BEBPA US Bioassay 2024

DATE:March 10-12, 2024

My talk at BEBPA US Bioassay 2024 is on Tuesday March 12: Using Equivalence Testing to Define Lot Release Limits for Product Potency

Potency is a critical quality attribute for all biologics. The impact of process variability on potency levels can include changes in the safety or efficacy of the product. The ability to discriminate potency levels across product lots is dependent on the chosen release limits and the measurement uncertainty associated with the reported value. Because potency is typically a relative measure with 100% being an assigned target, the goal of QC testing early on is to confirm equivalence of individual batches to the intended target.

This strategy supports the expectation that minimum effective dose and maximum tolerated dose estimates are derived from pre-clinical and clinical studies using product batches with relatively consistent potency. At licensure, the manufacturing process and the test method must be operating in a state of control such that batches will routinely be similar enough to the 100% target to be considered safe and effective. This can be accomplished by establishing a specification using a formal statistical hypothesis framework and reducing analytical error during the development process.

This presentation will cover the rationale for choosing an equivalence-based approach over a difference test and will include an example analysis.