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Monday, September 20, 2010 1:00 pm - 5:00 pm Symposium #1: Prevention of Microbial and Viral Contamination of Mammalian Cell Culture Processes - Lessons Learned and Case Studies Tuesday, September 21, 2010 Morning Managing Manufacturing Networks Leveraging our Assets - How do We Reconcile the Installed Base with Current Technologies and Demand Leveraging our Assets - How do We Reconcile the Installed Base with Current Technologies and Demand (session continues) Product Lifecycle Management Process Design: Establishing Design Space and Robust Process Parameters Process Design: Establishing Design Space and Robust Process Parameters (session continues) Agenda Overview Symposium #2: How Much Data is Enough The Statistical Approach to Process Validation Networking Refreshment Break Sponsored Session by Bio-Rad Strategic Discussion Forum Advancements and Case Studies of Hydroxyapatite for Biomanufacturing Advancements and Case Studies of Hydroxyapatite for Biomanufacturing (session continues) 11:45 am Technology Workshops Sponsored by: Sheffield Bio-Science, Mirus Bio and Novasep 12:15 pm Luncheon Presentation by Millipore Afternoon Smart Flexibility in Facilities Implementation and Execution Networking Refreshment Break Opening Keynote Presentations: I. Regulatory Modernization - FDA's Desired State for Product Quality II. The Role of Biosimilars in Driving Innovation in the Biopharmaceutical Industry Symposium #3: Technology Transfer for Biopharmaceuticals Managing Partners and Contractors – Practical Solutions to the Issues that Arise Manufacturing: What will Take us to the Next Level of Efficiency and Economics Sponsored by Pall Life Sciences 5:30 pm Opening Night Reception Sponsored by Pall Life Sciences in the Exhibit and Poster Hall Wednesday, September 22, 2010 Managing Manufacturing Networks Product Lifecycle Management Raw Materials/ Supply Chain Strategic Discussion Forum Recovery & Purification Rapid Vaccine Development and Production 7:15 am Technology Workshop with Continental Breakfast Sponsored by: SAFC Biosciences Keynote Presentation: Global Vaccine Production Challenges: Emerging Morning The Future of Manufacturing Networks and Facilities The Future of Manufacturing Networks and Facilities (session continues) Continuous Process Improvement Continuous Process Improvement (session continues) Point Counterpoint Session: Integrating Raw Materials and Suppliers into a Pharmaceutical Quality System Advances in Process Monitoring and Control in Downstream Processing Networking Refreshment Break Sponsored by Luminex in Exhibit and Poster Hall Point Counterpoint Session: Integrating Raw Materials and Suppliers into a Pharmaceutical Quality System (session continues) Continuous Disposable Multi-Column Chromatography: Emerging Technology to Enable More Efficient Downstream Processing - Sponsored by Tarpon Biosystems Cell Culture & Upstream Processing Integrating In-Line Process Monitoring and Control Technologies in Upstream Processing 12:00 pm Technology Workshops Sponsored by: Diosynth Biotechnology, GE Healthcare, Natrix Separations Inc., and New Brunswick Scientific 12:30 pm Networking Luncheon in Exhibit and Poster Hall with Dedicated Poster Viewing Afternoon Plenary Session – Critical Industry Issues Networking Refreshment Break Sponsored by Luminex in Exhibit and Poster Hall Keynote Presentations: I. Sustainable Commercial Cell Culture Operations II. Finding a Home for Process and Product Development 5:30 pm Networking Reception in Exhibit and Poster Hall Sponsored by BD Biosciences Thursday, September 23, 2010 Recovery & Purification Cell Culture & Upstream Processing Emerging Analytical Requirements 7:15 am Technology Workshop with Continental Breakfast Sponsored by: BD Biosciences Morning Plenary Session - Integration of Upstream and Downstream Processing Breakthroughs to De-Bottleneck Downstream Processing Accelerating & Optimizing Cell Line & Process Development Emerging Analytical Requirements and their Impact on Process Development and Manufacturing Networking Refreshment Break in Exhibit and Poster Hall Emerging Analytical Requirements and their Impact on Process Development and Manufacturing (session continues) Immunotherapeutics, Manufacturing Flexibility and Reducing COGS Lessons Learned from the 2009 Flu Season to Guide Rapid Vaccine Development and Manufacturing Scale Up Process Development for Novel Vaccines and Immunotherapeutics Defending Biosimilar Competition: Bioprocess IP Protections for Next Generation Vaccines and Immunotherapeutics Process Development and Analytical Characterization for Vaccine Production Process Development and Analytical Characterization