FDA Updates Potency Rules for Cell and Gene Therapies

Replacing guidance from 2011, the FDA's updated framework emphasizes potency assurance throughout cell and gene therapy development and manufacturing

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The FDA’s final guidance, published November 2, replaces its 2011 guidance on potency testing for cell and gene therapies.
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The guidance recommends a science- and risk-based Potency Assurance Strategy spanning raw materials, manufacturing processes, and laboratory testing.
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The framework integrates potency assurance throughout development, production, commercialization, and postapproval monitoring rather than relying primarily on finished-product testing.
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The guidance addresses potency assessment challenges involving short shelf lives, viral vector therapies, and patient-specific treatments.
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The recommendations allow manufacturers to select controls and analytical methods based on product characteristics and risks; they do not establish a new approval pathway.

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