自动化溶液配制输送系统在水痘疫苗生产中的应用

Application of Automatic System for the Preparation and Delivery of Sterile Solutions in Varicella Vaccine Production

目的:应用自动化系统配制输送用于生产水痘疫苗的无菌溶液,以满足水痘疫苗细胞工厂的规模化量产需求,减少批间差异。方法:将采用自动化系统配制输送用于水痘疫苗的传代制备所需溶液,与人工操作方式进行对照,比较两种操作方式的细胞生长情况、操作时间等,并对制备的疫苗原液进行相关检定。结果:在同样细胞复苏量的情况下,采用自动化操作系统比人工操作生产的水痘疫苗批间差异小,操作时间短,且相关检测指标均合格。结论:利用自动化溶液配制输送系统制备用于生产水痘疫苗的无菌溶液,提高了批间均一性,降低人工劳动强度,缩短操作时间,减少转运等中间环节,降低污染风险,可满足水痘疫苗细胞工厂的大规模生产。

Objective: Application of automatic system for the preparation and delivery of sterile solutions in varicella vaccine production meets the demand of scale production of varicella vaccine by use of cell factory. And it reduces differences between batches. Methods: The solutions for varicella vaccine passage are prepared by automatic system or manual operation mode. It is compared in cell growth, operating time, and product test of the two modes. Results: In the case of the same amount of cell recovery, almost no differences between the varicella vaccine production batches can be found, and it takes shorter operation time in use of automatic operation system than the manual operation mode. And the detection of indicators is qualified. Conclusion: The use of automatic system to prepare and deliver sterile solutions in varicella vaccine production can improve the homogeneity between vaccine batches, reduce labor intensity, shorten operation time, reduce transportation and other intermediate links, and decline the risk of contamination, which is able to meet the requirements for varicella vaccine cell factory scale production.