Advances of the effects of antibody heterogeneity on the function and metabolism of monoclonal antibody drugs

WANG Chen; ZHANG Zhewen; LI Yingchun; ZHANG Xiquan; ZHAO Wei

doi:10.11665/j.issn.1000-5048.20170518

Journal of China Pharmaceutical University > 2017 > 48(5): 614-621. > DOI: 10.11665/j.issn.1000-5048.20170518

WANG Chen, ZHANG Zhewen, LI Yingchun, ZHANG Xiquan, ZHAO Wei. Advances of the effects of antibody heterogeneity on the function and metabolism of monoclonal antibody drugs[J]. Journal of China Pharmaceutical University, 2017, 48(5): 614-621. DOI: 10.11665/j.issn.1000-5048.20170518

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Advances of the effects of antibody heterogeneity on the function and metabolism of monoclonal antibody drugs

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Abstract

Antibody drugs often show “heterogeneity”, including the related isomers differing from one another in glycosylation, charge or molecular size. Most of these isomers come from post-translational modifications, such as aggregation, degradation, glycosylation, oxidation, deamidation or disulfide misfolding, of the recombinant protein in the “cell factories”. These modifications not only influence the quality, safety and efficacy of the antibodies, but also serve as an important indication of product quality throughout the whole process of antibody production. This paper reviews the relationship between glycoslation, charge and size heterogeneities of monoclonal antibodies and drug efficacy, safety, pharmacokinetics as well as immunogenicity, contributing to a better understanding of the relationship between antibody structure and function. It will provide some support and guidance for the research and development of antibody drugs, especially biosimilars.
- biosimilar,
- drug discovery,
- antibody heterogeneity,
- glycosylation

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Advances of the effects of antibody heterogeneity on the function and metabolism of monoclonal antibody drugs

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