用于重组抗体生产的细胞大规模培养技术  

The Lasted Development of Large Scale Cell Culture Technology for Commercial Antibody Manufacture

作　　者：刘伯宁[1] 

机构地区：[1]华北制药集团新药研究开发有限责任公司抗体药物研制国家重点实验室,石家庄050015

出　　处：《中国生物工程杂志》2013年第7期103-111,共9页China Biotechnology

基　　金：国家"973"计划资助项目(2012CB724502)

摘　　要：近年来,用于单抗药物生产的动物细胞大规模培养技术发展迅速。此领域的技术进展集中在个性化培养基开发,工艺条件优化等方面。本文总结了用于提高重组抗体表达水平的常用方法,以及细胞培养工艺对抗体药物"关键质量属性"(聚体、降解、糖基化修饰、电荷变异等)的诸多影响。此外,细胞培养工艺在产业化过程面临着工艺放大与技术转移,定性研究与工艺验证等实际问题。未来大规模细胞培养工艺的开发,将进一步借助动物细胞的组学研究成果和新兴的"过程分析技术"。Large scale animal cell culture technology has leaped forward in the lasted years.The state-of-art of cell culture process development for commercial monoclonal antibody production,which is involved with medium optimization methodology and process development of fed batch/perfusion mode,was discussed in detail.Some methods and compositions used for improving recombinant yield and impact of cell culture process on critical quality attribute of recombinant antibody(such as: aggregate、degradation、glycosylation,charge heterogeneity)were summarized and illustrated by cases.Additional,some topic involved with cGMP manufacturing was addressed,including process characterization and validation.It can been forecasted that the omics research of animal cell and PAT(process analysis technology) will accelerate process development of large scale cell culture.

关 键 词：重组抗体 细胞大规模培养 培养基优化 工艺开发 

分 类 号：TQ460.6[化学工程—制药化工]