建立肾综合征出血热双价纯化疫苗人用疫苗生产传代细胞系Vero细胞库的研究

The study in the course of establishing Vero cell bank for production

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

Objective To establish cell bank(PCB,MCB,WCB) used for production of HFRS bivalent vaccine,and secure safety of Vero cells as substrates of virus cultivation.Methods A series of tests including karyotypic analysis test and neoplasia test etc.were made according to<the Chinese regulations for biologics production>(2002 edition). Results Vero cells stored at my institute were not contaminated with any bacteria,its neoplasia test reached to the requirements,all its biologic qualities remained.. Conclusions Vero cells stored at my institute(NO.128 generation)can be used as original cell bank producing purified HFRS bivalent vaccine.