBioProcess on Twitter for special offers and news about theevent. Use the #bdpweek hashtag to discuss the event. Stay up to date withIBC Life Sciences and follow us at @IBCBioProcess and @ibcusa.“Like” IBC Life Sciences on Facebook and you will stay up to datewith newly added speakers, conference discounts and more.10 www.IBCLifeSciences.com/BDPWeek

TMTuesday, February 26, 2013 (continued)Contract Manufacturing andTechnology TransferBiopharmaceutical Raw Materials Viral Safety for BiologicalsDriftwood Fountain ShorelineScale Up, Technology Transfer andContract Manufacturing (continued)2:00 CASE STUDY Value-Based Analytical Supportfor a Dynamic Clinical DevelopmentVaccine ProjectVincent Turula, Ph.D., M.B.A., Director, ExternalAffairs, BioTherapeutics Pharmaceutical Sciences,Pfizer, Inc.2:30 CASE STUDY From Disposables to StainlessSteel: Tech Transfer and Scale-UpJohn Bodek, BS/JD, Associate Director, API-LM,Janssen Research & Development, LLC.3:00 Contract Manufacturing of BiosimilarsPatricia Seymour, MBA, CSCP, Senior Consultant,BioProcess Technology Consultants, IncStrategies for Raw MaterialCharacterization and ControlHow Defined Is Chemically Defined Media?David Kolwyck, Principal Scientist, MaterialsScience, AmgenCASE STUDY Impact of Raw Materials(Including Disposables) in Cell CultureApplications: Case Studies and StrategiesMasaru Shiratori, Ph.D., Senior Engineer, LateStage Cell Culture, Pharma Technical Development,Genentech, A Member of the Roche GroupThe Safe Use of Serum and Animal-DerivedMaterialsRosemary Versteegen, Ph.D., CEO, InternationalSerum Industry Association3:30 Networking Refreshment Break in Exhibit and Poster Hall4:00 Passport Winners AnnouncedAdventitious Agent Testing:Troubleshooting and Investigation ofUnexpected ResultsTesting for Adventitious Agents: It Is NotAlways a Routine TaskDayue Chen, Ph.D., Research Advisor, ProcessDevelopment, Eli Lilly & Co.Cell-Based Methods for Virus Detection:The Gold Standard that Can Get YouInto TroubleIvar J. Kljavin, Associate Director, QC Virus,Mycoplasma and Adventitious Agent Management,Genentech, A Member of the Roche GroupMolecular Biology Methods for Viral Safety:Danger Tool or Perfect Solution?Emiliano Toso, Ph.D., Molecular Biology GroupHead, Merck Serono, ItalyScale Up, Technology Transfer andContract Manufacturing (continued)Predictive Knowledge Through NovelRaw Material Monitoring MethodsViral Clearance Studies4:15 CASE STUDY Outsourcing of FormulationsDevelopmentKunal Bakshi, Ph.D., Senior Scientist, Formulations,Pfizer, Inc.4:45 Platform Process Development, HighThroughput Process Analytics and LeanManufacturingRuoheng Zhang, Ph.D., Principal Scientist, ProcessScience, Boehringer-IngelheimIncreased Process Knowledge at Scale throughthe Incorporation of Raw Materials InputMonitoring/Modeling and its Real-Time DirectImpact on Biologic Manufacturing Best PracticesGregory Stromberg, Manufacturing Scientist,Manufacturing Sciences, Biogen IdecCASE STUDY Knowledge Management Tools toSupport In-Process Raw Material Monitoring andControl and Biopharma Process Developmentand Manufacturing throughout the LifecycleJose C. Menezes, Ph.D., Professor,Institute for Biotechnology and Bioengineering,Technical University of Lisbon, Portugal5:15 Close of Day TwoCASE STUDY Evaluating Solvent/DetergentTreatment Using Different VirusPreparationsMichelle Gall, Ph.D., Senior Scientist, PathogenSafety, Grifols Therapeutics, Inc.CASE STUDY Speeding Up Early StageBiologics Development by Employing GenericVirus Clearance Platform TechnologiesWensheng Wang, Ph.D., Senior Staff DevelopmentScientist, Pathogen Safety - Global BiologicsDevelopment, Bayer HealthCare5:30 BDP Week Beach Party (Lighthouse Courtyard) (see details on left)Premier Publication:Media Partners:BioProcess International Magazine Goes Mobile: Available free of chargefor iPad and iPhone BPIMobile provides our 30,000+ readers with aninteractive educational experience designed to improve access to contentwhile creating a forum for readers and authors to connect, interact andproblem solve. Visit the App Store and search for BioProcess International.Event Partners:Advancing Development & ManufacturingPharmTech.comBiopharmaceutical Development & Production Week 11

