An international collaborative research to evaluate the reference substance of anti-human EPO monoclonal antibody / 中国药学杂志

ABSTRACT

OBJECTIVE: To assess a panel of 9 human monoclonal antibodies against human erythropoietin (EPO) with defined characteristics (non-neutralizing, neutralizing, affinities) for suitability for EPO antibody assays. METHODS: A multi-center collaborative study involving three different laboratories and different assay platforms was carried out. Direct ELISA was used to test the affinities of the samples by Shenyang Sunshine pharmaceutical Co., Ltd and National Institutes for Food and Drug control, while indirect ELISA was used by Xiamen amoytop biotech Co., Ltd. The neutralizing assays were performed using UT-7 cell line by all the three laboratories. RESULTS: The properties of the 9 human monoclonal antibodies against human erythropoietin were assessed efficiently by all the three laboratories using different METHODS. CONCLUSION: It is suggested that the EPO antibody panel is established to enable the evaluation of the performance of different EPO antibody assays and thus the selection of appropriate assay for clinical use.