VITRO POTENCY ASSAY FOR PROTEIN-BASED MENINGOCOCCAL VACCINES

    公开(公告)号:US20200319184A1

    公开(公告)日:2020-10-08

    申请号:US16799113

    申请日:2020-02-24

    Abstract: The invention uses Elisa or similar assays for analysing a meningococcal vaccine. The assay uses antibodies which bind to meningococcal proteins within the vaccine, and in particular monoclonal antibodies which are bactericidal for meningococcus and/or which recognise conformational epitopes within the meningococcal proteins. By performing the assay on a series of dilutions of a test vaccine, and by comparing the results with those obtained using a reference vaccine of known potency, it is possible to determine the relative potency of the test vaccine. This value can be used as a parameter for determining whether a manufactured batch of a vaccine is suitable for release to the public, or whether it has experienced a production failure and so should not be used.

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