5 Key Takeaways

• 1

  The FDA’s final guidance, published November 2, replaces its 2011 guidance on potency testing for cell and gene therapies.

• 2

  The guidance recommends a science- and risk-based Potency Assurance Strategy spanning raw materials, manufacturing processes, and laboratory testing.

• 3

  The framework integrates potency assurance throughout development, production, commercialization, and postapproval monitoring rather than relying primarily on finished-product testing.

• 4

  The guidance addresses potency assessment challenges involving short shelf lives, viral vector therapies, and patient-specific treatments.

• 5

  The recommendations allow manufacturers to select controls and analytical methods based on product characteristics and risks; they do not establish a new approval pathway.