Navigating early cell and gene therapy development: CMC perspectives

Chemistry, Manufacturing and Controls (CMC) is critically important to the regulatory success of any cell and gene therapy product (CGT) – yet due to common challenges, many companies fail to get it right the first time. This article will highlight some of the key CMC issues that need to be managed during development and regulatory submission.

The CMC section of a regulatory submission encompasses a summary of the manufacturing process, in-process controls, product quality assays, specifications, and stability studies for both drug substance and drug product. The CMC section is one component, along with the nonclinical and clinical sections, that comprise an IND or a BLA.

Why CMC is important for cell and gene therapy development?

CMC challenges and mitigation strategies


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