Plenary KeynotesMariner’s Ballroom8:00 Chairman’s Opening RemarksGünter Jagschies, Ph.D., Senior Director,Strategic Customer Relations, Bio TechnologiesR&D, GE Healthcare Life Sciences, Sweden8:15 Emerging Issues in the Regulationof BioproductsJeffrey C. Baker, Ph.D.Deputy Director, Office of BiotechnologyProducts, CDER, U.S. Food andDrug Administration9:00 CASE STUDY • UNPUBLISHED DATAManufacturing Antibodies of the Future– Utilizing a Low Cost, Low VolumeApproach to Help Solve the R&DProductivity ProblemJonathan Coffman, Ph.D.Director of Bioprocess Engineering,Boehringer Ingelheim9:45 Biosimilar: Challenges and the Path ForwardYongjick Kim, Ph.D.President, Manufacturing andTechnical Operations, Celltrion, Korea12:15 Concurrent TechnologyWorkshopsShoreline3M Technologies that Provide Single-Use,Flexible, Scalable Solutions for FiltrationLaura A. Brown, Marketing Manager, Zeta Plus ProductsDeb Bryan, Senior Project Engineer, 3M Purification, IncDriftwoodExploring the Unique Selectivity ofMixed-Mode Chromatography for ChallengingBiomolecule SeparationsXuemei He, Ph.D., Bio-Rad LaboratoriesMariner’s BallroomHigh Resolution, High Capacity and SaltTolerant Ion Exchange Resins for PolishChromatographyChristine Gebski, Head of the POROS ® ResinBusiness and Global Applications, Life TechnologiesSpeed Networking SessionWednesday, February 27th • 5:45 pm – 6:15 pmExhibit HallParticipants have pre-registered for this session,but there is still space if you are interested. If youwould like to join this session, you must visit theIBC Registration desk by 3:00 pm on Wednesday,February 27th. Take advantage of this opportunity tocreate many valuable relationships at BDP Week.(Pre-registration is required)12 www.IBCLifeSciences.com/BDPWeekWednesday, February 27, 2013ADC DevelopmentAntibody Development andand ProductionProduction – UpstreamDriftwoodFountain7:00 Registration and Coffee8:00 Plenary Keynotes: Jeffrey C. Baker, Ph.D., CDER, U.S. Food and Drug AdministrationJonathan Coffman, Ph.D., Boehringer Ingelheim Yongjick Kim, Ph.D., Celltrion, Korea (see details to the left)10:20 Networking Refreshment Break in Exhibit and Poster Hall11:10 Chairman’s RemarksOlivier Marcq, Ph.D., Senior Principal Scientist,Bioconjugates and Polytides, Biotherapeutics R&D,Pfizer Inc.Early Stage Process Development11:15 UNPUBLISHED DATA Novel Site-SpecificADCs – A Novel Amino Acid IncorporationTechnology in Mammalian CellsFeng Tian, Ph.D., Director, EuCode Technology,Ambrx Inc.11:45 UNPUBLISHED DATA ChemoenzymaticGeneration of Site-Specifically Modified ADCsDavid Rabuka, Ph.D., Chief Scientific Officer,Redwood Bioscience12:15Chairman’s RemarksJohn Joly, Ph.D., Director of Early Stage Cell Culture,Process Development, Genentech, a member of theRoche GroupIntegrating Cell Line Developmentwith DiscoveryUNPUBLISHED DATA Quality by Design Engineering– Use of Upfront Engineering, Diversity Analysisand Early Quality Attribute ScreeningMargaret Karow, Ph.D., Executive Director,Biologics, Amgen Inc.Quality by Design during Cell LineDevelopmentSusan Dana Jones, Ph.D., Vice President and SeniorConsultant, BioProcess Technology Consultants, Inc.Technology Workshops Sponsored by (Shoreline) (Driftwood)(Mariner’s Ballroom)(see details to the left)12:45 Networking Luncheon in Exhibit and Poster HallEarly Stage Process Development(continued)2:00 Concept to Clinic in 365 Days; Design andProduction of Optimized ADCsTrevor Hallam, Ph.D., Chief Scientific Officer,Sutro Biopharma, Inc.2:30 Antibody-Drug Conjugates: TechnologyAdvances in Linkers and Cytotoxic AgentsRavi J. Chari, Ph.D., Executive Director, Chemistryand Biochemistry, ImmunoGen, Inc.3:00 UNPUBLISHED DATA Next Generation ADCs:Higher Drug Loading, Alternative Payloadsand Alternative Targeting MoietiesTimothy B. Lowinger, Ph.D., Chief ScientificOfficer, Mersana TherapeuticsHost Cell Genomics and ProductionCell MetabolismUNPUBLISHED DATA Improving Productivity byBetter Understanding Cell Line MetabolismSohye Kang, Ph.D., Principal Scientist, ProductAttribute Sciences, Amgen Inc.CASE STUDY • UNPUBLISHED DATA Using SyntheticBiology, LEAP and Computational Modeling inan Integrated Platform for Accelerated HumanmAb Discovery and DevelopmentFred Koller, Ph.D., Vice President, ProteinProduction Division, Intrexon Institute forBiomolecular ResearchCASE STUDY • UNPUBLISHED DATA IndustrialProcess Development, A Case Study inEfficiency and AutomationMichael Isaacs, Scientist, Automation andDevelopment, Broadley James Corp.3:30 Networking Refreshment Break in Exhibit and Poster Hall4:15Thought Leadership ForumReducing the Risk of a Contamination EventDue to Raw Materials – Part IIRapid Process Development –Balancing Speed and RiskCASE STUDY • UNPUBLISHED DATA How QuicklyCan You Generate a Stable Cell Line?Rubai Ding, Ph.D., Senior Scientist,Bayer HealthCareSponsored by:4:45 UNPUBLISHED DATA Higher Titer Clones in LessModerator:Time: An Optimized Work Flow for RecombinantBarbara Potts, Ph.D., Senior Consultant, CHO Cell Line DevelopmentPotts and Nelson Consulting, LLCChristine DeMaria, Ph.D., Associate Director, TherapeuticProtein Expression, Genzyme, A Sanofi Company5:15 Networking Wine and Cheese Reception with Exhibit and Poster Viewing

