血凝素(流感)
流感疫苗
病毒学
化学
抗原
病毒
色谱法
接种疫苗
效力
拉伤
甲型流感病毒
正粘病毒科
免疫分析
微生物学
抗体
生物
体外
免疫学
生物化学
解剖
作者
Barry Lorbetskie,Nathalie Fortin,Laura Durno,Junzhi Wang,Changgui Li,Xuguang Li,Michel Girard,Simon Sauvé
标识
DOI:10.1016/j.chroma.2017.10.041
摘要
Seasonal inactivated quadrivalent influenza vaccines are currently formulated to include antigens from two strains of influenza A and a strain from each of the two circulating influenza B virus lineages. However, the applicability of the potency assay currently required for the release of vaccines has been hindered due to cross-reactivity between the two B strains. In this study, a reversed-phase high-performance liquid chromatography method previously developed for the separation and quantitative determination of the hemagglutinin content in trivalent influenza vaccine preparations was further extended and found to be adaptable for the assessment of all four hemagglutinin antigens present in quadrivalent influenza vaccines. Vaccines prepared from monovalent bulks and commercial quadrivalent products from the past three vaccination seasons in the Northern Hemisphere were tested with the new method. The results showed excellent resolution of all four hemagglutinins from frequently interfering formulation agents such as surfactants. This method provides a simple approach for fast evaluation of quality and hemagglutinin strain identification in influenza vaccines. It is also the only physicochemical method capable of distinguishing the B strains in quadrivalent influenza vaccines.
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