Program Information - IBC Life Sciences

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Thursday, September 23, 2010 (continued) 12:00 Concurrent Technology Workshops Room 550 Hybrid Purification – The Next Generation of Cell Clarification Centrifuge Replacement Via Single-Use Depth Filtration in Cell Culture Clarification This workshop will explore the use of single-use depth filtration technology and its implementation in cell clarification, primarily as a tool to replace conventional centrifuges. Encapsulated Zeta Plus disposable depth filters represent the latest product innovation from 3M Purification Inc. and its features and benefits will be highlighted during this session. Thomas P. O’Brien, Ph.D., Senior Scientific Applications Support Specialist, 3M Purification Inc. Room 553 Cell Culture Media Platform for the Rapid Production of Gram Quantities of Recombinant Antibodies from CHO Cells Transformed with the Selexis Vectors Results from a collaborative program between Irvine Scientific, CA., USA and Selexis, S.A., Geneva, Switzerland will be presented. Tom Fletcher, Director, Cell Culture R&D, Irvine Scientific Pierre-Alain Girod, Ph.D., Chief Scientific Officer, R&D, Selexis SA, Switzerland Room 551 Multi-Fold Titer Improvement through Integrated Medium and Feed Design High cell densities and product yields require culture media and feeds formulated so that no one nutritional component becomes limiting. Integration of the basal medium and feed design ensures nutrient availability. IgG titers of 2.6 g/L were reached using an integrated design strategy compared with starting titers of 0.5 g/L. This represents a 10-fold improvement over batch culture. Potential challenges and solutions will be discussed. Shawn Barrett, Senior Manager, R&D, Invitrogen, part of Life Technologies Room 552 POROS® XS: A High Capacity, High Resolution CEX Resin The features and performance of POROS® XS chromatography resin will be highlighted. The benefits of a high capacity, high resolution, salt tolerant CEX resin as they relate to improving downstream purification process performance and productivity will be proposed. Applications data and process productivity modeling will be used to demonstrate the benefits of utilizing POROS XS. Christine Gebski, M.S., Director, POROS Applications and R&D, Applied Biosystems, part of Life Technologies 12:30 Networking Luncheon in Exhibit and Poster Hall 1:00 Featured Presentation in Exhibit and Poster Hall The Enduring Need for Operational Excellence: Lessons Learned from the Oil Field to Biotech and How Great Companies can Still Fall Short BP’s oil disaster in the Gulf shows how decisions and events can impact global organizations. Genzyme was hit with a virus that was undetectable by the industry’s standard viral tests and led to a global shortage in supply of critical medicines. During this presentation, Mark Bamforth will reflect on the importance of relentlessly pursuing operational excellence and how events can still impact an organization. Mark R. Bamforth, President & CEO, Gallus Biopharmaceuticals; Former Senior Vice President, Corporate Operations and Pharmaceuticals, Genzyme Corporation Recovery & Purification (Ballroom B/C) 1:45 Chairperson’s Remarks Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany Implementing the Latest Tools and Techniques to Optimize the Harvest Step 2:00 Optimization of the Harvest Step Roy Hegedus, Ph.D., Senior Scientist, Purification, Process Sciences, Abbott Bioresearch Center 2:30 Enabling Precipitation as an Operation to Manage Critical Contaminants in Bioprocessing Daniel G. Bracewell, Ph.D., M.S., Department of Biochemical Engineering, University College London, United Kingdom 3:00 Exploring Expanded Bed Adsorption for Capture of Antibodies from CHO Cultures Richard S. Wright, Principal Research Scientist, Pfizer Biotherapeutics 3:30 Networking Refreshment Break, Last Chance for Exhibit and Poster Viewing Overcoming Challenges of Production, Purification and Characterization of Next Generation Antibody-Like Molecules & Protein Therapeutics 4:00 CASE STUDY Investigation into the Concentration Limit of a PEGylated Protein Sarah Holtschlag, M.S., Senior