Session KeynotesMariner’s BallroomADC Development and Production8:30 Characterization and ComparabilityStrategies for ConjugatesFred Jacobson, Ph.D.Principal Scientist, Genentech Inc.,a member of the Roche GroupCatalinaBiosimilar Developmentand Production8:30 Realizing the Promise of EmergingBiosimilar SectorThomas Vanden Boom, Ph.D.Vice President, Global Biologics Research,Development and ManufacturingOperations, Hospira Inc.12:15 Concurrent TechnologyWorkshopsMariner’s BallroomNew, Highly Selective Polishing ToolsPeter Hagwall, Ph.D., Product Manager,GE HealthcareDriftwoodAntibody Fragments as Key Molecules in DrugDevelopment and CharacterizationFredrik Olsson, Msc, COO, Genovis AB, SwedenCatalinaTBAShorelineA Novel Salt-Tolerant AnionExchange SorbentWarren Schwartz, Ph.D,Senior Technical Director,Biopharm, SLS Global Technical Support,Pall CorporationThursday, February 28, 2013ADC Developmentand ProductionDriftwood7:30 Coffee8:15 Chairman’s Opening RemarksAleksander Swietlow, Ph.D., Principal Scientist,Analytical R&D, Amgen Inc.Session Keynote8:30 Fred Jacobson, Ph.D., Genentech Inc., amember of the Roche Group (see details to the left)Analytical Development,Characterization and ComparabilityStrategies for ADCs9:00 UNPUBLISHED DATA Considerationsabout Mass Spectrometric Analysis ofMaytansinoid ADCsAlex Lazar, Ph.D., Head of Analytical andPharmaceutical Sciences, ImmunoGen, Inc.Antibody Development andProduction – UpstreamFountainChairman’s RemarksRüdiger Heidemann, Ph.D., Senior StaffDevelopment Scientist, GBD,Cell Culture Development, Bayer HealthcareNovel Technologies,Approaches and Strategies toImprove Product QualityCASE STUDY • UNPUBLISHED DATA Stabilityof Monoclonal Antibodies in UpstreamProcessing ConditionsKurt Lang, Ph.D., Head of Protein Sciences,Roche Diagnostics GmbH, GermanyCombining Genetic and Analytical Methods toID and Eliminate Sequence Variants in ClonalCell LinesKarin Anderson, Ph.D., Senior Principal Scientist,Bioprocess Research and Development, Pfizer Inc.9:30 UNPUBLISHED DATA Analytical Development Evaluating and Minimizing Sequence Variantsand Characterization for Antibodyduring Recombinant Protein ProductionDrug ConjugatesMichael Laird, Ph.D., Associate Director, SeniorApril Xu, Ph.D., Senior Principle Scientist, GroupScientist, Late Stage Cell Culture, Genentech, aLeader, Pfizer Inc.member of the Roche Group10:00 Networking Refreshment Break in Exhibit and Poster HallNext Generation ADCs10:45 Complex Drug Targeting:A New Paradigm for SelectivityJames R. Prudent, President and Chief ScientificOfficer, Centrose11:15Featured PresentationNew Challenges and Opportunities inADC ManufacturingMorris Rosenberg, Ph.D., Principal Consultant,MRosenberg BioPharma Consulting LLC.11:45 Panel Discussion: Solutions to Challengesof Characterization and Comparability ofAntibody Drug ConjugatesModerator:Aleksander Swietlow, Ph.D., Principal Scientist,Analytical R&D, Amgen Inc.12:15 Technology WorkshopsSponsored by(Driftwood)(Mariner’s Ballroom)(Catalina)(Shoreline) (see details to the left)Development and Implementation ofSingle Use SystemsCASE STUDY • UNPUBLISHED DATA Developmentof an Entirely Single Use Upstream PlatformRüdiger Heidemann, Ph.D., Senior StaffDevelopment Scientist, GBD,Cell Culture Development, Bayer HealthcareCASE STUDY • UNPUBLISHED DATA Developmentof a Single Use Process Platform withFlexibility for Multiproduct CHO Cell andBaculovirus Expression at 1,000 L Scale in aGMP Manufacturing FacilityStewart McNaull, Ph.D., Section Leader, UpstreamProcess, Fujifilm Diosynth Biotechnologies U.S.A., Inc.Scale-Up Considerations for CellCulture ProcessesCASE STUDY • UNPUBLISHED DATA HighThroughput Model for Perfusion Cell CultureProcess DevelopmentJianguo Yang, Ph.D., Principal Scientist, CommercialCell Culture Development, Genzyme, A SanofiCompanyFeatured PresentationUNPUBLISHED DATA Application of GenomicTechnologies to Cell Line DevelopmentNicole Borth, Ph.D., Professor, Department ofBiotechnology, University of Bodenkultur, Austria12:45 Networking Luncheon in Exhibit and Poster Hall14 www.IBCLifeSciences.com/BDPWeek

