Regeneron Pharmaceuticals, Inc.
UNBIASED AND HIGH-THROUGHPUT IDENTIFICATION AND QUANTIFICATION OF HOST CELL PROTEIN IMPURITIES BY AUTOMATED ITERATIVE LC-MS/MS (HCP-AIMS) FOR THERAPEUTIC PROTEIN DEVELOPMENT

Abstract:

The present disclosure generally pertains to methods of identifying and quantitating host cell proteins (HCPs) in therapeutic protein development. In particular, the present invention generally pertains to methods of liquid chromatography-tandem mass spectrometry (LC-MS/MS) for unbiased identification and sensitive quantitation of HCPs in therapeutic protein development.