Best Practices In Host Cell Protein Assay Qualification And Bridging To A New Assay

Explore a case study using a specific HCP immunoassay and advanced orthogonal Antibody Affinity Extraction (AAE™) and Mass Spectrometry (MS) methods for assay qualification. Data showing HCP identification by MS in product harvest, in–process samples and final drug substance is reviewed. Cygnus Technology's Vice President of Research and Development, Eric Bishop, discusses the integration of MS proteomics methods with ELISA and AAE for a comprehensive characterization of HCP impurities, and how these data-driven approach aids in objective determination whether a process–specific assay is necessary and superior to a well–developed generic or platform method.