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W102
Comparability for Cell and Gene Therapy Products
Date
June 10, 2020
This product is not available for individual purchase, but it is available as part of the following products:
The CGTP 2020 Symposium will explore how to continue to adapt concepts applied to other biologics and how to establish novel approaches where they are needed.
Comparability is a significant challenge for advanced therapies due to issues such as complexity of the products, limited amounts of material available for testing, patient-specific variability, and short shelf life. In addition, in many cases early clinical success is driving shortened development timelines that impact the timing of manufacturing changes. This session will focus on some of the challenges and strategies to address comparability for advanced therapies. The session will address both recent regulatory updates related to comparability and sponsor experience addressing comparability.
Speakers
Genentech, a Member of the Roche Group
bluebird bio, Inc.
CBER, FDA
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