Host Cell Protein Analysis: Immunoassays

By Alla Zilberman, Kerry Wooding, Jacob Stubbs, Jared Isaac, and Eric Bishop

First seen in BioProcess International Magazine

Immunoassays and orthogonal characterization by antibody affinity extraction and mass spectrometry methods. Host cell proteins (HCPs) are produced inadvertently during the expression of recombinant biopharmaceuticals and secreted from host cells in response to cell stress and/or cell lysis over the course of bioprocessing. Many HCPs are benign, but some are immunogenic.

Learn about the sensitive and specific orthogonal methods necessary to identify individual HCP impurities that persist through DS purification processes. These complementary technologies are an integral part of how biopharmaceutical manufacturers can ensure product purity and consistency. These methods include AAE chromatography with 2D-PAGE or MS for HCP antibody coverage analysis and AAE-MS analysis for identification and quantitation of HCPs from in-process samples and final drug substances.