单克隆抗体类药物的免疫原性分析  

Immunogenicity analysis of monoclonal antibody drugs

作　　者：宋文娅[1] 石远凯[1] 韩晓红[1] 

机构地区：[1]国家癌症中心/中国医学科学院北京协和医学院肿瘤医院,北京100021

出　　处：《中国新药杂志》2016年第21期2462-2465,共4页Chinese Journal of New Drugs

基　　金：国家重大新药创制科技重大专项资助项目(2012ZX09303012);国家高技术研究发展计划(863计划)资助项目(2011AA02A110);北京市科委重大项目(D141100000214003;D141100000214005)

摘　　要：随着精准医学时代的到来,单克隆抗体(简称单抗,monoclonal antibodies,m Abs),因其高度特异性及易于生产而成为生物类药物治疗的热点。目前其已在肿瘤、移植排斥、自身免疫性疾病和器官移植排斥等多个领域取得了显著的临床疗效,极大地提高了患者的生命质量。随着单抗类药物的种类增多及广泛的应用,与其相关免疫原性问题也逐渐浮出水面,引起人们的高度关注。本文就单抗的免疫原性及其分析与评价方法、改善措施及目前存在的问题进行论述,以期更好地指导单抗类药物的临床应用。Following the era of precision medicine,monoclonal antibody（ m Ab） drugs have been hot issues of biotherapeutic drugs,because of its high specificity and simplicity of manufacture. Currently,they have achieved significant clinical efficacy in the field of malignancies,transplant rejection,autoimmune and infectious diseases,and greatly improved the quality of patients＇ life. As there are more varieties of m Ab drugs and its extensive use,the problems about immunogenicity of m Ab drugs have gradually come up to the surface,and raised highly concern. Here,the detection and evaluation methods,improvement measures and some issues of immunogenicity were described,which could be a better guide in clinical applications.

关 键 词：单克隆抗体 免疫原性 抗体人源化 分析方法 安全性 

分 类 号：R979.1[医药卫生—药品]