体内治疗用鼠源性乙脑单克隆抗体细胞系的质量控制  

Quality Control of Murine Therapeutic Japanese Encephalitis McAb Cell Strain

作　　者：肖毅[1] 马文煜[1] 黄庆生[1] 刘利兵[1] 任君萍[1] 陈海威 过琴媛[2] 张碧如[2] 黄浩[2] 尹红章[3] 

机构地区：[1]第四军医大学,西安710032 [2]卫生部北京生物制品研究所,北京100024 [3]中国药品生物制品检定所,北京100050

出　　处：《中国生物制品学杂志》1998年第4期223-226,共4页Chinese Journal of Biologicals

基　　金：国家"85"重点科技项目!85.7222-18-01

摘　　要：分泌乙脑单克隆抗体（JEV－McAb）原始细胞株2H4、2F2复苏后，在克隆化阳性率达100％时，细胞体外长期传代6个月，观察分泌抗体的稳定性，并对冻存0、1、4、7年的细胞复苏，按常规制备腹水，作ELISA、中和、血凝抑制和体内保护试验进行抗体特异性检定。结果，细胞传代6个月仍能持续稳定分泌特异性抗体，培养上清和腹水抗体效价不降低。冻存0～7年细胞复苏后抗体特异性不变。支原体及鼠源性病毒检测均为阴性，与人体16种组织不发生交叉反应。表明原始细胞库及生产细胞库其稳定性与特异性均符合质控要求。Two primary murine hybridoma cell strains (2H. and 2F2) secreting McAbsto Japanese encephalitis (JE) were resuscitated and cloned. After the cloning positive ratereached 100%, the 2 strains were passaged for 6 months, and the antibody secretingstabilities of them were studied. In addition, the cell strains were resuscitated after being freezedfor 0, 1, 4 and 7 years and used for preparing murine ascites. The specificities of the McAbsin the ascites were detected by ELISA neutralization test, hemogglutination inhibition testand in vivo protection test. The result showed that the cell strains could still secrete specificMcAb stably after being passaged for 6 months, and the titers of McAbs in culturesupernatant and murine ascites were not decreased. No change was observed in the specificities ofMcAbs secreted by the cell strains freezed for 0~7 years. Neither mycoplasma nor murinevirus was detected out in the cell strains. No cross reaction was found among the cell strainsand 16 kinds of human tissue. It indicated that both the stabilities and specificities of primaryand passaged cell strains met the requirements for quality control.

关 键 词：细胞系 质量控制 McAb 

分 类 号：TQ464[化学工程—制药化工] Q78[生物学—分子生物学]