Thursday, February 28, 2013Antibody Development andProduction – DownstreamAntibody Development andProduction – Mfg/LifecycleBiosimilar Developmentand ProductionMariner’s Ballroom Shoreline Catalina7:30 Coffee8:15 Chairman’s RemarksJonas Anders, Ph.D., Global Marketing Director,Purification Chromatography, EMD MilliporeNext Generation Polishing Concepts– Maximizing Impurity Removal8:30 Achieving High Mass Throughput ofTherapeutic Proteins through ParvovirusFiltersJonida Basha, M.S., Process Engineer, Pfizer Inc.Chairman’s Opening RemarksHoward Levine, Ph.D., Founder,President and Principal Consultant,BioProcess Technology ConsultantsThe Facility of the Future is Here! –What it Means for Current FacilitiesEfficient Development and ClinicalManufacturing of mAbs for Proof-of-ConceptJens H. Vogel, Ph.D., Executive Director, ProcessScience and Technology Officer, BoehringerIngelheim Fremont, Inc.Chairwoman’s Opening RemarksNanda Subbarao, Ph.D., Senior Consultant,Biologics Consulting Group, Inc.Session KeynoteThomas Vanden Boom, Ph.D., Hospira Inc.(see details to the left)Featured Presentations9:00 Cation Exchange Chromatography inDownstream Processing of MonoclonalAntibodies: How Resin Characteristics ImpactAggregate Removal EfficiencyLars H. Peeck, Ph.D., Head of Polymer SorbentsChromatography R&D, EMD Millipore, Germany9:30 The Present State-of-the-Art Viral Filtration:What Can We Expect?Dayue Chen, Ph.D., Research Advisor, ProcessDevelopment, Eli Lilly and CompanyCASE STUDY • UNPUBLISHED DATA How Do YouImplement Aspects of the Facility of theFuture in Current Facilities?Paul Jorjorian, M.S., Manager, PurificationDevelopment, Gallus BioPharmaceuticals LLCImplementing Disposable Chromatography:Technology Fit in Downstream PurificationFletcher L. Malcom, MBA, Product & MarketingManager, RepligenWhat Have We Learned About Immunogenicityof Biologics and What Do We Expect fromBiosimilars? Impact on the ImmunogenicityTesting Strategy of BiosimilarsMelody Sauerborn, Ph.D., Senior ExpertImmunogenicity, TNO (Netherlands Organizationfor Applied Scientific Research), The NetherlandsEffect of Biosimilar Development on GlobalManufacturing CapacityPatricia Seymour, MBA, CSCP., Senior Consultant,BioProcess Technology Consultants, Inc.10:00 Networking Refreshment Break in Exhibit and Poster HallContinuous Processing Systems10:45 UNPUBLISHED DATA The Potential forContinuous Chromatography in ClinicalManufacturing of BiopharmaceuticalsThomas C. Ransohoff, M.S., Vice President andSenior Consultant, BPTC11:15 UNPUBLISHED DATA Continuous Chromatography– Validation and Regulatory PerspectivesKarol Lacki, Staff Scientist, R&D, GEHC Life SciencesBiotechnologies, SwedenLauren Melton, RAC, Strategic Regulatory MarketingDirector, GEHC Life Sciences BiotechnologiesThe Facility of the Future is Here!What it Means for Current Facilities(continued)Manufacturing: Planning for Qualityand ControlJason J. Osman, Ph.D., Technical Director,Operations, Lonza Biologics plc, United KingdomCASE STUDY Reality of Living with aDisposable Facility – Supply Chain ChallengesTara Yokomizo Ponce, Senior ProcurementManager, Global Pharma Procurement, Genentech,a member of the Roche GroupAnalytical Characterization andBiosimilarity AssessmentLate Stage Analytical Development ofBiosimilars and the “Totality of Evidence”ConceptHans-Martin Mueller, Ph.D., Associate Director,BioProcess Development, Merck & Co.Characterization of Biological ProductsUsing HPLC, CE, Mass Spectrometry,NMR and Other Analytical TechniquesHui Zhao, Ph.D., Senior Fellow and Lab Head,Technical R&D, Process Sciences and Production,Novartis Pharma AG, Switzerland11:45 CASE STUDY What Can ContinuousProcessing Do for You?Mark Brower, Ph.D., Associate Principal Scientist,Merck & Co., Inc.12:15How Do You Manage the ManufacturingFacility of the Past? Optimizing Operationswithin the Existing FacilityLee Allen, Principal Group Leader, Lonza Biologics,United KingdomParadigms for Biotech/Biosimilar ProductCharacterization and ComparabilityNanda Subbarao, Ph.D., Senior Consultant,Biologics Consulting Group, Inc.Technology Workshops Sponsored by (Mariner’s Ballroom) (Driftwood) (Catalina) (Shoreline)(see details to the left)12:45 Networking Luncheon in Exhibit and Poster HallBiopharmaceutical Development & Production Week 15

