pharmaphorum January 12, 2026
The FDA has said it will reduce the regulatory requirements on the manufacturing of cell and gene therapies (CGTs) in order to make it easier for developers to bring them to market.
Specifically, the US regulator wants to amend its position on the chemistry, manufacturing, and controls (CMC) portion of marketing applications for CGTs, taking a more flexible approach that recognises they are produced very differently from other pharmaceutical products.
CGTs tend to be made in very small batches, often using complex and sophisticated processes that are under time constraints. For example, the manufacture of CAR-T therapies for blood cancers can involve an intricate process of harvesting cells from patients, modifying them and growing them up in culture, and then...
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