摘要
目的比较细胞工厂培养箱及普通培养箱用于生产水痘疫苗的差异。方法对两种培养箱进行温度测试。比较两种培养箱内培养人胚肺成纤维MRC-5细胞的生长情况及活细胞数量,并对制备出的相应水痘疫苗原液进行无菌检查及病毒滴度测定。结果与普通培养箱比较,细胞工厂培养箱的温度更稳定;培养MRC-5细胞的贴壁范围更大,活细胞数更高,且批内及批间的均一性更好;其制备水痘疫苗原液的病毒滴度略高,批内及批间的均一性更好,且无菌检查均合格。结论应用细胞工厂培养箱制备水痘疫苗,可提高疫苗的批间均一性,降低人工劳动强度及污染风险,适用于大规模疫苗生产。
Objective To compare the differences between cell factory incubator and common incubator for the production of varicella vaccine.Methods The temperatures of two incubators were determined.The growths and live cell counts of MRC-5 cells cultured in the two incubators were compared,and the prepared bulks of varicella vaccine were tested for sterility and determined for virus titer.Results The temperature of cell factory incubator was more stable than that of common incubator.The area of adherent cells and live cell count in cell factory incubator were larger than those in common incubator,which showed good consistencies in the same batch and between various batches.Both the cells cultured in two incubators were qualified in sterility test.Conclusion The preparation of varicella vaccine by using cell factory incubator increased the consistency of vaccine of various batches and reduced the labor intensity,which was suitable for large scale production.
出处
《中国生物制品学杂志》
CAS
CSCD
2017年第5期455-458,共4页
Chinese Journal of Biologicals
