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Qualification of a quantitative stability indicating potency assay for mRNA-LNP vaccine candidates [version 1; peer review: awaiting peer review]

Potency assays assess the functional integrity of a target antigen to ensure that the final drug product is consistent between the commercial and clinical trial lots. Existing mRNA-LNP vaccine potency assays require complex quantification methods, such as flow cytometry, which are not widely adaptab...

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Autors principals: ANAN BZAMI, Tim Schofield, Marcus Estrada, Jessica A. White
Format: Artigo
Idioma:Inglês
Publicat: F1000 Research Ltd 2026-05-01
Col·lecció:Gates Open Research
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Accés en línia:https://gatesopenresearch.org/articles/10-26/v1
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