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CMC Strategy Forum Summer 2018
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Forum Co-chairs:
Sarah Kennett, Genentech, a Member of the Roche Group
Anthony Mire-Sluis, AstraZeneca

Scientific Organizing Committee:
Siddharth Advant, Celgene Corporation
Cristina Ausin, CDER, FDA
Barry Cherney, Amgen Inc.
Steve Falcone, Sanofi
Alexey Khrenov, CBER, FDA
Mike Tarlov, NIST-National Institute of Standards and Technology

The future of biotechnology manufacturing has to enable the drivers facing the biotechnology industry – the need to decrease cost of goods, market globalization, allow for more rapid development of pipeline products, reduce risk to patient supply, increase product quality etc. The utilization of new technologies such as single use bioreactors, alternating tangential flow during fermentation, modular and closed process equipment, process analytical technology and Analytics of the Future will allow for a more robust process, reduced waste, increased titers, less non-conformances, less staffing required and dramatically less risk to technology transfer to new sites. The ability to utilize single use, pre-sterilized bioreactors and raw materials in a closed process eliminates the need for cleaning and steaming in place and reduces the risk of contaminations. The ability to create a modular, essentially identical, manufacturing sites across the globe means that technology transfer will require much less effort and risk. PAT and analytics of the future should allow for much more real time control of the process and less reliance on lot release assays, as well as driving more testing onto the manufacturing floor and reducing the costly footprint of the Quality Control Laboratories. In addition, advances in molecular modeling and cell cloning, as well as the ability to model processes such as column chromatography should allow for improved titers, less molecular variability and more rapid process development. However, the use of these novel technologies and the design of future biotechnology manufacturing sites will challenge regulatory paradigms; hence the need to partner with regulatory authorities as the future becomes a reality.



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5/14/2018 » 5/16/2018
CMC Strategy Forum Europe 2018

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