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    • 6. 发明公开
    • IN VITRO POTENCY ASSAY FOR PROTEIN-BASED MENINGOCOCCAL VACCINES
    • 血管内皮生长因子
    • EP2823312A2
    • 2015-01-14
    • EP13710328.9
    • 2013-03-08
    • Novartis AG
    • GIULIANI, MarziaMORI, Elena
    • G01N33/569G01N33/577C12N15/03
    • G01N33/577C07K16/1217C07K2317/33C07K2317/56G01N33/56911G01N2333/22
    • 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.
    • 本发明使用ELISA或类似的测定来分析脑膜炎球菌疫苗。 该测定使用与疫苗内的脑膜炎球菌蛋白结合的抗体,特别是对脑膜炎球菌具有杀菌性和/或识别脑膜炎球菌蛋白质内的构象表位的单克隆抗体。 通过对测试疫苗的一系列稀释液进行测定,并且通过将结果与使用已知效价的参考疫苗获得的结果进行比较,可以确定测试疫苗的相对效价。 该值可以用作确定制造的疫苗批次是否适合向公众释放的参数,或者是否已经经历生产故障,因此不应该使用。