BIO Suggestions for CGT Potency Guidance
The Biotechnology Innovation Organization (BIO) says an FDA 2023 draft guidance on potency assurance for cellular and gene therapy (CGT) products “addresses a wide range of CGT product development considerations related to potency assurance. The scope helpfully includes both investigational and licensed products, and the different phases of development.”
BIO says that since the 2023 draft guidance will supersede the current 2011 guidance when it is finalized, FDA should address the fact that many topics in the 2011 guidance are not discussed in the 2023 draft. It identifies topics it believes should be included.
BIO includes comments on:
- clarification on alignment with International Council on Harmonization Q9 (R1) and Q10;
- requirements for potency strategy plan; and
- initial potency-related CQAs (critical quality attributes).
It also gives line-by-line specific feedback.