Glaxosmithkline Biologicals Sa

Novartis Ag

Elena Mori

Marzia Monica Giuliani

John J Donnelly

Cristiana Balocchi

Marilena Paludi

Enrico Luzzi

John Donnelly

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.

Vitro potency assay for protein-based meningococcal vaccines

In vitro potency assay for protein-based meningococcal vaccines

The disclosure provides compositions, methods and kits for assessing immunogenicity, potency, or both, of meningococcal capsular saccharide vaccines. The assessment is based upon measurement of binding of a bactericidal antibody to a capsular saccharide component in the vaccine.

Bactericidal antibody assays to assess immunogenicity and potency of meningococcal capsular saccharide vaccines

Growing community of inventors

Monteriggioni, Italy

Elena Mori