Program Information - IBC Life Sciences

More documents

Recommendations

Info

Thursday, September 23, 2010 7:00 Coffee 7:15 Technology Workshop (Light Continental Breakfast Will Be Served) (Rotunda) Are Your ANIMAL FREE Raw Materials Really Animal Free This workshop discusses the approach BD Biosciences-Advanced Bioprocessing is taking to address this question. Michael J. Titus, Ph.D., Director, Quality Management & Regulatory Compliance, BD Biosciences -Advanced Processing Recovery & Purification Cell Culture & Upstream Processing Emerging Analytical Requirements (Room 551) Plenary Session – Integration of Upstream and Downstream Processing (Room Ballroom B/C) 8:00 Chairperson’s Opening Remarks Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corporation 8:15 Challenges and Efficiencies Gained by Integrating Upstream and Downstream Drug Substance PD Gene Schaefer, Ph.D., Senior Director, API-Large Molecule Development, Johnson & Johnson 8:45 Optimizing Interfaces and Hand-offs between Upstream and Downstream Processing Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head, Isolation & Purification Department, Global Biological Development, Bayer HealthCare 9:15 Linking Upstream and Downstream Jonathan Coffman, Ph.D., Principal Engineer III, Pfizer Biotherapeutics 9:45 Networking Refreshment Break in Exhibit and Poster Hall Recovery & Purification (Ballroom B/C) Breakthroughs to De-Bottleneck Downstream Processing Chairperson: Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head, Isolation & Purification Department, Global Biological Development, Bayer HealthCare 10:30 Evaluation of Single Pass TFF to Debottleneck Downstream Processing of Monoclonal Antibodies Jemelle Dizon-Maspat, Senior Research Associate, Genentech, Inc. 11:00 Downstream Breakthroughs in Downstream Processing of High Titer and Cell Density Harvests Blanca Lain, Senior Scientist, Downstream Process Development, Percivia, LLC 11:30 Process Design and Facility Fit Optimization Models for Higher Titer Purification of Monoclonal Antibodies Nuno Fontes, Ph.D., Senior Engineer, Group Leader, Genentech, Inc. Cell Culture & Upstream Processing (Ballroom D/E) Accelerating & Optimizing Cell Culture & Process Development Chairperson: Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme Corporation 10:30 CASE STUDY Rapid Generation of High-Producing Clonal Cell Lines for Recombinant Monoclonal Antibody Manufacture Jolanda Gerritsen, Technical Expert, Cell Line Development, Genmab, The Netherlands 11:00 Scale Down Approaches to Facilitate CHO Clone Development for High- Level mAb Expression Gareth Lewis, Ph.D., Scientist II, MedImmune, United Kingdom 11:30 Boosting Yield, Speeding Up Process Development and Improving Quality by Process Intensification in Mammalian Cell Culture Rolf Douwenga, Vice President, Global R&D, DSM Biologics, The Netherlands Emerging Analytical Requirements and their Impact on Process Development and Manufacturing 8:00 Chairperson’s Remarks Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, Human Genome Sciences Inc. 8:15 FDA Expectations Regarding Bioburden Control in Biotech Processes Patricia F. Hughes, Ph.D., Biotech Manufacturing Team, Office of Compliance, CDER, U.S. Food and Drug Administration 8:45 New, Unpublished Data CASE STUDY Methods for Analysis of Subvisible Particles and the Utility in Biopharmaceutical Process Evaluations Tristan Marshall, Research Associate III, Human Genome Sciences 9:15 Acidic Variants of Antibodies: Characteristics and PK Properties Paul Motchnik, Ph.D., Associate Director, Protein Analytical Chemistry, Genentech, Inc. 9:45 Networking Refreshment Break in Exhibit and Poster Hall 10:30 Analytical Strategies for Monitoring Impurities Encountered in Bioprocessing Jon S. Kauffman, Ph.D., Director, Method Development & Validation and Biopharmaceutical Services, Lancaster Laboratories 11:00 The Potency Assay -- Still Relevant after All These Years Sally Seaver, Ph.D., President, Seaver Associates, LLC 11:30 Audience Interactive Panel Discussion with All Session Presenters Site Tour to Amgen’s BioNext Facility Please arrive for the site tour at 3:45pm at the Sabin Street entrance on the Lobby level. Bus will depart promptly at 4:00pm. You will return to the Rhode Island Convention Center at 6:30pm. Pre-registration is required. Thursday, September 23 • 4:00 pm – 6:30 pm Amgen’s manufacturing plant in West Greenwich, RI, is a four-story, 364,000-square-foot building that contains state-of-the-art manufacturing, production, warehousing, utilities, and office space areas. Built in 2004 to provide manufacturing capacity for Enbrel®, the plant operates 24 hours a day, seven days a week. The plant provides a controlled environment for the manufacture of bulk drug substance. Tour participants will walk through the plant and view through windows some of the production suites, including upstream and downstream manufacturing areas, and will hear from Amgen staff about processes in these areas. Closed-toed shoes must be worn; no high heels are allowed. Check in at attendee registration desk by Wednesday at 2:00 pm if you are pre-registered or would like to attend. 14 www.IBCLifeSciences.com/BPI
