Fractionated charge variants of biosimilars: a review of separation methods, structural and functional analysis

Yüce, Meral and Sert, Fatma and Torabfam, Milad and Parlar, Ayhan and Gürel, Büşra and Çakır, Nilüfer and Dağlıkoca, Duygu E. and Khan, Mansoor A. and Çapan, Yılmaz (2021) Fractionated charge variants of biosimilars: a review of separation methods, structural and functional analysis. Analytica Chimica Acta, 1152 . ISSN 0003-2670 (Print) 1873-4324 (Online)

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The similarity between originator and biosimilar monoclonal antibody candidates are rigorously assessed based on primary, secondary, tertiary, quaternary structures, and biological functions. Minor differences in such parameters may alter target-binding, potency, efficacy, or half-life of the molecule. The charge heterogeneity analysis is a prerequisite for all biotherapeutics. Monoclonal antibodies are prone to enzymatic or non-enzymatic structural modifications during or after the production processes, leading to the formation of fragments or aggregates, various glycoforms, oxidized, deamidated, and other degraded residues, reduced Fab region binding activity or altered FcR binding activity. Therefore, the charge variant profiles of the monoclonal antibodies must be regularly and thoroughly evaluated. Comparative structural and functional analysis of physically separated or fractioned charged variants of monoclonal antibodies has gained significant attention in the last few years. The fraction-based charge variant analysis has proved very useful for the biosimilar candidates comprising of unexpected charge isoforms. In this report, the key methods for the physical separation of monoclonal antibody charge variants, structural and functional analyses by liquid chromatography-mass spectrometry, and surface plasmon resonance techniques were reviewed.
Item Type: Article
Uncontrolled Keywords: Biosimilars; Charge heterogeneity; Chromatography; Electrophoresis; Mass spectrometry; Surface plasmon resonance
Divisions: Faculty of Engineering and Natural Sciences > Academic programs > Biological Sciences & Bio Eng.
Faculty of Engineering and Natural Sciences
Sabancı University Nanotechnology Research and Application Center
Depositing User: Meral Yüce
Date Deposited: 19 Aug 2022 09:34
Last Modified: 19 Aug 2022 09:34

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