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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 inhibitory activity of TNFα against 5 kinds of therapeutic mAb and its analogs targeting TNFα. Methods: Anti-TNFαrhmMcAb was used as a reference substance and TNFα anti-tumor activity was measured by TNFα cytotoxicity inhibition. The dose-response curves were fitted to four parameters and then measured for half effective inhibition of 1.0 ng · mL-1 TNFα Concentration (EC50). The relative activity of the sample was calculated by dividing the EC50 value of Anti-TNFa rhmMcAb by the EC50 value of the test sample. Results: The TNFα-killing activity of TNFαⅡR-Fc, Anti-TNFαrhuMcAb, Anti-TNFαsrhmMcAb and Anti-TNFαarhuM-cAb were 4860%, 248%, 505% and 90%, respectively, against Anti- TNFαrhmMcAb. CONCLUSION: The anti-TNFα anti-TNFα monoclonal antibody and its analogues can be used to determine the anti-TNFα cytotoxic activity of TNFα in vitro. The biological activity of different preparations can be evaluated according to the determination results And compare.