W101b - Analytical Bridging: How to Cross on the Wire Stretched Between Two Bioassay Methods? A Case Study

Biological products rely on a wide range of analytical methods for lot release and stability testing. As method improvement is a continued effort during lifecycle management of biopharmaceuticals, bridging studies are key to demonstrate comparability between methods (i.e. early versus late phase bioassays). Through a case study, we will attempt to clear the way, sometimes complex, allowing to establish the link between two potency methods and the key parameters to be considered in a bridging exercise.