In Japan, the practical application of completely cell-based seasonal influenza vaccines is under consideration. Considering the good correlation between the immunogenicity of egg-based influenza vaccines and the hemagglutinin (HA) content determined by the single radial immunodiffusion (SRD) assay, we determined the potency of the first cell-based quadrivalent vaccine experimentally generated in Japan using the SRD assay in this study. A primary liquid standard (PLS) and reference antigen were generated from the purified vaccine virus, and a sheep antiserum was produced against the HA of the vaccine virus. Since the purity of the PLS affects the reliability of vaccine potency testing, the purification steps are significant. We successfully prepared a purified PLS nearly free of cell debris. The HA content in the PLS was first estimated from the total amount of viral protein and the percentage of HA content determined by SDS-PAGE analysis. The HA content in the reference antigen was calibrated to that in the PLS via the SRD assay. The vaccine potency, that is, the HA content in each vaccine, was finally measured using the corresponding reference antigen. Ultimately, the measured vaccine potency of the monovalent vaccine was similar to that of the quadrivalent vaccine.

在日本，完全基于细胞的季节性流感疫苗的实际应用正在考虑中。考虑到鸡蛋流感疫苗的免疫原性与单径向免疫扩散 (SRD) 测定确定的血凝素 (HA) 含量之间的良好相关性，我们确定了日本使用 SRD 实验产生的第一种基于细胞的四价疫苗的效力本研究中的测定。从纯化的疫苗病毒中产生初级液体标准品 (PLS) 和参考抗原，并产生针对疫苗病毒 HA 的绵羊抗血清。由于 PLS 的纯度会影响疫苗效力测试的可靠性，因此纯化步骤非常重要。我们成功制备了几乎不含细胞碎片的纯化 PLS。PLS 中的 HA 含量首先从病毒蛋白的总量和通过 SDS-PAGE 分析确定的 HA 含量百分比来估计。参考抗原中的 HA 含量通过 SRD 测定校准到 PLS 中的含量。最终使用相应的参考抗原测量疫苗效力，即每种疫苗中的 HA 含量。最终，测得的单价疫苗的疫苗效力与四价疫苗的相似。