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目的 建立HFRS双价纯化疫苗生产用三级细胞库 ,确保Vero细胞作为病毒培养基质的安全性。方法 以 2 0 0 2年版《中国生物制品规程》对生物制品生产用传代细胞系的要求 ,对Vero细胞进行核型分析、致肿瘤性等一系列基础性试验。结果 该生物所保存的Vero细胞未污染细菌、支原体 ,致肿瘤试验符合2 0 0 2年版《中国生物制品规程》要求 ,染色体核型分析结果为保持有原细胞学核学特征。结论 该所保存的Vero细胞 1 2 8代可以作为HFRS双化纯化疫苗生产的原始细胞库细胞
Objective To establish a tertiary cell bank for the production of HFRS bivalent purified vaccine and to ensure the safety of Vero cells as a substrate for virus culture. Methods A series of basic tests such as karyotype analysis and neoplasia on Vero cells were carried out with the requirements of the 2002 China Biological Products Regulation on the subcultured cell lines for biological products. Results The Vero cells stored in this organism were not contaminated by bacteria, Mycoplasma, tumor-causing test in line with the requirements of the 2002 edition of the “China Biological Products Regulation”. The result of chromosome karyotype analysis was to maintain the original cytology and nuclear characteristics. Conclusion The Vero cells stored in the 128 generation can be used as HFRS double -purified vaccine production of primitive cell bank cells