水痘减毒活疫苗生产工艺研究

Research of production process of live attenuated varicella vaccine

目的:比较细胞工厂和方瓶两种培养方式所生产水痘疫苗的产量及质量。方法:使用细胞工厂和方瓶培养2BS细胞,长成致密单层后接种水痘-带状疱疹病毒OKa株,待细胞病变达70%以上时,用EDTA消化、洗涤离心收集病变细胞,加入保护剂-65℃以下保存,检定合格后进行超声、澄清制备原液和半成品,转分装冻干制成。结果:使用细胞工厂和方瓶获得的水痘疫苗原液及成品的各项检定结果均符合本企业《水痘减毒活疫苗注册标准》的要求。结论:细胞工厂大大减少了厂房占用面积,提高了疫苗产量,保证了疫苗生产过程的质量可控性和稳定性,适用于水痘疫苗的规模化生产。

Objective： To compare the yield and quality of live attenuated varicella vaccine produced with flask and advanced Cell-Stack. Methods： 2BS cell were cultivated in 4-layer or 10-layer Cell-Stack and flask, inoculated with VZV Oka strain when it grows into thick monolayer, digested by EDTA and collect pathological cell by dilution and centrifugation when lesion rate reached over 70% , then add protective agent and store under -65 ℃. When it is tested to be qualified, prepare stock solution and semi-finished product by sonication and clarification. Finally transfer to filling and packaging workshop to freeze-dry it. Results： Test results of stock solution and final product produced with Cell-Stack and flask consisted with the requirement of Registration Standard of Live At- tenuated Varicella Vaccine. Conclusion： Cell-Stack cultivation method significantly decreased the factory area, increased vaccine＇s yield, ensured the controllability and stability of vaccine＇s quality, which is suitable for large scale production of live attenuated varicella vaccine.