Lorbetskie Barry, Fortin Nathalie, Durno Laura, Wang Junzhi, Li Changgui, Li Xuguang, Girard Michel, Sauvé Simon
Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, 251 Sir Frederick Banting, Tunney's Pasture, Ottawa, Ontario, K1A 0K9, Canada.
National Institutes for Food and Drug Control and WHO Collaborating Center for Standardization and Evaluation of Biologicals, National Institute for Food and Drug Control of China, No.2 Tiantan Xili, Beijing, 10050, China.
J Chromatogr A. 2017 Dec 15;1528:18-24. doi: 10.1016/j.chroma.2017.10.041. Epub 2017 Oct 18.
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.
