【摘要】 本研究应用摆床反应器搭配一次性载体反应袋实现了无血清Vero细胞的高密度培养，同时研究了接毒时的细胞密度、病毒感染复数（Multiplicity of Infection,MOI）等参数对病毒收获液的狂犬病毒滴度和抗原含量的影响。结果发现，最适培养条件参数为在细胞密度培养为（6.0±0.3）×10~6 cells/mL时，按照MOI值为0.01进行接毒，且重复性验证结果符合预期，同时其制备的原液与传统工艺相比，在抗原含量、效价上无统计学差异；宿主细胞DNA(Host Cell DNA,HCD)残留、宿主细胞蛋白（Host Cell Protein,HCP）残留、牛血清白蛋白（Bovine Serum Albumin,BSA）残留显著优于传统工艺。更多还原

【Abstract】 In this study, a rocking bed reactor combined with disposable carrier reaction bags is applied to achieve the entire production process of high-density culture of serum-free Vero cells. Meanwhile, the effects of parameters such as cell density and virus Multiplicity of Infection(MOI) at the time of virus inoculation on the rabies virus titer and antigen content of the virus harvesting medium were investigated. The optimal culture condition parameters for toxin inoculation based on a MOI value of 0.01 were obtained when the cell density was cultured to(6.0±0.3)×10~6 cells/mL. And the repeatability verification results meet expectations. At the same time, there was no statistically significant difference in antigen content and potency between the prepared raw liquid of SFM process and traditional process. The residual of Host Cell DNA(HCD), Host Cell Protein(HCP) and Bovine Serum Albumin(BSA) are significantly better than traditional processes.更多还原