目的 研究国产细胞培养用球状微载体应用于肠道病毒71型(enterovirus 71,EV71)灭活疫苗生产的可行性。方法 将进口与国产2种微载体置于40 L反应器中培养Vero细胞并接种EV71,对比2种微载体的细胞贴壁效率、细胞生长状况、培养病毒的抗原含量及病毒滴度的差异。结果 在40 L反应器培养阶段,2种微载体中细胞密度(t=1.05,P=0.354)、细胞的贴壁效率(t=1.65,P=0.173)以及种毒后96 h病毒滴度(t=0.39,P=0.732)间差异均无统计学意义。在120 h时,国产微载体上的细胞数量为进口微载体的90.11%。种毒后96 h,国产微载体的抗原含量为进口微载体的89.41%。结论 综合对比结果及制造、运输成本,国产微载体具有应用于EV71灭活疫苗生产的可行性。
张豆
,
郭长福
,
明平刚
,
解庭波
,
喻刚
,
乔建
,
陈金华
,
张义峰
,
宰家敏
,
陈筱亚
,
任彬
,
李月影
,
胡超
,
唐革
,
谷怿恒
,
袁波
,
陈晓琦
. 国产球状微载体在肠道病毒71型疫苗培养中的应用[J]. 国际生物制品学杂志, 2024
, 47(1)
: 11
-14
.
DOI: 10.3760/cma.j.cn311962-20230116-00008
Objective To study the feasibility of utilizing domestic spherical microcarriers for cell culture in the production of enterovirus 71 (EV71) inactivated vaccine. Methods Vero cells were cultured in 40 L reactor with 2 types of microcarriers, one domestically manufactured and the other imported, and EV71 was inoculated with cells afterwards. The two microcarriers were compared in terms of cell adhesion efficiency, cell growth status, cultivated virus antigen content, and viral titers. Results During the 40 L reactor culture phase, no statistically significant difference was observed in cell density(t=1.05, P=0.354), cell adhesion efficiency (t=1.65, P=0.173) or viral titer 96 h post-inoculation(t=0.39, P=0.732) in 2 microcarriers. At 120 h, the cell count in domestic microcarriers was 90.11% of that in imported microcarriers. At 96 h post-inoculation, the antigen content in domestic microcarriers was 89.41% of that in imported microcarriers. Conclusion In view of the comparison result and the cost of manufacturing and transportation, the domestic microcarrier can be used in the production of EV71 inactivated vaccine.