动物细胞大规模培养生产蛋白的工艺选择  

Industrial Choices for Protein Production by Large-scale Animal Cell Culture

作　　者：米力[1] 陈志南[1] 

机构地区：[1]第四军医大学细胞工程中心国家863西安细胞工程基地,西安710032

出　　处：《中国生物工程杂志》2003年第7期1-6,共6页China Biotechnology

基　　金：国家重大科技专项 ( 2 0 0 2AA2Z3 441)

摘　　要：目前全世界蛋白治疗药物的迅速增长和市场需求已远远超过了现有生产能力。动物细胞规模化生产重组蛋白和抗体的工艺选择可考虑使用当前较成熟的工业化支持技术平台 ,以缩短产品工艺研发的时间 ,加快工业化进程。当前被FDA批准的生物技术产品以及公开发表的生产工艺占有主流优势的是搅拌式生物反应器悬浮培养 ,工艺设计是流加或灌流培养。其大规模细胞培养生产所面临的挑战是获得最大生产力的同时注重维持产品的质量 ;去除所有培养环境中外源因子的污染 ,更为精确有效的工艺控制手段 ,规模化培养中氧气的限定与溶解CO2 浓度累积的控制等。The therapeutic grade protein has grown rapidly nowadays,and the market requirement has far exceeded production scale. Mammalian cell-culture production of recombinant proteins and antibodies indicates that industry has converged on using suspension cultures in stirred-tank bioreactors with some form of controlled feeding (e.g. fed-batch or perfusion).Recently approved FDA BLAs and the published literature both suggest that companies may be considering the use of platform technologies to speed up process development timelines.Large-scale cell-culture production is still faced with significant challenges —maximizing productivity while maintaining product quality, removing all animal derived components from cell-culture medium, and controlling carbon dioxide removal.

关 键 词：动物细胞 大规模培养 蛋白 生产工艺 生物制药 

分 类 号：Q813.1[生物学—生物工程]