Health / Drugs & FDA
FDA finalizes potency guidance for cell and gene therapies
The guidance replaces a 2011 document and asks makers to build potency checks into every development stage.
Status: source-checked.
The Food and Drug Administration issued final guidance Nov. 2 recommending a risk-based plan for checking the potency of cell and gene therapies throughout development and after approval, the agency said.
The guidance replaces a 2011 document on potency testing. It describes how manufacturers can test whether each batch is biologically active in a way that matches its intended therapeutic effect, according to the FDA. It is a statement of the agency’s current thinking and recommendations on meeting existing requirements, not an announcement that a particular therapy has been approved.
The recommendations address variability in raw materials, testing during manufacturing and laboratory checks on the finished product. They cover early investigational applications, licensing applications and continued checks after a product reaches the market, the agency said.
The document also addresses products with short shelf lives, therapies using viral vectors and treatments made for individual patients. Those are among the manufacturing circumstances the FDA identifies as needing specialized consideration.
The FDA said it will hold a webinar Dec. 10 to explain the guidance. This article is based on the agency’s announcement; the full guidance has not been independently analyzed, and the release does not establish how any specific pending application will be affected.
What we know / what we don't
What we know
- The final guidance replaces FDA's 2011 potency testing guidance for these products.
What we don't know
- How the guidance will change specific pending applications is not stated.
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