Getting Down to Bioassay Brass Tacks

PANEL DISCUSSION: Getting Down to Bioassay Brass Tacks
DATE:October 18, 2024
LOCATION:Washington, DC

The lifecycle approach and use of tools to enable quality-by-design are now an underpinning of the FDA’s expectations for achieving potency assurance. To quantify potency-related CQAs, bioassay development must take into consideration (1) current regulatory requirements and guidance, (2) the nature of the product, and (3) the statistical tools needed to evaluate decisions. That said, uncertainty about how regulatory authorities determine the suitability of potency assays still persists. This session is intended to stimulate dialogue about the challenges faced by stakeholders in the development of bioassays to support CGT products and to increase clarity about current regulatory thinking