水痘疫苗原液生产工艺改进

目的: 对现有水痘减毒活疫苗原液生产工艺进行改进,提高水痘疫苗原液产量及疫苗质量。方法: 2BS细胞传代至方瓶37代细胞,感染Oka株水痘-带状疱疹病毒工作种子批,35℃培养24h换病毒培养液(II)继续置35℃培养24h,取出使用Earle’s液洗涤方瓶细胞表面,当细胞病变达70%以上时,按120-360ml/瓶进行收获,置-65℃以下保存。经检定合格后进行合并、冻干制备水痘减毒活疫苗。结果: 使用此方法进行生产的水痘疫苗比较原工艺生产的水痘疫苗原液收获量大幅提升,并且疫苗的牛血清残留量与抗生素残留量则大幅下降,且各项检定指标全部合格。结论: 使用此方法生产水痘疫苗产量及质量比较原工艺有大幅度提升。

Objective: Live attenuated varicella vaccine to the existing stock solution production process improvements to enhance the quantity and quality of the vaccine Methods: 2BS cells were cultivated and passaged to the generation of 37, inoculated with VZV Oka strain when it grows into thick monolayer,Cultured under the conditions at 35 ℃ for 24 hours and then replaced the virus culture medium.(II)Continue to be placed under the conditions of 35 ℃ for24 hours,Then washed the cell surface with Earle's solution. when lesion rate reached over 70%, add 120-360ml protective agent each flask,and then placed under-65℃.When it is tested to be qualified,combined and freeze-dry it.Results: Compared with the original production process,using this method is more effective.the stock solution of vaccine increased dramatically.Also,the vaccine and antibiotic residues in bovine serum residual volume significantly decreased,and all the test indicators qualified.Conclusion:This method of varicella vaccine production has improved yield and quality significantly than the original process.