Developing an Appropriate Potency Assay to Support Comparability & Aid in Regulatory Approvals

Time: 1:00 pm
day: Regulatory Workshop Day


Utilizing appropriate potency assays are of utmost importance when attempting to prove comparability to regulators, so the design of these assays should be of consideration when undergoing or planning for comparability studies. This session will delve into the development of these potency studies from the perspective of regulators. Key learnings from this workshop:

• Understanding the importance of correct potency assay design

• How to implement these potency assays into your own comparability studies

• Discussing what regulators require from potency assays in approval applications