Redefining biologics safety through advanced analytics: MS-based host cell protein profiling

Trends in biotechnology 2026 Open access

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Authors: Paresh Tank, Fatima D'Souza, Nagarajan Kayalvizhi, Neelamegam Rameshkumar
DOI: 10.1016/j.tibtech.2026.05.011
Cited by: 1
References: 9

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.

Fields of Study & Subjects

Advanced Proteomics Techniques and Applications Advanced Biosensing Techniques and Applications vaccines and immunoinformatics approaches

Publication details

Journal / source
Trends in biotechnology
Publisher
Elsevier BV
Publication date
1 June 2026
Language
EN