The 21st century is regarded as the century of biotechnological drugs, among which monoclonal antibodies and their derived targeting drugs have established themselves as the leading modality of biopharmaceutical pharmaceutics for a wide range of indications covering malignant tumors and autoimmune disorders. Since the manufacturing of the first antibody drug from hybridoma cells, the technologies have been intensely studied and there emerged numerous breakthroughs in recombinant cell line establishment, antibody expression and purification, quality control and other related areas. This article summarizes the critical progresses of antibody drugs expression technologies, especially of mammalian cell expression system, Escherichia coli expression system, the transgenic animal reactor and the cell free protein synthesis system, to give a detailed illustration of the recent advances in antibody drugs development.
生物技术药物是21 世纪医药工业发展的中坚力量，其中单克隆抗体类药物是生物技术药物的典型代表，是恶性肿瘤、自身免疫病等领域全球销售额最高的药品种类。在抗体药物发展的几十年里，随着基因工程、蛋白质工程等领域的发展，抗体生产的宿主细胞建立、表达、纯化等各阶段的技术均不断取得突破，文中综述和讨论了抗体药物生产所采用的真核哺乳动物细胞表达系统、原核大肠杆菌表达系统、转基因动物反应器、无细胞蛋白质合成系统以及相关的关键技术进展。.
Keywords: CRISPR; antibody drugs; expression system; mammalian cells; manufacturing.