IN-VITRO POTENCY ASSAY FOR PROTEIN-BASED MENINGOCOCCAL VACCINES

    公开(公告)号:US20220137051A1

    公开(公告)日:2022-05-05

    申请号:US17531314

    申请日:2021-11-19

    摘要: 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.