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Updated: Jun 4, 2026
Host Cell Protein Analysis using Enrichment Beads Coupled with Limited Digestion
Published on: January 19, 2024
Redefining biologics safety through advanced analytics: MS-based host cell protein profiling
Paresh Tank1, Fatima D'Souza2, Nagarajan Kayalvizhi3
1Amity Institute of Biotechnology, Amity University, Mumbai, Pune Expressway, Bhatan, Post-Somathne, Panvel, Mumbai, Maharashtra 410 206, India; Analytical Chemistry Division of Zelle Biotechnology Research and Analytical Services, Zelle Biotechnology Pvt. Ltd., A-7 M.I.D.C., Mira Industrial Area, Western Express Highway, Mira Road, Thane, Maharashtra 401 104, India.
Abstract:
Recent regulatory and pharmacopeial guidance highlights attention to host cell protein (HCP) impurities in biologics. Advances in liquid chromatography-mass spectrometry (LC-MS) enable molecular-level characterization of HCPs beyond immunoassay measurements. This article examines how LC-MS-based HCP profiling strengthens impurity risk assessment, improves process understanding, and supports analytical strategies for biologics quality and safety.
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