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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。
After the recovery of JEV-McAb primary cell line 2H4 and 2F2, the cells were passaged in vitro for 6 months when the positive rate of clonality was 100%. The stability of secreted antibody was observed and the survival rate of frozen-storage 0 , 1, 4, 7 years of cell resuscitation, ascites was routinely prepared for antibody-specific assays for ELISA, neutralization, hemagglutination inhibition and in vivo protection assays. As a result, the cells continued to stably secrete specific antibodies 6 months after passage, and the antibody titers of the culture supernatants and ascites fluid did not decrease. Antibody specificity remained unchanged after 0-7 cell cryopreservation. Mycoplasma and murine virus were negative, and 16 kinds of human tissues do not cross-react. Show that the original cell bank and production cell bank stability and specificity are in line with quality control requirements.