Cell Culture & Upstream Processing - IBC Life Sciences

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Monday, September 22, 2008 • Pre-Conference Workshops Workshop A Technology Transfer for Biopharmaceuticals 1:00 Chairperson’s Opening Remarks Eric Ford, Manufacturing Technical Specialist, Late Stage Process Development, Genentech, Inc. 1:10 Effective Data Management for Technology Transfer James Myers, Ph.D., Process Engineer, Engineering Science, Avecia Biologics Ltd., United Kingdom 1:50 Achieve Full Integration of the Technology Transfer Process across Process Development through to Filing Patrick J. Watters, Principal Project Manager, Biotech Technology and Engineering, Wyeth Biotech 2:30 Refreshment Break 3:00 Challenges of International Transfers Siddarth J. Advant, Ph.D., Principal, Tunnell Consulting 3:40 Challenges Faced During Optimization and Transfer of Legacy Processes Eric Ford, Manufacturing Technical Specialist, Late Stage Process Development, Genentech, Inc. 4:20 Audience Interactive Panel Discussion 5:00 Close of Workshop Workshop B Single Use Bioprocess Systems: Intensive Update 1:00 Chairperson’s Opening Remarks Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences; Director and Chair, Technology Committee, Bio-Process Systems Alliance 1:10 Regulatory Requirements for Manufacturing and Validation of Single-Use Systems Andrew Sette, Director of Quality and Regulatory Affairs, Sartorius-Stedim Biotech, France 1:50 Evaluation of Bioreactors and Single-Use Bioprocessing Supplies Leigh N. Pierce, President, PacificGMP 2:30 Advances in Disposable-Format Downstream Processing Technologies Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. 3:10 Refreshment Break 3:40 Analyzing the Carbon Footprint Left by a Company’s Use of Disposables Lindsay Leveen, Associate Director Strategic Planning and Lytics CMC Team Lead, Genentech, Inc. 4:20 Working with Vendors – Setting up GMP Supplier Relationships under GMP Hélène Pora, Ph.D., Senior Director, Single-Use Systems, Pall Life Sciences, France 5:00 Audience Interactive Panel Discussion 5:30 Close of Workshop Workshop C Process Characterization and Monitoring During Development & Commercialization of Biopharmaceuticals 1:00 Chairperson’s Opening Remarks Siddharth J. Advant, Ph.D., Principal, Tunnell Consulting 1:10 Use of Statistical Tools during Process Characterization Jason Kamm, Managing Consultant, Tunnell Consulting 1:50 Development of Scale Down Models to support Process Validation for Cell Culture Processes Helena Yusuf-Makagiansar, Ph.D., Associate Director, Biopharmaceutical Development, Biogen Idec 2:30 Refreshment Break 3:00 Industrial Experiences with the Continuum of Process Characterization, Validation & Process Monitoring During/Postcommercialization Neslihan DelaCruz, Principal Engineer, Amgen Inc. 3:40 Quality by Design: A Biologics Case Study in Formulation & Process Development Carol F. Kirchhoff, Senior Principal Scientist, Pfizer Inc 4:20 Interactive Panel Discussion 5:00 Close of Workshop From Climbing to the Top of the Earth to Launching into Orbit… …BioProcess International 2008 brings you inspiration for the future of a streamlined industry with keynote presentations by visionaries who have climbed the highest mountains, surmounted physical challenges to achieve world endurance records, and supported the launch of NASA shuttles and spacecraft… …But remains fully grounded in nuts and bolts case studies from biopharmaceutical industry speakers that will help you bring back new tips that can improve your processes tomorrow, while you plan for the coming decade’s changes. (See pages 6, 8 & 10 for complete abstracts) Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event 5
Tuesday, September 23, 2008 • Main Conference 1 Production & Economics of Biopharmaceuticals 2 Scaling Up from Bench through Commercialization 7:00 Registration and Coffee Strategic Planning for Biopharmaceuticals: Challenges for a Maturing Industry 8:00 Chairperson’s Remarks Joanne T. Beck, Ph.D., Plant Manager, Abbott Bioresearch Center 8:15 Keynote Presentation How to Motivate Staff to Implement Lean Manufacturing to Raise the Bottom Line Experience from over 1,000 process improvements has demonstrated the elements necessary for success of a lean program: passionate executive sponsor, endorsed project charter, engaged team, and a phased approach with realistic goals. Gain strategic tips for incorporating value stream mapping, design of experiments (DOE), mistake-proofing, failure modes and effects analysis (FMEA), Root Cause/Risk Analysis, statistical process control (SPC), process mapping, process management performance metrics, trend analysis, process re-engineering, analysis of variation (ANOVA), benchmarking and more. Rob Bryant, MBA, Vice President, Quality, Lean/Six Sigma Program Lead Master Blackbelt, Computer Sciences Corporation 8:45 Case Studies in Using Lean Six Sigma to Drive Optimization and Significant Financial Benefit Lean Six Sigma can be creatively applied to significant business opportunities to yield better and faster business outcomes. This presentation will review case study examples of the use of Lean Six Sigma to drive optimization and significant financial benefits for some common manufacturing business initiatives. Beth Whitacre, Quality Control Team Leader, Certified Six Sigma Black Belt, Eli Lilly and Company 9:15 Process Economics and Life-Cycle Management Challenges to the Development and Manufacturing of Orphan Drugs: A Review of our Naglazyme Experience The process economics and life-cycle management of ultra-orphan biologics will differ greatly from larger market drug products. Patient accrual numbers and drug demand for clinical, launch and lifetime supply will shape strategies for process development, clinical production and qualification stages leading to launch. In this talk we