单克隆抗体类药物体外生物学活性检测方法概述  

Progress of in vitro Bioactivity Determination of Monoclonal Antibody-based Drugs

作　　者：黄秋歌 于红阳 王红丽 徐明波 窦洁[1] 杨仲璡 HUANG Qiu-ge;YU Hong-yang;WANG Hong-li;XU Ming-bo;DOU Jie;YANG Zhong-fan(School of Life Science and Technology,China Pharmaceuiical University,Nanjing 210009,China;Beijing SL Pharmaceutical Co.,Ltd.,Beijing Engineering Research Center of Recombinant Protein and Long-acting Preparation,Beijing 100143,China)

机构地区：[1]中国药科大学生命科学与技术学院,江苏南京210009 [2]北京双鹭药业股份有限公司,北京市重组蛋白及其长效制剂工程技术研究中心,北京100143

出　　处：《药物生物技术》2020年第3期286-290,共5页Pharmaceutical Biotechnology

摘　　要：单克隆抗体因其具有特异性、高效性以及低毒副作用的特点而在恶性肿瘤、自身免疫疾病以及器官移植排斥的治疗上占据了非常重要的地位,成为众多药企的研发目标。单克隆抗体类药物的体外生物学活性检测是其质量控制中至关重要的一环。单克隆抗体类药物的生物学活性检测方法主要有细胞增殖抑制法、细胞毒性法、抗体依赖的细胞介导的细胞毒性法(ADCC)、补体依赖的细胞毒性法(CDC)和报告基因法等几类方法。文章根据单克隆抗体类药物的作用特点分别对靶向肿瘤细胞单抗类药物、靶向细胞因子单抗类药物、靶向免疫细胞或者免疫检查点相关分子单抗类药物及抗体偶联药物和双特异性抗体等其他单抗类药物的体外生物学活性的检测方法进行综述。Monoclonal antibodies,because of their specificity,high efficiency and low toxicity,have played an important role in the treatment of malignant tumors,autoimmune diseases and organ transplant rejection,and become the research and development targets of manypharmaceuticalcompanies.The in vitro bioactivity assay of monoclonal antibody drugs is a.crucial part of their quality control.Methods for detecting the biological activity of monoclonal antibodies include cell proliferation inhibition,cytotoxicity,antibody-dependent cell-mediated cytotoxicity,complement-dependent cytotoxicity,and reporter gene.In this paper,according to the functional characteristics of monoclonal antibodies,the methods for the detection of in vitro biological activities of targeted tumor cell monoclonal antibodies,targeted cytokine monoclonal antibodies,targeted immune cells or immune checkpoint related molecular monoclonal antibodies and other monoclonal antibodies including antibody drug conjugates and bispecific monoclonal antibodywere reviewed.

关 键 词：单克隆抗体类药物 生物学活性检测 细胞增殖抑制 抗体依赖的细胞介导的细胞毒性 补体依赖的细胞毒性 荧光素酶报告基因 

分 类 号：R977.6[医药卫生—药品]