Research Progress

Glycation Modifi cation of Monoclonal Antibody Drugs and Its Impact

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  • (1)National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,Beijing 102629 ,China; (2)National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Rese

Online published: 2023-02-18

Abstract

Objective: To review the formation and detection of glycation of monoclonal antibody (mAb) and its impact on the functional activity of mAb, so as to provide references for the industry. Methods: Through literature retrieval, the research on glycation of mAbs at home and abroad was summarized. Results and Conclusion: Glycation mainly occurs in the cell fermentation stage, and the degree and rate of glycation are affected by multiple factors. Glycation modifi cation may aff ect the heterogeneity, bio-functions and immunogenicity of mAbs. The pharmaceutical research and evaluation of glycation are usually ignored in domestic R&D companies. It is suggested that the impact of glycation should be fully evaluated and whether it is a key quality attribute should be determined during the development of mAb, and it should be eff ectively controlled and monitored.

Cite this article

Wang Wenbo, Xia Xijie, Wu Gang, Xu Gangling, Yu Chuanfei, Wang Lan . Glycation Modifi cation of Monoclonal Antibody Drugs and Its Impact[J]. Chinese Pharmaceutical Affairs, 2023 , 37(2) : 231 -238 . DOI: 10.16153/j.1002-7777.2023.02.016

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