will discuss these and other challenges unique to small market products. Jonathan Blackie, Director, Manufacturing, BioMarin Pharmaceutical Inc. 9:45 Networking Refreshment Break 10:15 Concentration and Dispersion in a Global Industry: The Geography of Biomanufacturing Based on data collected since 2000, this presentation will examine trends in the location of biomanufacturing capacity, specifically for mammalian cell culture production. Many factors influence companies’ location decisions: firm size and stage of development, product and technology maturity, and public policy. This research will posit some hypotheses as to what is driving the location dynamics of this industry. Elisabeth Reynolds, Industrial Performance Center, Massachusetts Institute of Technology 10:45 Streamlining Technology Transfer of Biomolecules to CMO's Jose M. Hanquier, Principal Research Scientist, Large Molecule Outsourcing MS&T Leader, Eli Lilly and Company 11:15 Managing a Biologics Supply Chain Using A Fully- Outsourced Manufacturing Model Millennium has managed the supply of several different biologics at all stages of clinical development using a fully outsourced manufacturing model including drug substance, drug product and release assays. Experiences related to process transfer and documentation, facility fit, demand planning and validation activities for launch will be presented. The importance of maintaining a fully functional internal process development group and pilot plant will be emphasized. Michael W. Glacken, Ph.D., Director of Biologics Process Development, Millennium Pharmaceuticals, Inc. 7:00 Registration and Coffee Strategic Scale Up Decisions to Accelerate Process Development 8:00 Chairperson’s Remarks Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen Inc. 8:15 Knowledge Management at the Jet Propulsion Laboratory: Reuse for Innovation, Process Improvement, and Risk Reduction Knowledge Management (KM) Systems offer the potential to increase innovation, improve processes, and reduce risk. Realizing this potential, however, requires careful attention to people, processes, and products. This presentation synthesizes results from KM research and practice at JPL in our quest to explore our solar system and beyond, and offers suggestions for application to biopharmaceutical production. Lynne Cooper, Ph.D., Knowledge Strategist, Office of Opportunity Development, Jet Propulsion Laboratory, California Institute of Technology 8:45 Knowledge Management Supporting QbD Regulatory Submissions Quality by Design (QbD) is an initiative aimed at streamlining process development efforts required to license a new product and Regulatory submissions required during a product’s lifecycle without sacrificing safety and efficacy. A key element of QbD is leveraging pre-existing data from similar molecules to facilitate establishing a design space. This presentation will provide an overview of the knowledge management approach Genentech will be taking as part of its implementation of QbD. Ron Taticek, Ph.D., Associate Director, CMC Regulatory Affairs, Genentech, Inc. 9:15 Data Management Systems Facilitating Successful Root Cause Analysis in Cell Culture Production Processes Scale-up of cell culture production processes and their consistent performance in manufacturing present challenges due to their high level of complexity and the large number of process parameters involved. Large data management systems can capture and present the process data, but for their analysis and meaningful interpretation, the input from process experts is needed. A process was put in place to link the data management and data interpretation function to successfully identify root causes for process scale-up and consistency issues. Bernhard M. Schilling, Ph.D., Group Leader, Manufacturing Sciences, Bristol-Myers Squibb Company 9:45 Networking Refreshment Break 10:15 Design for Manufacturability in the Development of a Seamless Monoclonal Antibody Process Removal of intermediate steps between unit operations of biological purification processes lowers cost, simplifies operations and facilitates technical transfer. The development of a seamless process for purification of a monoclonal antibody and the tools used to improve the manufacturability and technical transfer will be discussed. Communication between Development and Manufacturing regarding criticality of timelines, data and problem solving will be presented. Pedro J. Alfonso, Ph.D., Associate Director, Centocor R&D, Inc. 10:45 Developing Production Platforms for a Portfolio Approach: A Case Study in the US and Ireland To maximize the value of a robust and varied portfolio, processes must be inherently robust to facilitate technology transfer. Recent examples of the integration of multiple groups with a common goal illustrate the challenges and accomplishments of deliberately limiting options while maximizing the probability of success. E. Morrey Atkinson, Ph.D., Director, Bioprocess Research and Development, Eli Lilly and Company 11:15 Audience Interactive Panel Discussion Platform Development: Leveraging Informational Sciences to Compound and Use Process Performance Characterization Data Moderator: Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen Inc. Panelists will include all morning session presenters. 6 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Page 1 and 2: THE Meeting Place for the Bioproces
Page 3 and 4: September 23-26, 2008 Disneyland®
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Page 9 and 10: Tuesday, September 23, 2008 • Mai
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Page 19 and 20: Co-Located Conference IBC’s 8th A
Page 21 and 22: The Largest Display of New Products
Page 23 and 24: Call for Poster Submissions Submit

Cell Culture & Upstream Processing - IBC Life Sciences

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