10 L转瓶培养与10层细胞工厂培养制备麻疹单次病毒收获液的比较

Comparison of 10 L Spinner Bottle Cell Culture and 10 Layer Cell Factory Cell Culture in Preparing Measles Virus Single Harvest Fluid

目的:对10 L转瓶培养与10层细胞工厂培养制备麻疹单次病毒收获液进行比较,评价两种生产工艺的优劣。方法:将10 L转瓶培养与10层细胞工厂培养制备麻疹单次病毒收获液的每一步进行比较,通过关键质量指标的病毒滴度来对其生产工艺进行评价。结果:10 L转瓶培养和10层细胞工厂培养制备麻疹单次病毒收获液的病毒滴度分别为5.6 lgCCID50/mL、5.6 lgCCID50/mL。结论:10 L转瓶培养工艺和10层细胞工厂培养工艺均可以制备麻疹单次病毒收获液,二者没有显著性差异。

Objective: The objective is to compare the advantages and shortages between 10 L spinner bottle cell culture and 10 layer cell factory cell culture in preparing measles virus single harvest fluid process. Methods: In each step, the two processes were assessed by viral titer, a Critical Quality Attribute (CQA) in measles virus harvest production. Results: The viral titer results of 10 L spinner bottle cell culture process and 10 layer cell factory cell culture process are 5.6 lgCCID50/mL and 5.6 lgCCID50/mL respectively. Conclusion: The measles virus single harvest fluid could be prepared by both spinner bottle cell culture and 10 layer cell factory cell culture, but there was no significant difference between them.