I will be co-chairing the BIOASSAY — FROM FRAMEWORK TO FAQs session as part of the “Optimizing Bioassays for Biologics” track on October 5, 2023.

I will also be presenting in the same session.

Title: Applying an Equivalence Model to Set Lot Release Specifications for Relative Potency

Abstract: The center of a specification for product potency represents the target value of 100%. Because assays used to measure relative potency yield lognormal
data, statistical analyses must be performed on log transformed values. The center of the lot release specification becomes 0 for log base 10 transformation of relative potency 1.0 (100%). To conclude that a lot is satisfactory, statistical equivalence to 0 should be demonstrated. This requires that the reported value and its confidence interval (e.g., 90%) to fall within established equivalence bounds. Drifts in product potency, assay performance, and statistical error tolerance must be considered in setting bounds