关键词: 单克隆抗体, 电荷异质性, 工艺开发

Abstract: Recombinant monoclonal antibody drugs are mostly post-translationally modified and the types are complex and diverse. Therefore, quality control during the development process is particularly important. Among them, charge heterogeneity is a critical quality attribute, which may affect the efficacy of biological products, and may even bring unexpected side effects, which will affect the safety and effectiveness of the drug. Therefore, it is necessary to focus on and pay attention to the development of mAb regulation. Post-translational modification of monoclonal antibody drugs is the main cause of charge heterogeneity. Therefore, control of charge heterogeneity is an important challenge for the development of biopharmaceutical technology. This article reviewed the characterization methods of charge heterogeneity, and summarized the post-translational modifications of proteins that can cause charge heterogeneity according to its classification. At the same time, the paper described the safety and effectiveness of different charge heterogeneity for antibody drugs. Finally, the latest progress of charge heterogeneity process control strategy in process development was summarized. We hope to give inspiration to researchers in the development and quality of biopharmaceutical processes.

Key words: monoclonal antibody, charge heterogeneity, process development