治疗性单抗与抗体产业关键技术  

The Progress of Therapeutic Antibody Drug and the Industrial Key-technology of Antibody Production

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050021

出　　处：《中国生物工程杂志》2013年第5期132-138,共7页China Biotechnology

基　　金：国家"973"计划(2012CB724502)资助项目

摘　　要：抗体技术历经动物血清多克隆抗体、杂交瘤单克隆抗体,以及重组基因工程抗体等不同发展时期,尤其是后者使得治疗性抗体的生产进入产业化阶段。在已上市的抗体药物中,人源化抗体、全人源抗体由于免疫原性小,临床药效好,目前已经成为抗体药物的主流。随着抗体药物在癌症、免疫调节等治疗领域的广泛应用。抗体产业已经成为国际制药行业的主要组成部分。我国的抗体产业由于品种不足、技术落后,尚处于起步阶段,其行业发展受限于诸多技术瓶颈,如:工程细胞系构建与筛选、大规模培养工艺开发,单抗的纯化与质控等,上述产业化关键技术的突破可加快我国抗体产业的发展进程。The development of therapeutic antibody technology has experienced with three stage including polyelonal antibody from antiserum, monoclonal antibody from hybridoma, and the recombinant antibody technology. Moreover, the recombinant antibody technology ensures therapeutic antibody possible to commercial manufacturing. Owing to lower immunogenicity and higher clinic efficacy, the humanized and full human antibodies have been dominant in approved antibody drug, instead of mouse or chimeric antibodies. With successes in the cancer and autoimmunity therapy, the antibody industry has become primary component pharmaceutical in the world. According to the industry capacity and launched antibody products, the China antibody industry was in initial stage. Further, the technology bottleneck limiting antibody drug industrialization was identified, which involved with establishment of antibody-producing cell line, process development of large scale cell culture, and purify and quality control of antibody product. The development of industrial key- technology, mentioned above, will accelerate the process of antibody industry in china.

关 键 词：重组抗体 抗体药物 抗体产业 抗体制备工艺 

分 类 号：Q511[生物学—生物化学]