抗体生产纯化技术

Antibody Production Technology

自1997年FDA批准第一个治疗淋巴癌的嵌合单抗药物Rituxan,Anti-CD-20抗体上市,并进入56个国家,至2007年,FDA已批准了20多种治疗性单抗药物,约一半用于治疗癌症,7个已成为年销售额超10亿美元的"炸弹药物"。而随着高细胞密度培养及表达技术:大规模培养的表达水平从1g/L到5g/L;细胞的培养规模越来越大从12000L到15000L和在建的20000L细胞培养规模,同时多个细胞培养罐并行运行;这些都极大地推动了大规模蛋白质纯化技术的发展:从批产几公斤到年产几十公斤抗体,发展到批生产几十公斤至年产上十吨抗体的规模。同时,新型凝胶技术、更大规模的纯化生产系统技术和膜过滤技术的发展,使经典的三步层析技术能够缩短到两步层析技术生产抗体,进一步节约了投资,提高了产能和产率。详细介绍了最新发展的两步层析主导的一条完整抗体生产纯化解决方案。

Ever from FDA approved the Rituxan in 1997, an Anti-CD-20 chimeric antibody, there have been more than 20 antibodies approved and they have got into more than 56 countries. About half approvied antibodies are curing kinds of cancers and seven of them have got a excellent sale targets to be ＂Blockbuster Drug＂. As the cell culture technology improving, the large scale cell expression titer comes from 1 g/L to 5g/L. At the same time, the culture scale is coming form 12,000L to 15,000L, even 20000L and it can run several bioreactors at the same time. All these are make the improvement of the antibody purification. The new edition of media, system, chromatography technology and filtration technology can product the protein to several tens kilogram antibody per cycle and tons per year, although the productivity is only several kilograms per cycle many years ago. Also the new combined technology makes a two-step chromatography production protocol come into been. This will highly improve the antibody productivity and save the investment cost.