With decades of experience and a sucessful industry track record, Cygnus Technologies experts are ready to discuss your HCP analysis inquiries and projects.
Eric Bishop
Vice President of Research and Development
Jared Isaac, PhD
Associate Director, Chromatography and Mass Spectrometry
Alla Zilberman, PhD
Vice President, Strategic Marketing and Business Development
Best Practices in Host Cell Protein Assay Qualification and Bridging to a New Assay
A case study using a specific HCP immunoassay and advanced orthogonal Antibody Affinity Extraction (AAE™) and Mass Spectrometry (MS) methods for assay qualification is presented. Data showing HCP identification by MS in product harvest, in–process samples and final drug substance is reviewed. We also discuss 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.
