重组抗体药物的质量控制  

Quality control for recombinant therapeutic antibodies

作　　者：高凯[1] 陶磊[1] 王军志[1] 

机构地区：[1]中国食品药品检定研究院重组技术产品室,北京100050

出　　处：《中国新药杂志》2011年第19期1848-1855,共8页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2009ZX09307-001);国家高技术研究发展计划(863计划)(2007AA021601;2007AA021204)

摘　　要：重组抗体药物是生物工程关键技术的前沿成果,在肿瘤、自身免疫、器官移植和感染性疾病的治疗中均取得了显著疗效,在生物技术药物市场中的比重也在迅速攀升。作为生物技术产业化领域最成功的产品之一,如何通过质量控制确保抗体药物的安全有效一直是本领域的关注热点。文中就重组抗体药物质量控制的关键环节、进展及未来需要进一步开展的工作作一简要综述。Recombinant therapeutic antibodies are one of the great achievements of modern biotechnology. There is no doubt that the uses of recombinant therapeutic antibodies were successful in treating various life-threatening and chronic diseases, including cancer, autoimmunity, transplantation and infectious diseases. Its share in the global biopharmaceutical market also increased rapidly in recent years. Meanwhile, as one of the most success- ful outcome biotherapeutics, how to ensure the safety and efficacy of recombinant antibody products through well established quality control system is always the focus of attention from both the views of regulatory authorities and industries. This article briefly reviewed the key points, research progress for the control of recombinant antibodies, as well as raised further work on quality control issues.

关 键 词：生物技术药物 重组抗体 质量控制 

分 类 号：R917[医药卫生—药物分析学]