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Potency Tests for Cellular andGene Therapy Products

Updated: Feb 19


We are thrilled to share the latest update from the FDA, aimed at advancing the field of Cellular and Gene Therapy (CGT). The FDA has just released comprehensive guidance for manufacturers of CGT products, offering key recommendations for the development of potency measurement tests.  Why is this Guidance Important?  Potency measurements play a pivotal role in supporting Investigational New Drug Applications (IND) and Biologics License Applications (BLA). The FDA's guidance is tailored to provide clarity on potency information, ensuring a robust framework for regulatory submissions.

Breaking Ground in Cellular and Gene Therapy: FDA Issues Crucial Guidance on Potency Measurement

We are thrilled to share the latest update from the FDA, aimed at advancing the field of Cellular and Gene Therapy (CGT). The FDA has just released comprehensive guidance for manufacturers of CGT products, offering key recommendations for the development of potency measurement tests.


Why is this Guidance Important?


Potency measurements play a pivotal role in supporting Investigational New Drug Applications (IND) and Biologics License Applications (BLA). The FDA's guidance is tailored to provide clarity on potency information, ensuring a robust framework for regulatory submissions.


Key Highlights of the Guidance:

  • The guidance is specifically designed for CGT products reviewed by the FDA's Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), under section 351 of the Public Health Service Act.

  • It supplements existing documents, without replacing or superseding any current guidance, finalizing the draft guidance from October 2008.

  • Importantly, the guidance does not apply to products regulated under section 361 of the PHS Act, products under 21 CFR 1271.10, or those regulated as medical devices under 21 CFR Part 820. It also excludes biological products reviewed by CDER or by CBER’s Office of Vaccine Research and Review (OVRR) or CBER’s Office of Blood Research and Review (OBRR).


Implications for Industry


Manufacturers of CGT products now have a roadmap for developing potency tests that align with FDA expectations. While the guidance doesn't prescribe specific types of assays or acceptance criteria for product release, it provides invaluable insights into the FDA's perspective on potency measurement.


What's Next?


As the field of CGT continues to evolve, staying abreast of regulatory guidance is paramount. This update serves as a catalyst for innovation, fostering a collaborative environment between industry stakeholders and regulatory bodies.


To delve deeper into the FDA's latest guidance, manufacturers are encouraged to review the complete document available on the FDA website.


Contact BioBoston Consulting today or visit our website to learn more about how we can support your organization.



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