规模化抗体药物生产纯化技术研究进展

Research Progress in Purification Technology of Antibody Drugs in Process of Large-Scale Production

抗体药物在现代医学强调精准治疗的背景下起着越来越重要的作用,特别是在肿瘤和自身免疫性疾病等领域的应用,显示了极高的临床价值。抗体药物正在改变包括癌症在内的多种疑难疾病的治疗观念。规模化抗体药物生产在我国仍有许多瓶颈要解决,而纯化过程是其重要环节,直接关系到抗体药物的质量、安全性、成本等多个方面。综述了规模化抗体药物生产纯化过程较为常用的澄清技术、层析技术、病毒灭活/去除技术等的研究现状,介绍了相关产品,以期为抗体药物临床试验和规模化生产提供帮助。

In the background of focusing on precision treatment in modern medicine,antibody drugs play more and more important roles.Especially antibody drugs show a high clinical value in the fields of cancer and autoimmune diseases.The application of antibody drugs is changing the concept of diagnosing and curing various difficult diseases including cancer.However,many problems still need to be solved in the large-scale production of antibody drugs in China.And purification process is an important part of the large-scale production of antibody drugs,which is directly related to the quality,safety,and cost of antibody drugs.Therefore,we review the research progress in common purification technology of antibody drugs in the process of large-scale production,including clarification,chromatograph,and inactivation/removal of virus,and introduce the corresponding products.We expect to provide supports for the clinical test and large-scale production of antibody drugs.