for Vaccine Production (session continues) Strategic Discussion Forum Smart Flexibility: What Creates the Right Degree of Flexibility and Cost Reduction in Different Phases of Manufacturing 12:00 pm Technology Workshops Sponsored by: 3M Purification Inc., Irvine Scientific, Applied Biosystems, a part of Life Technologies, and Invitrogen, a part of Life Technologies 12:30 pm Networking Luncheon in Exhibit and Poster Hall with Dedicated Poster Viewing Formulation Strategies for Protein Therapeutics Pre-Conference Workshop: The Formulator of the Future: Using High Throughput Technologies, Informatics and Rational Design to Accelerate and Optimize Formulation Development Keynote Presentations: Holistic QbD; Particles, Particles Everywhere Development of Formulation and Drug Product Design Space Comparability and Characterization Exercises during Formulation Development Comparability and Characterization Exercises during Formulation Development (session continues) Technology Workshop Formulation Strategies for Protein Therapeutics Keynote Presentation: Modeling Protein Degradation Processes and the Development of Rational Approaches to Stabilization Keynote Presentation: NIST Perspective on Standards and GMP Processes for Subvisible Particles in Protein Therapeutics Implementing Analytical Methods and Control Steps for Subvisible Particles Technology Workshop Evaluation and Control of Biopharmaceutical Stability Evaluation and Control of Biopharmaceutical Stability (session continues) Formulation Strategies for Protein Therapeutics Formulation Strategies for Vaccines Formulation Impacts of Device and Packaging Systems 1:00 pm 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 Implementing the Latest Tools and Techniques to Optimize the Harvest Step Host Cell Engineering to Improve the Yield and Quality of Biotherapeutics Development and Manufacturing Strategies for Biosimilars Products Formulation Development for Next Generation Biologics Afternoon Overcoming Challenges of Production, Purification and Characterization of Next Generation Antibody-Like Molecules & Protein Therapeutics Friday, September 24, 2010 Networking Refreshment Break in Exhibit and Poster Hall (Last chance to consult with suppliers and view posters) Implementation of Novel Media Development and Feed Strategies Site Tour to Amgen’s BioNext Facility (space is limited) 3:00 pm Conference Ends Recovery & Purification Cell Culture & Upstream Processing Evaluation and Implementation of Next Generation Purification Technologies What Comes Next after Titer Increase Morning Networking Refreshment Break Process Characterization for Developing Design Space Featured Presentation: An Industrial View of Biopharmaceutical Comparability and Characterization Approaches to Improve Product Quality and Achieve Process Optimization 12:15 pm Technology Workshops Sponsored by: Novozymes Biopharma, Thermo Scientific NanoDrop Products, Rentschler Biotechnologie GmbH 12:45 pm Lunch on your own Afternoon Utilizing Continuous Processing to Decrease Operation Time and Improve Facility Utilization Applications of Automated, High-Throughput Technologies in Downstream Processing Networking Refreshment Break Advantages of Using Mixed Mode Technologies Overcoming Challenges of Producing Specific Proteins Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event 4
Monday, September 20, 2010 • Pre-Conference Symposia 12:00 Registration Symposium #1: Prevention of Microbial and Viral Contamination of Mammalian Cell Culture Processes - Lessons Learned and Case Studies 1:00 Chairperson’s Remarks Robert D. Kiss, Ph.D., P.E., Director, Late Stage Cell Culture - Pharma Technical Development, Genentech, Inc. 1:15 How to Prevent Microbial Contaminations of Bioreactors, and Successful Strategies for Addressing Them if/when They Occur Andrew Brewer, Senior Engineer, Biologics Manufacturing Science and Technology, Genentech, Inc. 1:45 CSI GMP Production; Lessons from the Contamination Scene Katie Stewart, M.S., Technical Training Supervisor, Technical Training, Human Genome Sciences Inc. 2:15 CASE STUDY Microbial Contamination in a CHO Based Production Culture – A Case Study Jim McColgan, Associate Director, Pilot Lab and Production Operations, Pfizer Global Manufacturing 2:45 Networking Refreshment Break 3:15 Successful Elimination of Parvovirus (MVM) Infections of Industrial Scale Cell Cultures – Two Case Studies Tim Hughes, Director, Processes & GMP Facilities, CSL Ltd., Australia 3:45 Inactivation of Viruses and Mycoplasma by Several Barrier Methods Houman Dehghani, Ph.D. Principal Scientist, Biosafety Development Group, Amgen Inc. 4:15 Audience Interactive Panel Discussion 5:00 Close of Symposium Managing