参与评价抗人促红细胞生成素单克隆抗体参考品国际协作国内部分的研究  

An International Collaborative Research to Evaluate the Reference Substance of Anti-Human EPO Monoclonal Antibody

作　　者：侯绪凤 陈伟[2] 廖小金 邵宝珠[1] 靳征[1] 吴汉洲 朱佩娟 周勇[2] HOU Xu-feng CHEN Wei LIAO Xiao-jin SHAO Bao-zhu JIN Zheng WU Han-zhou ZHU Pei-juan ZHOU Yong(Shenyang Sunshine Pharmaceutical Co., Lid, Shenyang 110027, China National Institute for Food and Drug Control, Beijing 100050, China Xiamen Amoytop Biotech Co., Lid, Xiarnen 361028, China)

机构地区：[1]沈阳三生制药有限责任公司,沈阳110027 [2]中国食品药品检定研究院,北京100050 [3]厦门特宝生物工程股份有限公司,福建厦门361028

出　　处：《中国药学杂志》2017年第3期235-239,共5页Chinese Pharmaceutical Journal

摘　　要：目的通过不同的检测平台和实验方法对9种抗人重组人促红细胞生成素(rh EPO)单克隆抗体的测试结果的比较,评价其在临床单纯红细胞再生障碍性贫血(pure red cell aplasia,PRCA)rh EPO免疫原性研究中应用的可行性。方法中国食品药品检定研究院(中检院)和沈阳三生制药有限责任公司(三生制药)采用直接ELISA评价待测参考品的结合性抗体性质,厦门特宝生物工程股份有限公司(特宝生物)采用间接ELISA评价待测参考品的结合性抗体性质;3家单位均采用EPO依赖细胞株UT7/EPO细胞的增殖抑制法评价待测参考品的中和性抗体性质。结果不同检测平台和检测技术均能对抗rh EPO单克隆抗体参考品的性质进行有效评价。结论多种检测平台和检测方法的应用,对rh EPO在临床研究和上市后的免疫原性评价或PRCA的监测具有重要意义。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 collab- orative study involving three different laboratories and different assay platforms was carried out. Direct ELISA was used to test the affin- ities 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 la- boratories. 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.

关 键 词：抗人EPO抗体 直接ELISA 间接ELISA 中和性抗体 CUT off值 

分 类 号：R915[医药卫生—微生物与生化药学]