Scientist, Downstream Process Development, Diosynth Biotechnology, now a part of MERCK BioManufacturing Network 4:30 Assembly and Purification of Knob and Hole Bispecific Antibodies Josefine Persson, Ph.D., Scientist, Early Stage Purification, Genentech, Inc. 5:00 Applications for Biopharmaceuticals in Regenerative Medicine Peter W. Wojciechowski, Ph.D., Director, Product and Process Development, Advanced Technologies and Regenerative Medicine, LLC (ATRM) 5:30 Immunodrugs TM – Development of a New Class of Therapeutic Vaccines Frank Hennecke, Ph.D., Executive Vice President, Product Development, Cytos Biotechnology, Switzerland 6:00 Close of Day Cell Culture & Upstream Processing (Ballroom D/E) 1:45 Chairperson’s Remarks Kevin J. Kayser, Ph.D., Associate Director, Cell Sciences and Development, SAFC Host Cell Engineering to Improve the Yield and Quality of Biotherapeutics 2:00 Proven Approaches to Determine Manufacturability of Candidate Molecules Czeslaw Radziejewski, Ph.D., Senior Group Leader, Protein Analytics, Abbott Bioresearch Center 2:30 Profiling Highly Conserved MicroRNA Expression in Chinese Hamster Ovary Cells and Its Applications in Cell Engineering Nan Lin, Principal R&D Scientist, Cell Sciences and Development, Sigma-Aldrich 3:00 Use of RNAi to Transform Biotherapeutics David Kocisko, Ph.D., Principal Scientist, Alnylam Biotherapeutics 3:30 Networking Refreshment Break, Last Chance for Exhibit and Poster Viewing Implementation of Novel Media Development and Feed Strategies 4:00 CASE STUDY Learning from High-Performance Chemically- Defined Media Formulations for CHO Platform Processes Masaru Shiratori, Ph.D., Engineer II, Late Stage Cell Culture, Genentech, Inc. 4:30 How Media Optimization Impacts Quality Zhaohui Geng, M.D., M.S., Principal Scientist, Cell Process Development, Pfizer Biotherapeutics 5:00 From Hydrolysates to Unique Molecules: Identification of Bioactive Components Elizabeth Dodson, Ph.D., R&D Manager, BioAnalytical Chemistry Bionutrients R&D, BD Biosciences - Advanced Bioprocessing 5:30 Chemically-Defined Cell Culture Platform Development for Therapeutic Antibody Production. John Fann, Ph.D., Senior Group Leader, Cell Culture, Process Sciences, Abbott Bioresearch Center 6:00 Close of Day 16 www.IBCLifeSciences.com/BPI
Friday, September 24, 2010 7:30 Coffee Recovery & Purification (BallroomB/C) 8:00 Chairperson’s Remarks Günter Jagschies, Ph.D., Senior Director, Strategic Cusatomr Relations, GE Healthcare Life Sciences, Sweden Evaluation and Implementation of Next Generation Purification Technologies 8:15 CASE STUDY Strategies to Address Clarification of High Concentration Refold Pools for E. coli Based Therapeutics Xuankuo Xu, Ph.D., Scientist, Process Science Downstream, Bristol-Myers Squibb 8:45 Downstream Process Continuous Improvement – Meeting High Titer mAb Production Demands Diane D. Dong, Ph.D., Senior Scientist II, Technical Operations, Abbott Bioresearch Center 9:15 Bioengineered Protein A Polymer Beads for High-Affinity Antibody Purification Bernd H. A. Rehm, Ph.D., Chief Scientific Officer, PolyBatics Ltd., New Zealand 9:45 Networking Refreshment Break Process Characterization for Developing Design Space 10:15 Challenges of Technology Transfer Exacerbated by a Small Scale Model Artifact Marcus P. Luscher, Scientist, Purification Process Development, Amgen Inc. 10:45 CASE STUDY Accelerated Methionine Oxidation Due to Viral Filtration A Case Study of the Limitations of Small Scale Models Tom Strickland, Ph.D., Principal Scientist, Purification Process Development, Amgen Inc. 11:15 CASE STUDY Downstream Process Characterization for a Highly Glycosylated Fc-Fusion Protein Canping Jiang, Ph.D., Senior Scientist, Manufacturing Sciences and Technology, Bristol-Myers Squibb 11:45 CASE STUDY Developing and Characterizing a High Concentration Ultra-Filtration Process Kelby Lau, Engineer II, Process Development – Late Stage Purification, Genentech, Inc. Cell Culture & Upstream Processing (Ballroom D/E) 8:00 Chairperson’s Remarks Denny Kraichely, Ph.D., Associate Director, CMC Team Lead, Portfolio Management & Technical Integration, Johnson & Johnson Pharmaceutical R&D, Inc. What Comes Next After Titer Increase 8:15 