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- Title
Advances in mass spectrometry-based approaches for characterizing monoclonal antibodies: resolving structural complexity and analytical challenges.
- Authors
Mojumdar, Abhik; Yoo, Hee-Jin; Kim, Duck-Hyun; Park, Jiwon; Park, Su-Jin; Jeon, Eunji; Choi, Sunhee; Choi, Jung Hoon; Park, Moonhee; Bang, Geul; Cho, Kun
- Abstract
Mass spectrometry (MS)-based intact mass analysis and structural characterization of biotherapeutic proteins such as monoclonal antibodies (mAbs) are a crucial characterization approach from upstream drug development to downstream product analysis. Due to various endogenous modifications leading to the structural heterogeneity and several N-linked glycan species resulting in macro-heterogeneity, it is challenging to characterize the mAbs. Hence, it is essential to understand the micro-heterogeneity of such proteins with high level of complexity which may vary in charge, size, or hydrophobicity. The development of high-throughput native separation techniques hyphenated with MS with high sensitivity and excellent mass accuracy has improved the top/middle down analysis, intact mass detection, subunit analysis, enhanced sequence coverage, and accurate localization of site-specific modifications. In this review, we have focused on the critical inroads taken for the improvement in MS-based techniques to resolve the challenges related to analysis of mAbs. Various MS-based techniques and their role in high-order structural analysis and the progress in software development have been explained, and further, the challenges remaining have been discussed.
- Subjects
MONOCLONAL antibodies; MASS spectrometry; COMPUTER software development; DRUG development; NEW product development
- Publication
Journal of Analytical Science & Technology, 2024, Vol 15, Issue 1, p1
- ISSN
2093-3134
- Publication type
Article
- DOI
10.1186/s40543-024-00437-1