冻干水痘减毒活疫苗转瓶生产工艺的建立

Establishment of the production process of freeze-dried live attenuated varicella vaccine with roller bottle

应用旋转培养的方法 ,建立冻干水痘减毒活疫苗的生产工艺。选择长成致密单层的 2BS细胞 ,接种带状疱疹病毒Oka株 ,待细胞病变达 75%以上时 ,收获病毒液 ,经超声破碎、离心、澄清 ,冻干后 ,按常规检定 ,疫苗各项检定符合《WHO水痘活疫苗规程》及《冻干水痘减毒活疫苗制造及检定试行规程》要求。与克氏瓶相比 ,应用旋转培养 ,不但提高了疫苗单产 ,降低了牛血清蛋白残留量 。

The production process was established for preparing freeze-dr ied attenuated varicella vaccine with roller bottle.The Oka-varicella-zoster virus was inoculates in a dense 2BS cells monolayer.The virus suspension was harvestesd when cytopathic effect(CPE)was above 75%. The general detection was carried out after the virus suspension was ultrasonic disrupted, centrifuged,clarified and freeze-dried.The detection results were in accordance with the WHO requirements for vericella vaccine and freeze-dried live attenuated varicella vaccine.It suggested that the production and quality of vaccine were increased,the residual bovine serum decreased by roller bottle method than those with the claisen flask do.