THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality
Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 ·
Innovating mAb Production to Support the Immunotherapy Revolution
A new paradigm in cancer therapy is emerging with the recent success of the antibody mediated, immune tumor killing response for melanoma. Evaluations have expanded to include a range of tumor types. In addition new alternatives and combinations are aimed at improving patient non responsiveness to PD-1. These foundational efforts of emerging cancer treatment need to be supported by agile antibody supply solutions that meet the capacity demands, while improving global access and lowering costs. Technology solutions have been implemented to speed process development and shorten the critical time to first in human clinical studies. Innovative approaches towards the 'process of the future' will be shown that support flexible multi product lower cost manufacturing. Continuous processing enabled by single use provides an integrated solution and the implementation challenges will be discussed.
David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc.
Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics
The movement of a large portfolio, consisting of a broad spectrum of biological molecule-modalities, requires seamless integration from the research bench to the clinic. Deep alignment and partnership between the Research and the Process/Analytics functions allows for rapid and systematic product candidate screening, eliminating the most problematic candidates. Combining state-of-the-art cell lines with a regimented application of robust high-throughput process and analytical development packages enables record speeds to the first patient with minimal resources.
Spencer Fisk, Global Head, Biologics Process R&D, Novartis Pharma AG, Switzerland
Novel Approach to Developing and Producing Human Experimental Vaccines for HIV
Michael Anthony (Tony) Moody, M.D., Chief Medical Officer, Associate Professor of Pediatrics, Duke Human
Chairperson's Opening Remarks
John Hallinan, Chief Business Officer, MassBio
Amgen's Next-Generation Biomanufacturing Facility
Described here is the establishment of a biomanufacturing platform for the production of biologic medicines. Competitive product portfolios that can respond quickly to changes in market dynamics have necessitated optimization of production strategies. The "Next-Generation Biomanufacturing" platform allows for fast and flexible drug operations for synthesis of drug substance in a reconfigurable manufacturing system. Key enabling technologies include modular construction, single-use bioreactors, disposable plastic containers, continuous purification processing and real-time quality analysis. Amgen's Next-Generation Biomanufacturing changes the way we will manufacture in the 21st Century.
Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd.
What is the Future of Continuous Processing - What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?
Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme