Investigation into alternative testing methodologies for characterization of influenza virus vaccine

摘要: The objective of this study was to explore various testing methodologies suitable for characterizing sedimented or agglomerated material. To model this, bioCSL's split influenza virus vaccine, Fluvax® utilized. investigation conducted on 5 dispensed lots commercially manufactured formulated the 2013 Southern Hemisphere season. Vaccine syringes were initially inspected by visual tests; material then aseptically pooled characterization assessment microscopy and several agglomeration assays. All passed description test where any fine large sized particles sediment observed in vaccine resuspended upon shaking; inverted light verified that morphology consistent with vaccine. Electron microscopic examination demonstrated presence typical structures including virus, virosomes, whole agglomerates. An optical density turbidity assay revealed relatively high protein recoveries supernatant post-centrifugation treatment, thus indicative a well-dispersed formulation. This corroborated particle sizing analysis using dynamic scattering which generated reproducible volume size distributions polydisperse nature. Ultraviolet-visible absorbance profiles further confirmed some Data from all methods results between batches Therefore, suitability usefulness appearance It is suggested such may be applicable beneficial development wider spectrum heterogeneous formulations provide safe, efficacious superior quality biopharmaceutical products.