Octet potency assay: Development, qualification, and validation strategies

The determination of drug analyte characteristics can be affected by the test method used. In this application note, Sartorius discusses the strategies for the development and validation of a potency assay using Octet^® systems. We have highlighted the Octet^® system’s ease-of-use and fast time to results by showcasing strategies for the development and validation of a method for evaluating the binding of an Fc gamma receptor III molecules to the widely characterized NISTmAb.