Thursday, September 23, 2010 7:00 Coffee Strategy Discussion Forums (Rotunda) Sponsored by 10:30 Smart Flexibility: What Creates the Right Degree of Flexibility and Cost Reduction in Different Phases of Manufacturing Moderator: Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden Panelists: Carol D. Basey, Senior Manufacturing Technical Specialist, Genentech, Inc. Chris M. Brodeur, Senior Manager, Operations, Commercial Expansion Head, BioMarin Pharmaceutical Inc. Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. Robert J. Steininger II, Senior Vice President, Manufacturing, Acceleron Pharma 12:00 Technology Workshops (See next page) 12:30 Networking Luncheon in Exhibit and Poster Hall 1:45 Development and Manufacturing Strategies for Biosimilars Products Moderator: Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc. Panelists: Parrish M. Galliher, Founder and Chief Technology Officer, Xcellerex, Inc. John Kim, Director, Analytical Development, Celltrion, Inc., Korea Friedrich Nachtmann, Ph.D., Head, Biotech Cooperations, Sandoz Biopharmaceuticals, Austria Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc. Formulation Strategies for Protein Therapeutics (Room 555A/556) 8:25 Chairperson’s Remarks Pooja Arora, Ph.D., Research Investigator II, Bristol-Myers Squibb Formulation Strategies for Vaccines 8:30 CASE STUDY Impact of Recombinant Albumin on the Stability of a Malarial Antigen Vaccine Phuong Tran, Ph.D., Senior Scientist, Research and Development, Novozymes, Australia 9:00 CASE STUDY Examining and Correlating the Long Term and Accelerated Stability of a Pneumococcal Antigen Vaccine Manvi Hasija, Ph.D., Sanofi-Pasteur, Canada 9:30 CASE STUDY Formulation and Process Considerations for Stabilization of Live Attenuated Typhoid Vaccine Satoshi Ohtake, Ph.D., Senior Scientist and Senior Manager, Aridis Pharmaceuticals 10:00 Networking Refreshment Break in Meeting Room Formulation Impacts of Device and Packaging Systems 10:30 Characterization, Modelization and Control of Primary Packaging Surfaces to Minimize Non-Native Aggregation of Therapeutic Proteins Thomas Ballet, R&D Engineer, Advanced Technology, Becton Dickinson Medical Pharmaceutical Systems 11:00 CASE STUDY Product Quality and Formulation Considerations in the Development of a Delivery System and Product Packaging Joe Fire, Senior Device and Packaging Engineer, Human Genome Sciences, Inc. 11:30 CASE STUDY The Influence of Formulation on Delivery System Design, and Vice-Versa Douglas Nesta, Ph.D., Director, Biopharmaceutical Technologies, Biopharm R&D Unit, GlaxoSmithKline 12:00 Networking Luncheon, Last Chance for Exhibit and Poster Viewing 1:25 Chairperson’s Remarks Shan Jiang, Ph.D., Director, Formulations, Seattle Genetics, Inc. Formulation Development for Next Generation Biologics 1:30 CASE STUDY Formulation Development for Antibody-Drug Conjugate (ADC) Brentuximab Vedotin (SGN-35) Shan Jiang, Ph.D., Director, Formulations, Seattle Genetics, Inc. 2:00 CASE STUDY Development and Implementation of a Thermal Melting Assay for High-Throughput Screening of Liquid Adenoviral Formulations Janik Adriaansen, Ph.D., Scientist, Crucell, The Netherlands 2:30 CASE STUDY Formulation Development for Subcutaneous Delivery of Plasma Derived Proteins Sylvain Huille, Ph.D., Head of Department, Biopharmaceutical Development, LFB Biotechnologies, France 3:00 Conference Ends Audience Interactive Panel Discussion: Point/Counterpoint (Exhibit and Poster Hall) 2:30 BPSA Quality Agreement Templates for Single-Use Products used under Drug cGMP Presenters: BPSA Representative: David Radspinner, Ph.D., Global Director of Marketing and Product Management, Thermo Fisher Scientific Industry End-User Representative: Wolfgang Noe, Ph.D., Vice President, Strategic Development & Technical Alliances, Biogen Idec March 14 - 18, 2011 Hyatt Regency Bellevue Bellevue, WA Register Early & Save $400 n Antibody Development & Production n Process & Product Validation n Technology Transfer for Biopharmaceuticals n Outsourcing Manufacturing of Biopharmaceuticals n Recombinant Protein & Complex Biologic Development & Production n Analytical Technologies for Biotherapeutic Development Save Up to $400 if you register online by November 19, 2010 with Priority Code BDPWG www.IBCLifeSciences.com/bdpweek Discounts are off standard rates, valid for new registrations only & cannot be combined with any other offer. BioProcess International Conference & Exhibition 15
Page 1: Program Information Conference: Sep
Page 4 and 5: Agenda Overview (Includes Room Assi
Page 6 and 7: Platinum Sponsors: Aisle Sign Spons
Page 8 and 9: Tuesday, September 21, 2010 7:00 Re
Page 10 and 11: Tuesday, September 21, 2010 (contin
Page 12 and 13: Managing Manufacturing Networks (Ba
Page 16 and 17: Thursday, September 23, 2010 (conti
Page 18: Recovery & Purification (Ballroom B
Page 21 and 22: Poster Presentations Featured in th
Page 23 and 24: Exhibit Hall Floor Plan - Level 3 P

Program Information - IBC Life Sciences

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?