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Why Gene Therapy Manufacturing Fails FDA
Why do even the most revolutionary gene therapies with promising clinical results face critical roadblocks on their path to commercial approval? In this episode of the DDReg Knowledge Capsule, we delve deep into the core reasons behind Biologics License Application (BLA) delays, focusing on common Chemistry, Manufacturing, and Controls (CMC) pitfalls, weak analytical strategies, and limited comparability data.We unpack the regulatory expectations of the FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Therapeutic Products (OTP), highlighting why early regulatory…
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