摘要
近年来抗体药物在生物医药领域发展迅速。随着抗体疗法种类的不断增加和PD-1/PD-L1靶点蛋白结构的确证,临床上,越来越多针对PD-1/PD-L1免疫检查点的单克隆抗体药物被不断开发并应用于治疗死亡率高、治愈率低的多种癌症中。但是抗体药物制剂开发水平还需进一步提高,一方面同一靶点的抗体产品同质化严重,另一方面抗体药物的理化性质比小分子药物复杂,因此需要针对不同单克隆抗体的药物特性,筛选出适应于临床应用的稳定蛋白制剂处方。概括了不同抗体药物制剂处方成分(缓冲液成分、药物辅料)的作用,结合PD-1/PD-L1靶点介绍了抗体药物制剂稳定性开发的一般策略以及CDE相关的审评要点。
Recently,antibody drugs have developed rapidly in the field of biopharmaceuticals.Clinically,the type and number of monoclonal antibody-based tumor therapies are increasing.With confirmed structure of PD-1/PD-L1 protein,monoclonal antibody drugs against immune checkpoint PD-1/PD-L1 have been continuously developed and applied to the treatment of many principal cancers with high mortality and low cure rate.However,due to the complex physical and chemical properties and serious homogenization,monoclonal antibody drugs are necessary to screen out stable protein preparations for clinical applications based on the characteristics of different monoclonal antibody drugs.This article reviews the role of different antibody drug formulations(buffer components,drug excipients),combined with the PD-L1 target,which introduces the stability development of antibody drug formulations and the main points for evaluation of CDE.
作者
吝建华
韩君
徐寒梅
LIN Jian-hua;HAN Jun;Xu Han-mei(China Pharmaceutical University,Nanjing 211198,China;Tasly Biopharmaceuticals Co.,Ltd.,Shanghai 201203,China)
出处
《中国生物工程杂志》
CAS
CSCD
北大核心
2020年第10期35-42,共8页
China Biotechnology
