【摘要】 随着重组抗体药物展示出良好的治疗效果和市场效益,抗体药物的研发逐渐成为生物医药产业发展的主要方向。但是目前国内动物细胞表达水平普遍较低和发酵工艺落后的现状制约了我国抗体药物产业化的发展。主要综述了国际抗体药物产业的发展态势,重点比较二氢叶酸还原酶和谷氨酰胺合成酶表达体系、连续灌注和流加培养发酵模式的各自优势,结合我们抗体药物表达、发酵方面的经验,对当前我国抗体药物产业化发展策略进行了探讨,提出抗体药物产业化模式应根据企业对抗体产率、产能和市场经济学的多重考虑选择发酵工艺和发酵规模,应用谷氨酰胺合成酶/CHO-K1表达系统和连续灌注培养工艺可能更适应目前中国抗体产业化的需要。更多还原

【Abstract】 Recombinant antibodies have become the major growth trends in biotech industry following their success on therapeutic application and good revenue. But the low level of mammalian expression and laggard fermentation process constrained the development of antibody industry in China. The global advances of antibody industry were reviewed, compared the respective advantage between dihydrofolate reductase and glutamine synthetase expression system, continuous perfusion and fed-batch processes were compared. Finally, based on the knowledge and experience of antibody expression and fermentation, the suitable strategy of antibody industrialization, e.g. the fermentation model and scale, should depend on the comprehensive consideration of entrepreneur for the productivity, manufacturing capacity and market revenue. It may be a wise choice to use glutamine synthetase expression system and continuous perfusion process for the need of Chinese antibody industrialization.更多还原