Strategies to control therapeutic antibody glycosylation during bioprocessing: Synthesis and separation.
Biotechnol Bioeng
; 119(6): 1343-1358, 2022 06.
Article
em En
| MEDLINE
| ID: mdl-35182428
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.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Medicamentos Biossimilares
/
Antineoplásicos Imunológicos
Limite:
Animals
Idioma:
En
Revista:
Biotechnol Bioeng
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Reino Unido