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Strategies to Control Therapeutic Antibody Glycosylation during Bioprocessing: Synthesis and Separation

Edwards, Elizabeth; Livanos, Maria; Krueger, Anja; Dell, Anne; Haslam, Stuart M; Mark Smales, C; Bracewell, Daniel G; (2022) Strategies to Control Therapeutic Antibody Glycosylation during Bioprocessing: Synthesis and Separation. Biotechnology and Bioengineering , 119 (6) pp. 1343-1358. 10.1002/bit.28066. Green open access

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Abstract

Glycosylation can be a critical quality attribute (CQA) in biologic manufacturing. In particular, it has implications on the half-life, immunogenicity and pharmacokinetics of therapeutic monoclonal antibodies (mAbs) and must be closely monitored throughout drug development and manufacturing. To address this, advances have been made primarily in upstream processing, including mammalian cell line engineering to yield more predictably glycosylated mAbs, and the addition of media supplements during fermentation to manipulate the metabolic pathways involved in glycosylation. A more robust approach would be a conjoined upstream-downstream processing strategy. This could include implementing novel downstream technologies, such as the use of Fc gamma-based affinity ligands for the separation of mAb glycovariants. This review highlights the importance of controlling therapeutic antibody glycosylation patterns, the challenges faced in terms of glycosylation during mAb biosimilar development, current efforts both upstream and downstream to control glycosylation and their limitations, and the need for research in the downstream space in order to establish holistic and consistent manufacturing processes for the production of antibody therapies. This article is protected by copyright. All rights reserved.

Type: Article
Title: Strategies to Control Therapeutic Antibody Glycosylation during Bioprocessing: Synthesis and Separation
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/bit.28066
Publisher version: https://doi.org/10.1002/bit.28066
Language: English
Additional information: © 2022 The Authors. Biotechnology and Bioengineering published by Wiley Periodicals LLC. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/).
Keywords: CQAs, N-glycosylation, antibodies, biosimilars, downstream glycosylation bioprocessing, mAbs
UCL classification: UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10144206
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