Discover the latest FDA guidance on potency measurements for cellular and gene therapy products. Learn about the implications for manufacturers and the importance of compliance in regulatory submissions.
Pioneer Work in Cell and Gene Therapy: FDA Releases Important Potency Measurement Guidance
The newest FDA advancement for Cellular and Gene Therapy (CGT) space is Guidance for Development Potency Assays. FDA also published a new guidance for potency measurements tests being developed by manufacturers of CGT products.
Why is this Guidance Necessary?
Potency measurements are a critical component of the support necessary for Investigational New Drug Applications (IND) -and Biologics License Applications (BLA). The FDA guidance aims to provide advice for the establishment of potency information that is necessary for a regulatory submissions data package.
Highlights of the Guidance
The recommendations are tailored to cell gene therapy (CGT) products under the jurisdiction of the FDA’s Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER) as described in section 351 of the Public Health Service Act. That finalizes the draft guidance from October 2008 but supplements existing documents, not to replace or supersede any current guidance.
The guidance specifically does not apply to products subject to regulation under section 361 of the PHS Act, products defined in 21 CFR 1271.10 or regulated as a device under part 820 (21 CFR Part 56). It also does not include any biologics regulated by the CDER or to the The Office of Vaccines Research and Review (OVRR) in CBER and the Office of Blood Research and Review (OBRR) at CBER.
Implications for Industry
Now, manufacturers of CGT products have a path forward for the development of potency tests that meet FDA expectations. The guidance does not have specific types of assays or acceptance criteria for product release, however, it provides a valuable perspective on the FDA’s thinking regarding potency measurement.
What’s Next?
The CGT landscape is everchanging, and keeping informed on key regulatory guidance is essential. The update has been the change agent in driving innovation and working together between these native regulated entities, enabling a more collaborative barrier.
Conclusion
Manufacturers are advised to read the full document from FDA on its website for further details on the latest guidance.
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