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Strategies to control therapeutic antibody glycosylation during bioprocessing: Synthesis and separation.

Authors
  • Edwards, Elizabeth1
  • Livanos, Maria1
  • Krueger, Anja2
  • Dell, Anne2
  • Haslam, Stuart M2
  • Mark Smales, C3, 4
  • Bracewell, Daniel G1
  • 1 Department of Biochemical Engineering, University College London, London, UK.
  • 2 Department of Life Sciences, Imperial College London, London, UK.
  • 3 School of Biosciences, Division of Natural Sciences, University of Kent, Canterbury, UK.
  • 4 National Institute for Bioprocessing Research and Training, Foster Avenue, Blackrock, Dublin, Ireland. , (Ireland)
Type
Published Article
Journal
Biotechnology and Bioengineering
Publisher
Wiley (John Wiley & Sons)
Publication Date
Jun 01, 2022
Volume
119
Issue
6
Pages
1343–1358
Identifiers
DOI: 10.1002/bit.28066
PMID: 35182428
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Glycosylation can be a critical quality attribute 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 γ-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 to establish holistic and consistent manufacturing processes for the production of antibody therapies. © 2022 The Authors. Biotechnology and Bioengineering published by Wiley Periodicals LLC.

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