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- W4323656080 abstract "This report describes an application of analytical high performance size exclusion chromatography with UV and Fluorescent detection (HPSEC-UV/FLR) method that enabled a bridging from research vaccine candidate discovery (His-tagged model) to clinical product development (Non-His-tagged molecules). HPSEC measurement can accurately determine the total trimer-to-pentamer molar ratio by either titration evaluation during the nanoparticle being assembled or dissociation during a well-formed nanoparticle being dis-assembled. Through experimental design with small sample consumptions, HPSEC can provide a quick determination on the nanoparticle assembling efficiency which can therefore guide the buffer optimization for an assembly, from His-tagged model nanoparticle, to non-His-tagged clinical development product. HPSEC has also discovered a difference in assembling efficiencies for various strains of HAx-dn5B with Pentamer-dn5A components, and different efficiencies for monovalent assembly vs. multivalent assembly. The present study demonstrates HPSEC as a pivotal tool to support the Flu Mosaic nanoparticle vaccine development from research to clinical production." @default.
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- W4323656080 date "2023-04-01" @default.
- W4323656080 modified "2023-10-18" @default.
- W4323656080 title "Characterization of Flu MOSAIC nanoparticle vaccine candidate using high performance size-exclusion chromatography to support vaccine process development" @default.
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- W4323656080 doi "https://doi.org/10.1016/j.vaccine.2023.03.001" @default.
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