膜科学与技术

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Research progress on applications of membrane technology in separation and purification of monoclonal antibodies

Authors： ZHANG Hao, ZHANG Junyi, WU Haoran, YANG xin, FAN Rong, CHEN guoqiang, CHEN xiangrong, LUO Jianquan, WAN Yinhua

Units： 1. State Key Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, University of Chinese Academy of Sciences, Beijing 100190, China 2. School of Chemistry and Biological Engineering, University of Science and Technology Beijing, Beijing 100083, China

KeyWords： biological macromolecule drugs; membrane separation technology; monoclonal antibody; biomedical separation membrane; membrane fouling

ClassificationCode：TQ051.8

year,volume(issue):pagination： 2023,43(5):150-158

Abstract：

Biological macromolecule drugs play an essential role in disease diagnosis, treatment, and prevention. Their biological activity, purity, quality, and production cost are highly dependent on the performance of the downstream purification process. Thereinto, membrane separation technology possesses the advantages of no phase change, high efficiency, high selectivity, and mild operating conditions, which is widely applied in the purification of biological macromolecule drugs. Recent progress and challenges of membrane technology in monoclonal antibody clarification, capture, purification and polishing, and pre-formulation have been examined, which include depth filtration, membrane chromatography and equipment, membrane for virus removal and ultrafiltration/diafiltration process for protein concentration and buffer exchange. Finally, the conclusion and prospects of the applications of membrane technology in the separation and purification of biological macromolecule drugs have been provided.

Funds：

国家重点研发计划（2022YFC2105103）；国家自然科学基金项目（22178352）；

AuthorIntro：

张昊（1994-），男，甘肃靖远人，助理研究员，博士，从事膜过程功能化和集成化研究. E-mail: zhanghao@ipe.ac.cn

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