Session KeynotesMariner’s Ballroom3:45 CASE STUDY • UNPUBLISHED DATA Impactof Non-Compendial Raw Material onProcess Variations and Options forProcess Control – Several ApproachesMay Be NecessaryThursday, February 28, 2013ADC Developmentand ProductionDriftwoodLate Stage Process Development2:00 Developing Robust Conjugation ProcessesMichael Sun, Ph.D., Associate Director, Purification& Conjugation Development, Seattle GeneticsAntibody Development andProduction – UpstreamFountainNovel Technologies, Approaches andStrategies to ImproveProduct QualityUNPUBLISHED DATA The Control of AntibodyGlycosylation ProfilesMichael Butler, Ph.D., Professor, Department ofMicrobiology, University of ManitobaRobert S. Gronke, Ph.D.Senior Principal Scientist,Biogen Idec4:30 Integrating Analytical with EmergingTrends in Drug Development -High Concentration FormulationDevelopmentMary E.M. Cromwell, Ph.D.Director, Late Stage PharmaceuticalDevelopment, Genentech, amember of the Roche Group2:30 CASE STUDY What Are the Important CQAsfor the Small Molecule?Nathan Ihle, Ph.D., Executive Director, ProcessChemistry, Seattle GeneticsProcess Modifications for ControllingGlycosylation Patterns of MAbsRodney Combs, Associate Research Fellow,Bioprocess R&D, Culture Process Development,World Wide Pharmaceutical Sciences, Pfizer Inc.3:00 Networking Refreshment Break and Last Chance for Exhibit and Poster Viewing3:30Passport Winners Announced3:45 Session Keynotes:Robert S. Gronke, Ph.D., Biogen Idec.Mary E.M. Cromwell, Ph.D., Genentech, a member of the Roche Group(see details to the left)5:15 Close of Day Four16 www.IBCLifeSciences.com/BDPWeek

Thursday, February 28, 2013Antibody Development andProduction – DownstreamAntibody Development andProduction – Mfg/LifecycleBiosimilar Developmentand ProductionMariner’s Ballroom Shoreline CatalinaUnderstanding Structure/FunctionRelationshipsThe Facility of the Future is Here! –What it Means for Current FacilitiesAnalytical Characterization andBiosimilarity Assessment (continued)2:00 CASE STUDY Protein-Sequence BasedDetermination of Immunogenicity –The Rituximab vs. Ofatumumab Case StudyAnne S. DeGroot, M.D., Chief Executive Officer,Chief Scientific Officer, Epivax, Inc.2:30 UNPUBLISHED DATA Model-Based ProcessUnderstanding – How It Can Apply to theCreation of a Downstream Process?Daniel Bracewell, Ph.D., Senior Lecturer in BiochemicalEngineering, University College London, United KingdomFlexible Facility Design and AdaptationJoseph K. McLaughlin, M.D., Associate ResearchFellow/Biologics Research and Development,Pfizer Inc.CASE STUDY • UNPUBLISHED DATADebottlenecking Stainless Steel Facilities toModern State-of-the-Art Manufacturing PlantsRolf Douwenga, Ph.D., Vice President, Global R&S,DSM Biologics, The NetherlandsFreedom-To-Operate Issues inCell Line DevelopmentKelly Morron, M.S., J.D., Counsel,Schiff Hardin LLPAntibody Aggregation by Complexation withChromatin: Ramifications and RemediesPete Gagnon, MS., Senior Research TechnologySpecialist, Downstream Processing,Bioprocess Technology Institute, Singapore3:00 Networking Refreshment Break and Last Chance for Exhibit and Poster Viewing3:30Innovations and Enabling Technologies forPassport Winners AnnouncedBiosimilar Development and Production3:45 Session Keynotes:Robert S. Gronke, Ph.D., Biogen Idec.Mary E.M. Cromwell, Ph.D., Genentech, a member of the Roche Group(see details to the left)5:15 Close of Day Four(3:45) What Key Assay Support Is Requiredfor Biosimilar Programs from Developmentto Validation?Christina M. Satterwhite, Ph.D., Director,Laboratory Services, Charles River Laboratories(4:15) CASE STUDY Production of A BiosimilarTrastuzumab and Other Protein-BasedDrugs in PlantsJ. Christopher Hall, Ph.D., Professor, School ofEnvironmental Sciences, University of Guelph, Canada(4:45) Disposables Manufacturing for BiosimilarsJudy Chou, Ph.D., Vice President, R&D,Tanvex Biologics, Inc.(5:15) Close of Day FourJoin Us AgainNext YearMarch 24-28, 2014Hilton Bayfront Hotel • San Diego, CAWEEKbd pBiopharmaceuticalDevelopment & ProductionMethods & Molecules2014Biopharmaceutical Development & Production Week 17

Meet the Speakers BreakfastFountain7:15 am - 8:00 amComplimentary for attendees who purchasedthe 5-Day Week Experience Pass.Pre-registration required.After an intensive week of learning; we inviteyou to come mix and mingle with the conferencespeakers over breakfast. Not only does this passgive you unlimited access to the entire week – butnow you have exclusive access to interactive Q&Awith some of our speakers.Session KeynotesMariner’s Ballroom8:00 Chairman’s Opening RemarksHoward Levine, Ph.D., President,BioProcess Technology Consultants8:15 Innovations in BiopharmaceuticalProduction – A Manufacturer’sPerspectiveAbhinav Shukla, Ph.D.Vice President, Process Developmentand Manufacturing, KBI Biopharma8:45 Disruptive Technology for Purification ofBiosimilar and Biobetter AntibodiesPete GagnonSenior Research Technology Specialist,Bioprocessing Technology Institute,Singapore9:15 Drug Substance Fragmentation -Managing Changes on a Global Scale andHarmonization of SpecificationsE. Morrey Atkinson, Ph.D.Vice President, Process