摘要目的:验证抗狂犬病毒单克隆抗体(单抗)中残留宿主细胞蛋白(host cell protein，HCP) ELISA定量检测方法。方法:使用商用中国仓鼠卵巢细胞HCP残留ELISA检测试剂盒，测定2种针对不同表位的抗狂犬病毒单抗原液中的残留HCP，并验证该方法的专属性、准确度、精密度、线性、耐用性、检测限及定量限。结果:2种抗狂犬病毒单抗发酵液稀释10 000倍后检出的HCP含量分别为31.42和19.36 ng/ml。制剂溶液、HEK293F和 E. coli培养上清液中未检出HCP。3种浓度的HCP加标供试品的加标回收率均在80%～120%之间。3种浓度的HCP加标供试品重复性检测结果及中间精密度检测结果相对标准偏差均<20%。分别对3次残余HCP检测绘制四参数标准曲线，决定系数均>0.990。在一定范围内改变孵育时间和显色时间，HCP测定结果在合理的偏差范围内。检测限和定量限分别为2和3 ng/ml。 结论:抗狂犬病毒单抗中HCP残留量的ELISA定量检测方法专属性、准确度、精密度、线性及耐用性良好。

abstractsObjective:To verify a quantitative ELISA in determination of the residual host cell protein (HCP) in anti-rabies virus monoclonal antibody (mAb).Methods:The commercial Chinese hamster ovary cell HCP ELISA kit was used to determine the residual HCP in the stock solution of 2 anti-rabies virus mAbs targeting different epitopes, and the specificity, accuracy, precision, linearity, robustness, limit of detection(LOD) and limit of quantitation (LOQ) of the method were verified.Results:The HCP content detected after diluting the fermentation broth of 2 anti-rabies virus mAbs by 10 000 times was 31.42 and 19.36 ng/ml, respectively. HCP was not detected in the preparation solution, and the culture supernatant of HEK293F and E. coli.The recoveries of the spiked samples with 3 different HCP concentrations were between 80% and 120%. The relative standard deviation of the repeatability test results and the intermediate precision test results of the spiked samples with 3 different HCP concentrations were all<20%. The four-parameter standard curves were drawn for 3 HCP residual tests respectively, and coefficient of determination were all>0.990.The HCP test results were within a reasonable deviation range when the incubation time and the developing time were changed in a certain range. The LOD and LOQ were 2 and 3 ng/ml, respectively. Conclusion:A quantitative ELISA detection method for residual HCP in anti-rabies virus mAb is verified, which shows good specificity, accuracy, precision, linearity, and robustness.