Conference • Tuesday, October 2, 2007 - IBC Life Sciences

Main Conference • Thursday, October 4, 2007 (continued)Cell Culture & Upstream ProcessingRecovery & Purification3 410:45 Topic and presenter to be determined11:15 The Application of Root Cause Analysis andInvestigational Tools to Identify and Resolve CellCulture Issues Observed at Commercial Scale duringTechnology TransferUnexpected cell culture performance was observed during the transfer and scaleup of a commercial scale process to 15,000L. This presentation discusses theapplication of root cause analysis and investigational tools to identify and resolvethe process issues. The investigational tools include multivariate data analysis,computational fluid dynamics, bench and pilot scale evaluation.Kenneth Green, Ph.D., Principal Scientist, Amgen Inc.11:45 Concurrent Technology WorkshopsNext Generation Process Control10:45 A Systematic Approach for Process Improvementvia Process Data Analysis: Example for ImprovingUFDF Recovery EfficiencyCaseStudyIn a biological manufacturing process, a large number of process variables are typicallymonitored. These data can be used to increase process efficiency and improve stability.In this work, an approach is presented to systematically analyze process data forimproving the efficiency and operation consistency of an ultrafiltration/diafiltration(UFDF) process step which is used to concentrate a purified protein product.Michael J. Bartkovsky, Ph.D., Process Engineer, BioPharma Group, BayerTechnology Services, Bayer Corp.11:15 Process Characterization during Development and ValidationDriven by competitive and regulatory compliance demands, there is increasingemphasis to optimize including process identification, process validation, processcontrol, and process improvement throughout process development. Thispresentation describes statistical techniques that are used to identify critical processcharacteristics. Topics include design of experiments and analysis of variance.Steven Walfish, M.S., President, Statistical Outsourcing ServicesProcess Optimization Using Peptones – CaseStudies Demonstrating Increased PerformanceWith Peptone Blends and Feed StrategiesOne of the most important factors in any production processis the selection of an appropriate base medium that is coupledwith an effective feed strategy. Animal Free peptones havebeen successfully used to achieve increased production levelswith minimal cost and timeline requirements. Several casestudies will be shown in this presentation where significantproduction improvements were achieved through the use ofpeptone blends or an appropriate peptone feeding strategy.Stacy Holdread, M.S., Senior Scientist, R&D, BDBiosciences – Advanced BioprocessingAbstract and speaker nameunavailable at press time.Please visit www.IBCLifeSciences.com/BP/USfor program updates.Preview of a Novel and Robust Viral Clearance Solutionfrom MilliporeThis workshop will provide a preview of Viresolve® Pro, a novel virus clearancesolution under development at Millipore. It combines a high capacity/highflux virus filter with a high level of parvovirus retention and novel intergritytesting technology. Case studies will be presented, with virus clearance resultsthat demonstrate the anticipated performance of Viresolve Pro devices. Thisinformation is critical for process development scientists and manufacturingengineers who are looking for effective and efficient virus clearance solutions.Inese Lowenstein, Group Product Manager, Virus Clearance, Bioprocess R&D,Millipore CorporationMani Krishnan, Program Manager - Virus Clearance, Bioprocess R&D,Millipore CorporationSal Giglia, R&D Manager, Bioprocess R&D, Millipore Corporation12:15 Luncheon and Technology WorkshopSponsored by:Integration, Implementation and Validation of Single-use Bioprocessing TechnologiesSingle use disposable technology is a proven alternative solution for the biopharmaceutical industry (upstream, downstream, formulation and filling) offeringseveral significant advantages over standard reusable stainless steel systems. Key factors for successful single use system integration are: Process Knowledge,Experience with Single Use Systems, Single Use Product Portfolio offering, Strong Technical Capability, Full Documentation Package, Validation SupportMonica Cardona, Marketing Manager, Pall Life SciencesCell Culture & Upstream ProcessingRecovery & Purification3 41:30 Chairperson’s RemarksSuzanne Kuo, Ph.D., Senior Engineer, Late Stage Cell Culture ProcessDevelopment, Genentech, Inc.Commercial Process Readiness, Troubleshootingand Improvements1:45 BioProcessing Challenges for Large ScaleDisposable BioreactorsDisposable bioreactors have been shown to be effective in performing batch,fed-batch and continuous cell culture processes. At large scale, the traditionaland expected challenges arise such as oxygen transfer, CO2 removal andadequate mixing time for addition of nutrients and pH control fluids. Large scaleperfusion operation presents the most extreme challenges including volumecontrol, steady feed addition, harvest removal, cell recycle and maintenance ofsterile operations in a more complex large scale system. The presentation willhighlight these challenges at large scale and will present data from a case study.Jin Yin, Senior Bioengineer, Shire Human Genetic Therapies, Inc.Geoffrey Hodge, Vice President, Process Development and Technology,Xcellerex Inc.1:30 Chairperson’s RemarksChris Dowd, Ph.D., Senior Engineer, Late Stage Purification, Genentech, Inc.Novel Process Development Strategies1:45 Process Development Strategy for High-Concentration UF/DF of MAbsProducing antibody products formulated at high concentrations is useful todeliver adequate product in small injection volumes. However, at large scalethis may be a challenge. In this presentation we will describe a well-definedexperimental approach to optimizing and scaling up the ultrafiltration/diafiltration step for the concentration and formulation step used inmanufacturing processes to produce antibody products. We have developeda robust, scalable UF/DF step that allowed us to produce clinical supplies atproduct concentrations up to approximately 125 g/L of protein. We will alsoshare observations made during the development of the diafiltration step.The experimental results for diafiltration will be presented along with theexpected theoretical trends and values for pH, conductivity, osmolarity, andconcentrations of components in the diafiltration buffer.Robert G. Luo, Ph.D., Senior Scientist, Purification Sciences, Human GenomeSciences, Inc.18 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event