重组单克隆抗体药物的工程细胞培养工艺研究  

Progress in engineering cell culture process in production of recombinant monoclonal antibody drugs

作　　者：汪艳艳 毛晓燕 WANG Yan-yan;MAO Xiao-yan(Fourth Department of Research, Lanzhou Institute of Biological Products Co., Ltd., Center forGansu Provincial Vaccine Engineering Research, Lanzhou 730046, Gansu Province, China)

机构地区：[1]兰州生物制品研究所有限责任公司第四研究室甘肃省疫苗工程技术研究中心

出　　处：《微生物学免疫学进展》2019年第5期79-85,共7页Progress In Microbiology and Immunology

摘　　要：单克隆抗体(monoclonal antibody, mAb)是一类重要的基因工程生物技术衍生药物,其药物适应证包括自身免疫性疾病、移植后并发症、心血管疾病、感染性疾病和各种类型的癌症。此类适应证药物通常使用时间长、使用剂量大,因此需具备大批量生产的能力。由于mAb药物的生产成本以及产品质量控制的复杂性,要求有效且经济地提供批间一致性较好的高质量药物。中国仓鼠卵巢(Chinese hamster ovary, CHO)细胞是生物技术产业中用于生产治疗性糖蛋白最常用的真核表达宿主,也是生产治疗性抗体药物最常使用的细胞。在细胞培养过程中,工程细胞株、培养基和工艺条件是mAb药物生产中影响其质量的三个重要因素。现分别从培养基、培养参数和培养模式等对生产mAb药物的细胞培养技术作一概述。Monoclonal antibodies (mAbs) are an important part of biotechnologically derived drugs, its approved therapeutic indications include auto-immune diseases, post-transplant complications, cardio-vascular diseases, infectious diseases and various types of cancers.It is important to have a large-scale production capacity, because monoclonal antibody drugs are used in high-doses in most of these treatments for a long time.Thus there is a strongly growing demand for efficient and economical delivery of consistently high quality drugs, it is crucial to solve the commercial production costs and the complexity of product quality control of monoclonal antibody drugs.Chinese hamster ovary (CHO) cells are the most commonly used eukaryotic expression hosts for the production of therapeutic glycoproteins in the biotechnology industry.In the cell culture process, cell strains, media and cultivation conditions are three important aspects in the production of mAbs, which affect their quality properties.This review summarizes the cell culture techniques for mAbs production including culture medium, culture parameters and culture patterns.

关 键 词：中国仓鼠卵巢细胞 单克隆抗体 工艺 培养基 参数 

分 类 号：R392.12[医药卫生—免疫学]