Challenges Meeting the CMC and Clinical Material Requirements During Gene Therapy Development

Posted on August 17, 2022

Clare Blue Ph.D., Director, Biologics / Gene Therapy Development, TDPL
Linda Engle Ph.D., Principal Scientist/Associate Director, Analytical Development, CMC Lead, Gene Therapy Portfolio
Kruti Soni Ph.D., Scientist II, Technical Development
Biogen, Inc.

Problem Statement The therapeutic potential of gene therapy-based products for treating a wide range of life-threatening / disabling diseases is becoming well-established, with several gene therapies already approved and many more being evaluated in clinical trials. Sponsor companies have dedicated ...

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