【摘要】 目的 对治疗用抗HFRS病毒单克隆抗体三批中试产品进行全面的检定。方法 参照国家食品药品监督管理局颁布的《人用鼠源性单克隆抗体质量控制要点》进行各项检定。结果 所有检定项目均合格，其中单抗蛋白纯度>95%，单抗IgG单体纯度>95%,残余骨髓瘤细胞(SP2/0)DNA含量<100pg/剂量，微量细胞培养中和试验法检测抗体中和效价>1:12800～1:25600，鼠源性病毒检测、支原体检测、无菌试验、安全试验、热原质试验均合格。在自检合格的基础上，送中国药品生物制品检定所检定合格。结论 抗HFRS病毒单克隆抗体三批中试产品符合临床研究的质量要求。

    【关键词】 质量控制； 单克隆抗体； 肾综合征出血热

    Quality control of monoclonal antibody against HFRS virus for therapeutic application

    ZOU Chang-yong,MIAO Yan-min, LEI Ji-jun，et al.Wuhan Institute of Biological Products,Wuhan 430060，China

    【Abstract】 Objective To analyze the quality of prepared three lot products of monoclonal antibody(mAb) against hemorrhagic fever with renal syndrome(HFRS) virus. Methods The overall quality control was performed according to the standardization on preparation and inspection of murine mAb for therapeutic application which was issued by SFDA in 1999.Results All inspected items were qualified, the protein purity of IgG were above 95%,the neutrilizing titer of mAb varied from 1:12800 to 1:25600,no murine viruses contaminations were detected,and residual DNA was lower than 100pg/dose.Conclusion The results proved that the prepared mAb are qualified for application in clinic trial. ......