Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop
The FDA Law Blog
NOVEMBER 1, 2022
The workshop included presentations by USP on its available standards for advanced therapies, FDA/CBER on CMC challenges for CART cell therapies, and industry approaches to potency testing during CART development, and using Analytical Quality by Design (AQbD) principles in potency assay development. Release testing alone is not sufficient.
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