Sciences,Bristol-Myers SquibbFriday, March 1, 2013ADC Developmentand ProductionDriftwood7:30 Coffee8:00 Session Keynotes: Abhinav Shukla, Ph.D., KBI BiopharmaPete Gagnon, Bioprocessing Technology Institute, SingaporeE. Morrey Atkinson, Ph.D., Bristol-Myers Squibb – (see details to the left)9:45 Networking Refreshment BreakOvercoming Facility Implications,Production Issues andManufacturing Challenges10:15 Facility Implications - How to DesignFacilities to Handle Larger(Commercial)Batches EffectivelyMary Robinette, Process Lead, Engineering, SAFC10:45 Safety Handling of Antibody-DrugConjugates in R&D and Manufacturing andthe SafeBridge Certification ProcessJohn Farris, President and Chief Executive Office,SafeBridge Consultants, Inc.11:15 Points to Consider in the Development of aControl Strategy for an ADCPaul McCormac, Ph.D., Director, Bio-manufacturingSciences Group, Pfizer Global Supply, Pfizer Inc.11:45 Lunch on Your OwnOvercoming Facility Implications,Production Issues andManufacturing Challenges1:30 A CMOs Perspective on ADC DrugSubstance Manufacturing - Challenges withScale Up, Safety Issues, Critical ProcessParameters and Tech TransfersMichael Bienkowski, Ph.D., Manager,Process Development, SAFC Pharma2:00 UNPUBLISHED DATA Implementing anAutomated Pre-Clinical Filling Line for ADCsat Pilot ScaleJoseph Sexton, Senior Supervisor, Process DevelopmentOperations, Purification and Filling Pilot Plant,Genentech, a member of the Roche Group2:30 Considerations for Effective Manufacturingof Antibody Drug ConjugatesJason Brady, Head of Business Development,Conjugates and Cytotoxics,Lonza Custom Manufacturing3:00 Panel Discussion:Best Practices, Regulations and Certificatesfor Handling Highly Potent CompoundsAppropriatelyModerator:John Farris, President and Chief Executive Officer,SafeBridge Consultants, Inc.3:30 Close of BDP WeekDevelopment ofBispecific AntibodiesShorelineStrategies to Improve the MoleculeDesign, Solubility, Stability and Half-Life as Well as Reduce Toxicity forBispecific AntibodiesUNPUBLISHED DATA Modular Development ofmAb2 Bispecific Antibody Drug Candidatesin OncologyJohn Haurum, Ph.D., M.D., Chief Executive Officer,F-starCASE STUDY • UNPUBLISHED DATA EngineeringAntibody Fc Region for Heterodimericand Monomeric Form of Fc: Applicationsto Bispecific and Monovalent IgG withEnhanced FunctionalitiesGunasekaran (Guna) Kannan, Ph.D., PrincipalScientist, Biologics Optimization, Amgen Inc.CASE STUDY • UNPUBLISHED DATA AzymetricAntibody Design: Impact on Developabilityof Bispecific TherapeuticsSurjit Dixit, Ph.D., Chief Technology Officer,Zymeworks Inc.Development of Generic orPlatform Production Process forBispecific AntibodiesUNPUBLISHED DATA Development of a GenericBispecific Purification PlatformJosefine Persson, Ph.D., Senior Group Leader,Genentech, a member of the Roche GroupCASE STUDY • UNPUBLISHED DATA Developmentof a Platform Purification Process forBispecific MoleculesKenneth Kang, Ph.D., Principal Scientist,BioProcess Sciences, ImClone Systems, a whollyownedsubsidiary of Eli Lilly and CompanyStructural and FunctionalCharacterization, ClinicalDevelopment and Safety Assessmentsfor Bispecific AntibodiesInnovations in Bispecfic AntibodiesLaurie Iciek, Ph.D., Principal Toxicologist,Translational Sciences, MedImmune, Inc.CASE STUDY Bispecific Antibodies -Combining Different Specificities to AchieveSuperior FunctionalityUlrich Brinkmann, Ph.D., Senior Principle Scientist,Roche Pharma Research & Early Development,Germany18 www.IBCLifeSciences.com/BDPWeek

NEWTHISYEARIBC Life Sciences Presents State-of-the-Art…Flexible FacilitiesInnovative Biopharmaceutical Manufacturing Solutions for Multi-Product Pipelines,Global Markets, On-Demand Scale-Up/Scale-Down and Capacity OptimizationApril 2-4, 2013 • The W Hotel • San Francisco, CAAre Your Facilities and CMO’s Prepared for…• Multi-product/Multi-use Facilities• On-Demand Scale-Up/Scale-Down• Mobile and Modular Concepts• Implementation of Single-Use• Diverse Products: Vaccines, mAbs• Clinical and Commercial Flexibility• Rapid Facility Deployment• Regulatory, Quality & Technical Risks7 Case Studies Illustrate How to Enhance Your Production StrategiesLearn More at: www.IBCLifeSciences.com/FacilitiesBiopharmaceutical Development & Production Week 19

IBC’s 9th AnnualCell Line Development& EngineeringMay 20-22, 2013Hyatt Regency La Jolla at AventineLa Jolla, CAImprove All Aspects of Bioproduct Development by LeveragingCutting-Edge Technical and Process Innovation“This is an outstanding venue for bringing together expertsin the field, vendors, scientists and other interested parties,and the collaborative and open environment has always”been rewarding. This meeting is on my calendar every year!– Gene Lee, Ph.D., Director, Protein and Cell Sciences, EMD Seronowww.IBCLifeSciences.com/CellLineBiopharmaceutical Development & Production Week 21

