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FDA finalises potency assurance guidance for cellular and gene therapy products, replacing 2011 document

🇺🇸 FDA CBER · Mon 02 Nov 2026

CBER's final guidance sets out a science- and risk-based approach to potency assurance for CGT products and supersedes the January 2011 potency tests guidance.

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has issued final guidance for industry on potency assurance for human cellular and gene therapy (CGT) products. The document, published under docket number FDA-2023-D-4299, comes from CBER's Office of Therapeutic Products.

The guidance sets out recommendations for building a science- and risk-based potency assurance strategy. FDA describes this as a multifaceted and flexible approach that reduces risks to potency through manufacturing process design, process control, material control, in-process testing and potency lot release assays. The stated goal is that every released lot has the specific ability or capacity to achieve the intended therapeutic effect.

It replaces the 2011 document "Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products". Beyond recommendations on potency assays, the new text describes a broader approach to potency assurance grounded in quality risk management, which can be integrated into a developer's wider control strategy. The source text is truncated at that point, so further detail on integration is not available here.

CBER's Office of Therapeutic Products will host a virtual public webinar on Thursday, 10 December at 1:00 p.m. to highlight key considerations in the final guidance. Comments on any FDA guidance can be submitted at any time, online or by post to the Dockets Management office, quoting the docket number. Questions can be sent to CBER's industry contact point at industry.biologics@fda.hhs.gov.

What it means for your team

  • CMC and QA teams developing CGT products should review their potency strategies against the final guidance, as it replaces the 2011 potency tests document.
  • The guidance frames potency as more than a release assay, spanning process design, process and material controls, and in-process testing, under a quality risk management approach.
  • Regulatory affairs teams may wish to register for the 10 December CBER webinar and note that comments can be submitted to docket FDA-2023-D-4299 at any time.

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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