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Monitoring host cell proteins (HCPs) is one of the most important analytical requirements in production of recombinant biopharmaceuticals to ensure product purity and patient safety. Enzyme‐linked immunosorbent assay (ELISA) is the standard method for monitoring HCP clearance. It is important to validate that the critical reagent of an ELISA, the HCP antibody, covers a broad spectrum of the HCPs potentially present in the purified drug substance. Current coverage methods for assessing HCP antibody coverage are based on 2D‐Western blot or immunoaffinity‐purification combined with 2D gel electrophoresis and have several limitations. In the present study, we present a novel coverage method combining ELISA‐based immunocapture with protein identification by liquid chromatography–tandem mass spectrometry (LC–MS/MS): ELISA‐MS. ELISA‐MS is used to accurately determine HCP coverage of an early …