公开(公告)号：US11209436B2

公开(公告)日：2021-12-28

申请号：US16799113

申请日：2020-02-24

Applicant: GLAXOSMITHKLINE BIOLOGICALS SA

Inventor： Marzia Giuliani ,  Elena Mori

IPC: A61K39/095 ,  C07K14/22 ,  C07K16/12 ,  G01N33/577 ,  G01N33/569

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.

公开(公告)号：US10598666B2

公开(公告)日：2020-03-24

申请号：US14382690

申请日：2013-03-08

Applicant: GlaxoSmithKline Biologicals SA

Inventor： Marzia Giuliani ,  Elena Mori

IPC: C07K16/12 ,  G01N33/577 ,  A61K39/095 ,  G01N33/569

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.