December 1, 2011
Antibody Development and Production covers the entire spectrum of topics related to development and production of the most promising therapeutics in the biopharmaceutical industry. An estimated 30% of new drug products likely to be licensed in the next decade will be antibodies. With the reality of their biosimilar equivalents getting closer, companies need to develop processes faster to preserve their time on the market free from generic competition and keep costs down. With that in mind, we developed the 2012 agenda to help you improve process development through innovation, integration, and optimization; improve product quality in process development; and develop and implement downstream approaches that capitalize on high-titer processes.
New This Year
For 2012, we expanded our coverage to include more diverse antibody-related products. Companies of all sizes will provide multiple perspectives on strategies and approaches that help overcome current and future bioprocessing challenges. For example, where is innovation needed in process development — and how much? How does antibody engineering influence development and production? Presentations will address virus risk mitigation; developing and delivering high-concentration formulations; characterization and comparability; and development and production of novel antibody formats, novel molecules, and next-generation antibodies.
Sessions
Next Wave of Process Development: Improvements through Innovation, Integration and Optimization
Implementation of Novel, Cost-Effective Approaches to Capitalize on High-Titer Processes
Improving the Interface Between Upstream and Downstream Processing
Impact of Antibody Engineering on Development and Production
Advances in Cell Line Selection, Development, and Engineering
Advances and Alternatives to Improve Harvest and Capture
Overcoming Challenges of Developing and Delivering High-Concentration Formulations
Improving Product Quality in Process Development
New Approaches and Strategies for Characterization and Comparability
Development and Production of Drug Conjugates
Development and Production of Next-Generation and Novel Molecules
Keynotes and Featured Presentations
“The CHO Cell Factory: Engineering the Shift from Screening to Design,” by David C. James (Department of Chemical and Process Engineering, University of Sheffield, UK)
“MMV Contamination: A Case Study and Lessons for the Industry,” by Mark D. Moody (Merrimack Pharmaceuticals)
“Is Innovation Dead in a Platform World?” by Thomas Spitznagel (Human Genome Sciences)
“Comparability and Biosimilarity: Two Sides of the Same (or a Different) Coin?” by Drew N. Kelner (Amgen Inc.)
“What does the Future Hold? Analytical Tools for Biopharmaceutical Development,” by Rohin Mhatre (Biogen Idec)
Featured Presenters Address Critical Topics: Anthony S. Lubiniecki (Johnson & Johnson Pharmaceutical R&D, Inc.) addresses how single-product comparability differs from biosimilarity between two products. Morris Rosenberg (Seattle Genetics) describes the path to regulatory approval for antibody–drug conjugates. Weichang Zhou (Genzyme, a Sanofi Company) discusses continuous bioprocessing for production of biopharmaceuticals. Dayue Chen (Eli Lilly and Company) applies a quality by design approach to viral clearance studies. And Steven J. Shire (Genentech, Inc.) presents formulations for subcutaneous delivery of high-dose monoclonal antibody formulations.
Colocated Conferences
This conference is part of IBC’s
Biopharmaceutical Development and Production Week. Attendees can get the most out of their travel budget with an “All-Access Pass” to attend sessions from all nine conferences.
Arrive Early and Attend the First Half of the Week: 27–28 February 2012 conferences include Process and Product Validation; Technology Transfer for Biopharmaceuticals; Outsourcing Manufacturing of Biopharmaceuticals; Biopharmaceutical Raw Materials throughout Product Lifecycle; and Viral Safety for Biologicals. Attend sessions from these colocated conferences at no additional cost.
Concurrent conferences include Recombinant Protein and Complex Biologic Development Production; Analytical Technologies for Biotherapeutic Development; and Biobetters and Biosimilars: Technologies and Development Strategies. Find more details and full conference agenda for all nine conferences online at www.IBCLifeSciences.com/BDPWeek.
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