Manufacturing Networks Symposium #2: How Much Data is Enough The Statistical Approach to Process Validation 1:00 Chairpersons’ Remarks Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; Former Senior Staff Fellow, OPS, CDER, US FDA 1:05 Statistical Assurance of Process Knowledge and Control: The Means to a Validated Process Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; Former Senior Staff Fellow, OPS, CDER, US FDA 1:50 Elements of a Quality by Design Approach for Biopharmaceutical Drug Substance Bioprocesses Nathan McKnight, Ph.D., Senior Engineer, Late Stage Cell Culture, Genentech, Inc. 2:35 Networking Refreshment Break 3:00 New, Unpublished Data CASE STUDY Process Understanding: How do We Demonstrate that We Know What We Know Carl A. Anderson, Ph.D., Associate Professor of Pharmaceutical Sciences, Duquesne University 3:45 Strategies for Multi-Variate Studies of Critical Process Parameters Ronald D. Snee, Ph.D., Founder and President, Snee Associates 4:30 Audience Interactive Panel Discussion 5:00 Close of Symposium Tuesday, September 21, 2010 • Main Conference 7:00 Registration and Coffee Product Lifecycle Management Symposium #3: Technology Transfer for Biopharmaceuticals 1:00 Chairperson’s Remarks Jean Bender, Ph.D., Principal Engineer, Genentech, Inc. 1:15 Technology Transfer from Development to Manufacturing John Knighton, MBA, Director, Pharmaceutical Development & Manufacturing Sciences, Johnson & Johnson Pharmaceutical Research & Development 1:45 Technology Transfer and Scale-up of an Antibody Process Magnus Glad, Ph.D., Senior Project Manager, Biopharmacy & Protein Technology, BioInvent International, Sweden 2:15 Technology Transfers: Internal versus External, Domestic versus International Younok Dumortier Shin, Ph.D., Technical Lead, Manufacturing Technology, Bristol-Myers Squibb 2:45 Networking Refreshment Break 3:15 Applying Principles of Operational Excellence in Managing Technology Transfer Projects Greg Zarick, M.S., PMP, Associate Director of Project Management, Lonza Biologics, Inc. Michael J. Gorman, M.S., Certified Lean Six Sigma Black Belt and Project Manager, Operational Excellence, Lonza Biologics, Inc. 3:45 Integration of Quality Risk Management into Technology Transfer Lori Richter, Quality Risk Management Associate, Global Quality Risk Management, Genentech, Inc. 4:15 Audience Interactive Panel Discussion 5:00 Close of Symposium Advancements and Case Studies of Hydroxyapatite for Biomanufacturing Leveraging our Assets – How Do We Reconcile the Installed Base with Current Technologies and Demand 7:55 Chairperson’s Remarks Shishir Gadam, Ph.D., Director, Manufacturing Science and Technology, Genentech, Inc. Keynote Presentation 8:05 Optimizing Manufacturing Network Performance and Planning for the Future Biologics manufacturing network performance can be measured across many dimensions including cost, compliance, cycle time etc. It has been useful to consider both plant and network parameters to optimize current state performance. These parameters in addition to considerations of likely business, technology and socioeconomic changes help shape our thoughts for future biologics manufacturing. Alison Moore, Ph.D., Vice President, Corporate Manufacturing, Amgen 8:45 New, Unpublished Data CASE STUDY Manufacturing Aspects of a New Facility: Lessons Learned Shakedown, qualification, and start-up of new biotech manufacturing facilities is a challenging undertaking. Balancing cost, schedule and resources is always a challenge. This talk will review the lessons learned from the design, commissioning, qualification, shakedown, and validation of numerous large scale biotech manufacturing facilities, including process equipment and automation lessons learned. Jeff Johnson, Engineering Director, BioVaccine Process Engineering, Global Engineering Services, Merck & Co., Inc. 9:15 Building the First Patient Specific Product Manufacturing Plants: Design and Construction of Dendreon Corporation’s Innovative Manufacturing Facilities Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for program updates. Ken Hammer, Vice President, Facilities and Engineering, Dendreon Corporation 9:45 Networking Refreshment Break 10:15 New, Unpublished Data CASE STUDY Enabling High Throughput Production in an Existing Commercial Plant Lowering cost of goods is achievable by producing product at higher run rates in an existing facility. This case study presentation focuses on evaluation of historical performance to identify and implement equipment and operational modifications to enable manufacture of product at high run rates. The presentation will report on actual performance after modifications were implemented. Implications for design of future processes will also be discussed. Carol D. Basey, Senior Manufacturing Technical Specialist, Genentech, Inc. Process Design: Establishing Design Space and Robust Process Parameters 8:00 Chairperson’s Remarks Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. 