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FDA finalises potency assurance guidance for cell and gene therapies, replacing 2011 document

🇺🇸 FDA CBER · Mon 02 Nov 2026

CBER's final guidance sets out a risk-based Potency Assurance Strategy for CGT products, covering development through post-market verification and superseding the agency's 2011 potency testing guidance.

The US Food and Drug Administration has issued final guidance on potency assurance for cellular and gene therapy (CGT) products. Titled Potency Assurance for Cellular and Gene Therapy Products, it replaces the agency's 2011 potency testing guidance and applies to treatments for serious and often life-threatening conditions.

The document sets out FDA's recommendations for a Potency Assurance Strategy. This is a science- and risk-based plan under which manufacturers test and verify, before a product reaches a patient, that every batch meets a defined standard of potency, meaning it can do what it is intended to do therapeutically. The agency notes that manufacturers are legally expected to verify that products work as intended from approval through post-approval monitoring.

FDA says the recommendations are flexible and cover potency considerations from early-phase investigational new drug (IND) submissions through biologics license application (BLA) approval and continued post-market verification. Key topics include controls for raw material variability, in-process testing during manufacturing, and laboratory assays confirming that each batch is biologically active in a way that reflects its intended therapeutic effect. The guidance also addresses products with short shelf lives, viral vector gene therapies and patient-specific therapies.

CBER Director Karim Mikhail said patients receiving these therapies, often for cancers and rare diseases, deserve assurance that the product will perform as intended. FDA will hold a webinar on 10 December 2026 to help stakeholders understand and implement the guidance.

What it means for your team

  • Sponsors with CGT products in development or on the market should compare current potency approaches with the new guidance, which replaces the 2011 document.
  • QA and CMC teams should look at raw material variability controls, in-process testing and biological-activity assays as part of a lifecycle potency strategy.
  • Teams working on viral vector, short shelf-life or patient-specific products should review the sections that address those categories specifically.
  • The 10 December 2026 FDA webinar offers an opportunity to clarify implementation questions.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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