抗PD-1单抗生物学活性测定方法的联合验证

针对抗PD-1单抗的报告基因活性测定法开展实验室间的联合验证,以研究该方法多实验室间的可应用和可转移性。本文采用两种协作方案,分别对该方法的检测内、检测间和实验室间精密度以及线性和准确性进行了研究。结果显示:该方法的检测内精密度的95%可置信区间为(1.72～16.89)%,检测间精密度为(2.63～17.67)%,实验室间精密度为(9.00～14.26)%;线性的相关系数均大于0.99,对于不同效价水平准确性的95%可置信区间, 50%为(91.83～104.40)%, 75%为(90.40～101.40)%, 100%为(94.71～105.60)%, 125%为(94.00～102.00)%, 150%为(96.73～104.30)%。联合验证结果证明,该针对抗PD-1单抗的报告基因测活法,其精密度、线性和准确性均良好,可应用于不同实验室抗PD-1单抗的放行检测及稳定性分析。

Collaborative study to evaluate a reporter gene assay for anti-PD-1 antibody bioactivity

A collaborative inter-laboratory validation was carried out using a reporter gene assay to measure the bioactivity of anti-PD-1 monoclonal antibody, in order to study the applicability and transferability of the method. In this study, two collaborative schemes were designed to measure the precision, linearity and accuracy of the method. The results showed that the 95% confidence interval(CI) of the intra-assay precision was(1.72-16.89) %, inter-assay precision was(2.63-17.67) %, inter-laboratory precision was(9.00-14.26) %, all linear correlation coefficients were greater than 0.99, and the 95% CI for the accuracy at different potency levels was(91.83-104.40) % at 50%,(90.40-101.40) % at 75%,(94.71-105.60) % at 100%,(94.00-102.00) % at 125%, and(96.73-104.30) % at 150%. The collaborative validation results proved that the reporter gene assay for the bioactivity determination of anti-PD-1 monoclonal antibody has good precision, linearity and accuracy, and could be applied to the release and stability analysis of anti-PD-1 monoclonal antibodies in different laboratories.