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A novel approach to evaluate ELISA antibody coverage of host cell proteins—combining ELISA‐based immunocapture and mass spectrometry

22 Feb 2020

Abstract excerpt

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...

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PMID: 32087048
DOI: 10.1002/btpr.2983

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