5种TNFα单抗及其类似物的TNFα杀伤抑制活性的比较  

TNFα cytotoxic inhibitory potency comparison of five anti-TNFα monoclonal antibody and its analog

作　　者：张峰[1] 郭玮[1] 刘春雨[1] 孟淑芳[1] 王佑春[1] 

机构地区：[1]中国食品药品检定研究院细胞室,北京100050

出　　处：《药物分析杂志》2012年第5期733-737,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：国家"重大新药创制"科技重大专项(2009ZX09307-001)

摘　　要：目的:比较5种以TNFα为治疗靶位的治疗性单抗及其类似物的TNFα杀伤抑制活性。方法:以Anti-TNFαrhmMcAb为参比品,采用TNFα杀伤抑制法测定其他4种制品的TNFα杀伤抑制活性,剂量-反应曲线进行四参数拟合后,测定抑制1.0 ng·mL-1TNFα杀伤的半数有效浓度(EC50)。以Anti-TNFαrhmMcAb的EC50值除以待测样品EC50值计算样品的相对活性。结果:相对于Anti-TNFαrhmMcAb,TNFαⅡR-Fc、Anti-TNFαrhuMcAb、Anti-TNFαsrhmMcAb和Anti-TNFαarhuM-cAb的TNFα杀伤抑制活性分别为4860%,248%,505%,90%。结论:TNFα杀伤抑制方法可以快速测定治疗性抗TNFα单抗及其类似物的TNFα杀伤抑制活性,不同制品的测定结果之间具有一定可比性,可以根据测定结果对不同制品的生物学活性进行评价和比较。Objective：To compare the TNFα cytotoxic inhibitory potency of five TNFα-targeted therapeutical monoclonal antibody and its analog.Methods： Took Anti-TNFα rhmMcAb as reference,the TNFα cytotoxic inhibitory potency of 4 other anti-TNFα products was tested with TNFα cytotoxic inhibitory method.The Dose-Response curve was modeled with 4-parameter pattern and 50% effective concentraion（EC50） against 1.0 ng·mL-1 TNFα was determined.The EC50 ratio of Anti-TNFα rhmMcAb to tested samples was calculated and assigned to tested samples as its relative potency.Results： The relative potency of TNFαⅡR-Fc,Anti-TNFα rhuMcAb,Anti-TNFα srhmMcAb and Anti-TNFα arhuMcAb was：4860%,248%,505% and 90%,respectively.Conclusions： TNFα cytotoxic inhibitory assay can determine the TNFα-targeted products’ biopotency,and there is comparability between different products.

关 键 词：靶位制剂 单克隆抗体 抗肿瘤坏死因子Α 生物学活性 活性比较 细胞杀伤抑制方法 

分 类 号：R917[医药卫生—药物分析学]