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目的建立猕猴血清中重组人源化抗EGFR单克隆抗体的测定方法,为药代动力学研究提供简单快速的方法。方法采用EGFR包外区包被酶标板、HRP标记的IgG-Fc段为标记抗体,建立定量检测抗EGFR单克隆抗体的间接ELISA法,并对其特异性、精密度、准确度、稳定性和稀释效应进行确证。结果在0.46～14.56ng·mL-1浓度范围内,测定方法具有较好的logistic曲线拟合关系,最低检测限为0.46ng·mL-1,组内及组间精密度的RSD分别为6.10%～9.81%,10.17%～11.93%。结论该方法简便、准确、特异性强,精密度及准确度均符合药代动力学要求,可用于猕猴及人血清中抗EGFR单克隆抗体的检测。
Objective To establish a method for the determination of recombinant humanized anti-EGFR monoclonal antibody in the serum of cynomolgus monkeys and provide a simple and rapid method for the study of pharmacokinetics. Methods The ELISA kit was used to coat the outer surface of EGFR and the IgG-Fc fragment labeled with HRP was used as the labeled antibody to establish an indirect ELISA for the quantitative detection of monoclonal antibodies against EGFR. The specificity, precision, accuracy and stability And dilution effect to confirm. Results In the range of 0.46 ~ 14.56ng · mL-1, the determination method has a good logistic curve fitting, the minimum detection limit was 0.46ng · mL-1, the RSD of the intra- and inter-group precision was 6.10% ~ 9.81%, 10.17% ~ 11.93%. Conclusion The method is simple, accurate, specific, precision and accuracy are in line with pharmacokinetic requirements, can be used for the detection of anti-EGFR monoclonal antibodies in rhesus monkeys and human serum.