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
Senior Scientist, Chromatography and Mass Spectrometry
Alla Zilberman, PhD
Vice President, Strategic Marketing and Business Development
HCP Immunoassay Qualification: Review of Orthogonal Methods
A broadly reactive HCP ELISA is critical for monitoring purification process consistency and final drug substance purity. HCP ELISA used by a sponsor must be qualified to prove it’s fit for purpose. Here we present an overview of assay qualification steps and demonstrate how the orthogonal Antibody Affinity Extraction and Mass Spectrometry methods assess coverage of ELISA Ab to HCPs present in a given process and identify process-specific HCPs that may co-purify with a drug substance.
