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GUIDANCE DOCUMENT

Potency Assurance for Cellular and Gene Therapy Products December 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-4299
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

On December 28, 2023, FDA announced the availability of the draft guidance, Potency Assurance for Cellular and Gene Therapy Products. For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Matthew Klinker, Cell Therapy Branch 2 Chief, Office of Cellular Therapy and Human Tissues, Office of Therapeutic Products, CBER.

This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency  of a human cellular therapy  or gene therapy  (CGT) product.  A potency assurance strategy is a multifaceted approach that reduces risks  to the potency of a product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays.   The goal of a potency assurance strategy is to ensure that every lot of a product released will have the specific ability or capacity to achieve the intended therapeutic effect.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-4299.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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