Relative potency assays are critical in evaluating the biological activity of drug products throughout the lifecycle of biopharmaceuticals. Managing variability, optimizing assay conditions, and ensuring consistent performance are essential but challenging.

This presentation explores how JMP supports developing, validating, and monitoring relative potency assays in CMC (chemistry, manufacturing, and controls).

By integrating data visualization, statistical analysis, and modeling tools (such as logistic regressio and response surface methodology for establishing optimal assay conditions), and mixed-effects models (for estimating intermediate precision and relevant replication strategies), JMP enables robust assay development, validation, and ongoing performance monitoring. The automation and scripting capabilities within JMP further streamline repetitive data analysis, facilitating method/operator performance assessments and ongoing procedure performance verification (OPPV) of bioassays in a regulated environment.