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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Can We Expect?Dayue Chen, Ph.D., Research Advisor, ProcessDevelopment, Eli Lilly and CompanyCASE STUDY • UNPUBLISHED DATA How Do YouImplement Aspects of the Facility of theFuture in Current Facilities?Paul Jorjorian, M.S., Manager, PurificationDevelopment, Gallus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Consultants, Inc.10:00 Networking Refreshment Break in Exhibit and Poster HallContinuous Processing Systems10:45 UNPUBLISHED DATA The Potential forContinuous Chromatography in ClinicalManufacturing of BiopharmaceuticalsThomas C. Ransohoff, M.S., Vice President andSenior Consultant,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