Exhibit HallWednesday, 10:20 am – 6:15 pmThursday, 10:00 am – 3:45 pm3M ............................103AbD Serotec .....................310Advanced Biosciences Laboratories(ABL, Inc.) ......................226Alfa Wassermann SeparationTechnologies.....................309Aragen Bioscience.................327Asahi Kasei Bioprocess .............212Atoll ...........................311ATR, Inc.........................119Avid Bioservices, Inc ...............320BAC B.V. The Affinity Experts ........122BD Biosciences ...................114Biopharma International ...........100BiOptix .........................112Bio-Rad Laboratories ..............319BioTechLogic, Inc. ................211BKT21 .........................222Boehringer Ingelheim ..............113Broadley-James Corporation ........128C Technologies, Inc. ...............223Catalent ........................118Charles River.....................227CMC Biologics ...................209Cobra Biologics ..................323Cook Pharmica...................214EMD Millipore ...................229Eurofins Lancaster Laboratories......315Finesse Solutions .................329FrieslandCampina DOMO ..........210Fujifilm Diosynth Biotechnologies ....219Gallus Biopharmaceuticals LLC ......115GE Healthcare ...................303Genovis.........................225Gyros ..........................307Innovative Directions ..............207Irvine Scientific ...................308Kaneka Corporation...............328KBI Biopharma, Inc. ...............208Kemwell Biopharma ...............224Kuhner Shaker Inc.................215Kyowa Hakko USA ................313Laureate Biopharma...............202Life Technologies .................312Lonza ..........................306Natrix Separations ................321Novasep ........................314Pall Life Sciences..................203SalesOffice122 128118114112102100121119115113111109107103228226224222218214212210208206202Parker-domonick hunter............213PendoTECH .....................107Repligen ........................221Sandoz .........................318Sanofi CEPiA ....................228229227225223221219215213211209207203Entrance328326322320318314312310308306302Speed Networking(Wed.)329327323321319315313311309307303Sartorius-Stedim Biotech ...........218Semba Biosciences, Inc. ............322Spectrum Laboratories .............102Therapure Biopharma .............206Thermo Scientific .................30222 www.IBCLifeSciences.com/BDPWeek

Join Us in Boston in SeptemberSeptember 16-20, 2013Hynes Convention CenterBoston, MATHE Industry Meeting Place to ExchangeReal-World Solutions to Improve Speed, Cost and Qualitywww.IBCLifeSciences.com/BPIBiopharmaceutical Development & Production Week 23

Register Today and Gain Access to Two Co-Located Events: June 3-5, 2013 • Durham Convention Center • Durham, NCIBC’s 10th AnnualSingle-Use Applicationsfor Biopharmaceutical ManufacturingIBC’s 4th Annual International ForumImprove Yield and Reduce Cost in Vaccine ProductionInnovation and Adoption of Single-Use Technologyfor Upstream, Downstream and Beyond• New Sessions to Prepare You for the Future of Single-Use Applications• Quality by Design (QbD), Technical Diligence and Scale-Down Modeling• Integrated, Flexible, Modular, Single-Use Facilities• Supply Chain and Reliability of Components• Gain Valuable Insights on Deploying Single-Use Applicationsfor Commercialization and Timely Market Delivery of YourTherapeutic Product• QbD and DOE: Learn how these Methods Can MaximizeCapabilities and Minimize Riskwww.IBCLifeSciences.com/SingleUseYour Knowledge with New Topics and Research Covering Delivery,QbD Implementation and Multi-Component/Alternative VaccinesWho is Using Single-Use Technology and WhyProduct Development with More Robust Formulationand CharacterizationGreater Insight on Process and Manufacturing Challengeswww.IBCLifeSciences.com/VaccinesIBC Life SciencesBioprocess Training AcademyTwo-Day Intensive Training Courses for Spring 2013West CoastMay 14-15, 2013DoubleTree by Hilton San Diego/Mission ValleySan Diego, CATrain Your Team This Spring!East CoastJune 12-13, 2013Le Méridien Cambridge-MITCambridge, MAIncrease Job Skills • Develop Solutions • Gain Industry Insight • Expand Your NetworkCourse Offeringsm Introduction to Biopharmaceutical Manufacturingm Introduction to Vaccine Development & Manufacturingm Introduction to Downstream Processing in Biomanufacturingm Cell Culture and Fermentation Bioprocessingm Analytical Method Development and Validationfor Therapeutic Proteinsm CMC Analytical, Comparability and Stability Studiesfor Biotechnology and Biosimilar ProductsSave $200 If You Register by March 15 at: www.IBCLifeSciences.com/courses24 www.IBCLifeSciences.com/BDPWeek

