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M104

Innovative CMC Approaches when Faced with Accelerated Development

Date
June 8, 2020
This product is not available for individual purchase, but it is available as part of the following products:
Thumbnail for Cell & Gene Therapy Products 2020
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.

Innovative regulatory pathways for cell and gene products have accelerated product development and approval allowing patients in need to access transformative therapies. However, the shortened development timeline has exerted significant pressure to accelerated CMC development.

One of the biggest challenges is to develop, characterize, and validate the manufacturing process under these compressed clinical development timelines while ensuring comparability between process versions and maintaining the link to clinical data. In the past few years, several cell and gene therapy products have overcome this challenge and successfully launched new CGTPs. This session will provide the challenges industry is facing and approaches to speed up the CMC development. Perspectives from regulators will help set the expectations of CMC acceleration and pathways to facilitate innovation.

Specifically, the session will demonstrate how risk assessments are leveraged to guide process development activities for these products to ensure that the CGTP can be manufactured commercially and meet the CQAs established during registration trials.

Speakers

Speaker Image for Marcel Hoefnagel
MEB-Medical Evaluations Board
Speaker Image for Darius Pillsbury
ValSource, Inc.
Speaker Image for Anna Kwilas
CBER, FDA

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