8:15 CASE STUDY Developing an Appropriate Design Space Strategy to Mitigate Variability in Downstream Processing Operations Lot to lot variability in chromatography adsorbent properties can result in unacceptable performance. The column operating conditions may need to be designed to be adsorbent lot specific to achieve acceptable performance. In this presentation, we discuss how a design space strategy can be used to mitigate such risks, by providing additional flexibility in applying the appropriate column operating conditions. Several case studies will be presented. Justin McCue, Ph.D., Principal Engineer, Downstream Process Development, Biogen Idec 8:45 Multivariate Data Analyses and Real-time Multivariate Process Monitoring of Upstream Operations in Biopharmaceutical Manufacturing Biopharmaceutical processes generate large amount of data in commercial operations that require advanced modeling and monitoring. Multivariate technology allows quickly identifying patterns in the process data to help facilitate process learning and troubleshooting. Examples from large-scale manufacturing applications in cell culture process monitoring approaches by using real-time process supervision will be demonstrated. Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc 9:15 CASE STUDY Creating a QbD Chromatography Design Space Using Mechanistic Modeling Techniques The FDA has called QbD “a good scientific approach” which involves “using good science” which “will result in cost benefits for the industry”. This case study applies mechanistic modeling to identify critical parameters and define an ICH/FDA Q8 compliant QbD design space. Simulations were used to improve the separation, reduce operating costs and troubleshoot separation anomalies. Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc. 9:45 Networking Refreshment Break 10:15 New, Unpublished Data CASE STUDY Use of DOE to Determine Process Parameters for a Robust Design Space in the Formulation of a Biopharmaceutical Product Design of experiments (DOE) tools in product and process development can be confusing and frustrating, resulting in missed opportunities for increased knowledge about the product or process under consideration. This presentation will outline general DOE concepts for factorial and fractional factorial DOE’s and describe a DOE used to optimize the formulation of a biopharmaceutical product. Martin Kane, Associate Director Process Statistics, Department of Biostatistics, Human Genome Sciences, Inc. “This conference is invaluable for the quality of ideas exchanged by the participants.” – David Kolwyck, Technical Manager, SAFC, a division of Sigma Aldrich Sponsored by: 8:00 am-12:00 pm We are pleased to bring you a half-day technology workshop featuring many of the world's leading authorities to discuss new advancements and applications in separation science using hydroxyapatite and related materials. In this session, we will discuss modern techniques for separation and analysis of immunoglobulins, enzymes, and related biomolecules from micropreparative to industrial scale. Speakers will present case studies and the latest developments using hydroxyapatite in the manufacturing of biopharmaceuticals. A roundtable discussion will conclude this workshop highlighting key biomanufacturing topics and challenges today. Topics & Presenters: Dissociation of Antibody: DNA Complexes by Hydroxyapatite Pete Gagnon, Chief Scientific Officer, Validated Biosystems Packing Ceramic Fluoroapatite at Multiple Process Scales Jaclyn Shaffer, R&D Associate II, MedImmune Methodology for Extension of Ceramic Hydroxyapatite Column Lifetime Mark A. Snyder, Ph.D., Process R&D Applications Manager, Bio-Rad Laboratories Ceramic Hydroxyapatite Usage in Process Manufacturing Norbert Schuelke, Ph.D., Associate Director, Millennium Pharmaceuticals, Inc. Best Practices for Packing Ceramic Hydroxyapatite at Process Scale Kim Brisack, M.S., Staff Scientist, Bio-Rad Laboratories Key industry leaders to present additional case studies Roundtable Discussion • Downstream process of monoclonal antibodies • Scale-up and optimization of hydroxyapatite, handling and qualification testing • Chemical robustness of ceramic hydroxyapatite • Application of hydroxyapatite in vaccine production Visit www.IBCLifeSciences.com/BPI for complete session details 5 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
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