The Necessity Of Potency Assay Matrices For Complex Proteins

For complex proteins, the FDA requires a matrix of orthogonal potency assays. Sponsors must assess all functional activities of a product, especially when the mechanism of action is known.

"FDA has pretty much always said was that if your product exhibits multiple functional activities, sponsors need to assess those multiple functional activities," said Diana Colleluori, principal consultant for Biologics Consulting Group. "Whether it's a effector, target, receptor. If you have a bispecific antibody, you're never going to get away from having to assess all the functions of your product, especially when you know what the mechanism of action is."