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目的对单克隆抗体制品中残余SP2/0细胞蛋白含量ELISA检测试剂盒进行验证。方法对Cygnus Technologies公司制备的SP2/0Host Cell Protein(sHCPs)ELISA试剂盒进行灵敏度、精密性验证及基质干扰试验和样品稀释回收试验,并采用该试剂盒对本公司制备的10批单抗制品原液及冻干品进行检测。结果标准蛋白含量的对数与相应的光吸收值的对数,在2～200ng/ml范围内呈线性关系;该试剂盒检测限可达0.6ng/ml,定量限可达2ng/ml,灵敏度符合要求;检测低、中、高3个浓度的SP2/0HCPs样品试验内及试验间变异系数分别为15.4%、3.0%、2.1%及12.0%、3.3%、1.5%;样品基质对检测无明显干扰;单抗样品检测不存在Hook效应;检测本公司10批单抗制品原液和冻干品中SP2/0细胞蛋白残留率均小于0.01%。结论该试剂盒灵敏度高,精密性好,可用于单抗制品中残余SP2/0细胞蛋白含量的测定。
Objective To verify the ELISA kit for residual SP2 / 0 cell protein in monoclonal antibody preparations. Methods The sensitivity and precision of SP2 / 0 Host Cell Protein (sHCPs) ELISA kit prepared by Cygnus Technologies were tested, as well as the matrix interference test and the sample dilution recovery test. The kit was used to prepare the 10 batches of monoclonal antibody Lyophilized product for testing. Results The logarithm of the standard protein content was logarithmically related to the logarithm of the corresponding light absorbance in the range of 2 ~ 200ng / ml. The detection limit of the kit was 0.6ng / ml, the limit of quantification was 2ng / ml, the sensitivity The results showed that the coefficient of variation (CV) within and between the two tests were 15.4%, 3.0%, 2.1% and 12.0%, 3.3% and 1.5%, respectively. Interference; monoclonal antibody sample test does not exist Hook effect; detection of the company 10 batches of monoclonal antibody products and lyophilized SP2 / 0 cell protein residues were less than 0.01%. Conclusion The kit has high sensitivity and good precision and can be used to determine the residual protein content of SP2 / 0 cells in monoclonal antibody.