应用生物反应器建立人用冻干狂犬病疫苗(Vero细胞)生产工艺的研究

应用15L生物反应器,采用片状载体对Vero细胞进行高密度培养、制备高毒力滴度的狂犬病毒收获液,经纯化后生产人用冻干狂犬病疫苗。采用15L生物反应器对培养方法(批次培养和连续灌流培养)进行试验,收获高毒力滴度的狂犬病毒收获液并制备人用冻干狂犬病疫苗。结果表明:Vero细胞在接种狂犬病毒后可以连续收获病毒液达到25d以上,冻干狂犬病疫苗的效价可以达到5.54IU/剂。本工艺可以用于进行大规模的人用冻干狂犬疫苗的生产。

Bioreactor Application to Establish Production Technology of Freeze-Dried Rabies Vaccine (Vero Cells ) for Human Use

15 L bioreactor was applied adopting chip carrier to carry out high density cultivation of Vero cells and prepare high titer rabies virus harvested in liquid and produce freeze-dried rabies vaccine for human use after purification.Rabies virus was first cultured adopting 15 L bioreactor by batch culture and continuous flow culture as a trial of cultivation method,and the culture procedure was optimized,based on which high titer rabies virus liquid was harvested to prepare freeze-dried rabies vaccine for hum...