抗体收获澄清技术及工艺影响因素  

Clarification technologies and factors that impact the work stream for antibody harvest

作　　者：马春花 Ma Chunhua(China Technology Center(Beijing),3M China Ltd.,Beijing 100176,China)

机构地区：[1]3M中国有限公司北方技术中心,北京100176

出　　处：《国际生物制品学杂志》2023年第2期115-120,共6页International Journal of Biologicals

摘　　要：随着抗体生产上游工艺强化,细胞培养密度增加、抗体表达滴度提高,对收获澄清工艺造成前所未有的挑战。抗体收获澄清的工艺质量直接影响到下游纯化、精纯及最终抗体的产量和质量。此文整理并介绍了目前业内常用的抗体/重组蛋白收获澄清技术的优缺点和适用性,并重点介绍了新型收获澄清技术,如层析式澄清技术;进一步分析了影响收获澄清工艺方案确定的主要因素:适用性(浊度、处理量、收率、处理规模)、澄清效率和经济效益。深层过滤技术在浊度控制、载量、收率和效率方面均具备一定优势,是目前抗体/重组蛋白收获澄清工艺应用最广泛的技术,但也有其应用局限性。生产商需要结合项目特点、自身资源及综合成本对收获澄清技术进行全面考察。With the enhancement of upstream process of antibody production,cell culture density and antibody expression titer increase,which poses unprecedented challenges to harvest clarification process.The quality of the harvest and clarification process of antibody directly affects the downstream purification and polishing train,as well as the final yield and quality of the antibody production.This paper reviews the advantages,disadvantages and applicability of the harvest and clarification technologies that are commonly used in the industry for antibody/recombinant protein production,in particular the new harvest and clarification technologies such as chromatographic clarification.The main factors affecting the determination of the harvest and clarification process are further analyzed:applicability(turbidity,throughput,recovery,capacity),clarification efficiency and economic benefit.Depth filtration technology is superior in turbidity control,throughput,recovery and efficiency,so it is the most widely used antibody/recombinant protein harvest and clarification technology in the industry,though still has limitations.Manufacturers need to take into account the characteristics of the project,their own resources and comprehensive cost to evaluate certain harvest and clarification technology.

关 键 词：典型收获澄清技术 深层过滤 离心 微孔过滤 层析式澄清技术 经济效益 

分 类 号：Q819[生物学—生物工程] Q816[医药卫生] R-331R-1