Register Today and Gain Access to Two Co-Located Events: June 26-28, 2013 • Hotel del Coronado • San Diego, CANext GenerationProtein TherapeuticsSummitCross-Fertilize Ideas from Different Disciplinesand Turn Promising New Molecules into ProductsIBC’s InauguralBioconjugates:From Targets to TherapeuticsAdvance Your Programs in Discovery, Design,Development and CMC ManufacturingGain a Competitive Advantagefor Your Protein Therapeutics{ Beyond Antibodies{ Creative ProteinEngineering & Design{ Accessing Difficult &Intracellular Targets{ Bispecifics & Genetic Fusions{ Targeting Strategies& Protein Delivery{ Exploiting the ImmuneSystem for Cancer Therapywww.IBCLifeSciences.com/ProteinSummitImprove Your Therapeutic Candidate’sProcess and Manufacturability withUnpublished Information on:• Design of Linkers and Selection ofTargets and Payloads• Analytical Methods and Characterization• Safety Evaluation and Control of Impurities• Process Development and Manufacturing• Regulatory Concernswww.IBCLifeSciences.com/BioconjugatesBiopharmaceutical Development & Production Week 25

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Event Calendar for 2013February/March 2013Biopharmaceutical Development& Production WeekHyatt Huntington Beach, CA • February 25-March 1, 2013• Process Validation & Continuous Verification• Analytical Technologies• Contract Manufacturing & Technology Transfer• Raw Materials• Viral Safety• Antibody Development & Production• Antibody Drug Conjugate Development & Production• Manufacturing & Lifecycle Management• Biosimilar Development & Production• Development of Bispecific Antibodieswww.IBCLifeSciences.com/BDPWeekAsiaTIDESFebruary 26-28, 2013Sheraton Miyako Hotel • Tokyo, Japanwww.IBCLifeSciences.com/AsiaTIDESApril 2013Flexible FacilitiesApril 2-4, 2013 • The W Hotel • San Francisco, CAwww.IBCLifeSciences.com/FacilitiesMay 2013TIDES: Oligonucleotides and Peptide TherapeuticsFrom Research through CommercializationMay 12-15, 2013 • Hynes Convention Center • Boston, MAwww.IBCLifeSciences.com/TIDESHuman Factors for Drug-DeviceCombination ProductsMay 14-15, 2013 • Bethesda Marriott • Bethesda, MDwww.IBCLifeSciences.com/HumanFactorsDevelopment, Validation and Maintenance ofBiological AssaysMay 14 - May 16, 2013 • Grand Hyatt Seattle • Seattle, WAwww.IBCLifeSciences.com/BioassaysBioprocess Training AcademyMay 14-15, 2013DoubleTree by Hilton San Diego/Mission Valley • San Diego, CAwww.IBCLifeSciences.com/CoursesCell Line Development & EngineeringMay 20-22, 2013 • Hyatt Regency La Jolla at Aventine • La Jolla, CAwww.IBCLifeSciences.com/CellLineJune 2013Single-Use Applications forBiopharmaceutical ManufacturingJune 3-5, 2013 • Durham Convention Center • Durham, NCwww.IBCLifeSciences.com/SingleUseVaccine Development & Production SummitJune 3-5, 2013 • Durham Convention Center • Durham, NCwww.IBCLifeSciences.com/VaccinesApplications for Enzyme TechnologiesJune 17-18, 2013 • Hotel Nikko San Francisco • San Francisco, CABioprocess Training AcademyJune 12-13, 2013 • Le Méridien Cambridge-MIT • Cambridge, MAwww.IBCLifeSciences.com/CoursesNext Generation Protein Therapeutics SummitJune 26-28, 2013 • Hotel del Coronado • Coronado, CAwww.IBCLifeSciences.com/ProteinSummitBioconjugates: From Targets to TherapeuticsJune 26-28, 2013 • Hotel del Coronado • Coronado, CAwww.IBCLifeSciences.com/BioconjugatesBioProcess International Conference &Exhibition CHINAAugust 20-21, 2013 • Shanghai, Chinawww.IBCLifeSciences.com/BPIChinaSeptember 2013BioProcess International Conference & ExhibitionSeptember 16-20, 2013 • Boston, MAwww.IBCLifeSciences.com/BPIFormulation Strategies for Protein TherapeuticsSeptember 17-18, 2013 • Boston, MAwww.IBCLifeSciences.com/FormulationCell Therapy BioprocessingCo-Located with IBC’s Inaugural Conference on:Gene Therapy BioprocessingWashington, D.C.www.IBCLifeSciences.com/CTBOctober 2013Well Characterized BiologicalsCo-Located with IBC’s Inaugural Conference on:Product & Process Variants & ImpuritiesOctober 21-23, 2013 • L’Enfant Plaza Hotel • Washington DCwww.IBCLifeSciences.com/WCBNovember/December 2013Antibody Engineering & Antibody TherapeuticsDecember 8-12, 2013 • Huntington Beach, CAwww.IBCLifeSciences.com/AntibodyEngBiopharmaceutical Development & Production Week 27