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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Verification in the NewParadigm (continued)Analytical TechnologiesProduct-Related Variants andImpuritiesCASE STUDY • UNPUBLISHED DATA ProteinPrecipitation During UF/DF – IsConcentratability a Problem with My Molecule?Bernice Yeung, Ph.D., Director, Analytical andFormulation Development,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Richter, Ph.D., Lab HeadDSP Development Cell Culture, SandozBiopharmaceuticals GmbH, AustriaCASE STUDY • UNPUBLISHED DATA MeasuringColor and Understanding Color DifferencesAssociated with Process ChangesChristopher Yu, Ph.D., Scientist, Protein AnalyticalChemistry, Genentech,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