公开(公告)号：US20220137051A1

公开(公告)日：2022-05-05

申请号：US17531314

申请日：2021-11-19

Applicant: GLAXOSMITHKLINE BIOLOGICALS SA

Inventor： Marzia Monica GIULIANI ,  Elena MORI

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

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：US20200319184A1

公开(公告)日：2020-10-08

申请号：US16799113

申请日：2020-02-24

Applicant: GLAXOSMITHKLINE BIOLOGICALS SA

Inventor： Marzia GIULIANI ,  Elena MORI

IPC: G01N33/577 ,  C07K16/12 ,  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.