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
分类号：
出版年·卷·期（页码）：2012,32 (5):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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-TNFα rhmMcAb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-TNFα rhmMcAb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-TNFα rhmMcAb,TNFαⅡR-Fc、Anti-TNFα rhuMcAb、Anti-TNFα srhmMcAb和Anti-TNFα arhuMcAb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。
-----英文摘要：---------------------------------------------------------------------------------------
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.
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