The Next Challenge(s) in Bioprocess Development Martin S. Sinacore, Ph.D., Site Head, Cell Culture Development, Biogen Idec 8:45 Investigating Mammalian Cell Physiology using ‘Omics’ Tools Karthik P. Jayapal, Ph.D., Process Development Scientist, Cell Culture Development, Bayer HealthCare 9:15 Taking a Leap Off the Platform: Reducing Timelines to Meet New Challenges Jim Mercer, Principal Engineer I, Culture Process Development, Pfizer Biotherapeutics 9:45 Networking Refreshment Break Featured Presentation 10:15 An Industrial View of Biopharmaceutical Comparability and Characterization Anthony S. Lubiniecki, Sc.D., Senior Fellow, CMC Strategy, Large Molecule Portfolio Management, Janssen Pharmaceutical Companies of Johnson & Johnson Approaches to Improve Product Quality and Achieve Process Optimization 10:45 CASE STUDY A Research Strategy to Enhance mAb Product Quality and Productivity in CHO Cell Culture Process Min Zhang, Ph.D., Senior Research Scientist, BioProcess R&D, Eli Lilly and Company 11:15 CASE STUDY Maintaining Product Quality and Process Optimization from Early to Late Stage Process Development Jason Goodrick, M.S., Senior Engineer, Late Stage Cell Culture, Genentech, Inc. 11:45 CASE STUDY QbD Approach to Cell Culture Process Characterization: A Case Study for a Monoclonal Antibody Production Process Szu-Han Wang, Engineer I, Late Stage Cell Culture, Pharma Technical Development, Genentech, Inc. Room 551 Improving Biomanufacturing Efficiency through Recombinant Solution The current requirement for the biomanufacturing industry is to shorten the time taken to deliver new drugs to the market and reduce overall costs while maintaining regulatory compliance and product quality. During this workshop, Novozymes will discuss how the introduction of innovative technologies and products, such as recombinant protein solutions, and ongoing collaborative dialogue with the manufacturer is helping to drive efficiency improvements across the product lifecycle. Dr. Anthony Simula, General Manager, Novozymes Biopharma, Australia 12:15 Technology Workshops Room 552 Simple, Innovative Technology Reduces Testing Complexity and Streamlines Bioprocessing Operations This case study details how a leading protein processing facility, Diosynth Biotechnology, implemented microvolume UV-Vis testing at critical points in the workflow to greatly reduce processing time and increase efficiency. NanoDrop microvolume UV-Vis spectrophotometers are simple tools which can be easily implemented throughout a processing organization including R&D, manufacturing and quality control with great impact on the entire workflow and on debottlenecking steps. Philippe Desjardins, Scientific Marketing Manager, Thermo Scientific NanoDrop Products 12:30 Lunch on Your Own Room 553 Full Plastics - A Comprehensive Study on Using Single-Use Strategies for Generic Mab Manufacturing Using Total Disposable Technology The consistent and integrated use of disposable technologies enables a fast and reproducible GMP manufacturing and allows a substantial cost cutting for clinical supply. A comparative study on commercially available single-use technologies will be presented providing an in-depth cost comparison with conventional non-disposable facilities. Data from different stirred single-use bioreactor systems regarding operability and process kinetics at 250-L scale will be supplied as well as cell separation capacities assigned for using as disposable state-of-the-art filtration units. The integration of disposable downstream technologies will be discussed. Dethardt Müller, Ph.D., Rentschler Biotechnologie GmbH, Germany Gregor Dudziak, Ph.D., Vice President, Cell Culture, Rentschler Biotechnologie GmbH, Germany Enhance Your Conference Experience with twitter.com/ibcbioprocess • Follow @ibcbioprocess on Twitter for special offers and news from the event. • Monitor the #bpiconf topic to connect with others at the event. • End your Tweets from the event with #bpiconf to join the conversation. BioProcess International Conference & Exhibition 17
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Program Information - IBC Life Sciences

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