The main role of our group is to evaluate the quality of saccharide-protein conjugate components and bacterial protein antigens in licensed or late-stage development vaccines.
We evaluate these indicators of a vaccine’s quality:
Our Analytical Sciences and Biotherapeutics divisions and lead product laboratories in Bacteriology evaluate other aspects such as safety and immunogenicity.
Our laboratory assses a range of standards and reference materials listed here:HibMeningococcalTyphoid
We are currently evaluating candidate international standards for MenA and MenX, and the 2nd Hib international standard.
The control tests we carry out are:
Our laboratory provides support to evaluate the stability of trial-fills and definitive-fills of polysaccharide International Standards established for the quantitative determination of Hib and meningococcal saccharide content – or potency – in vaccines.
We take part in collaborative studies to assign unitage and to determine how the standard will perform in real situations. This is often of mutual benefit to the relevant World Health Organisation (WHO)-sponsored project and the individuals taking part.
We test Hib and meningococcal conjugate vaccines to the requirements of WHO and Official Medicines Control Laboratories guidelines for formal batch release of licensed products for European and non-European countries, and for WHO prequalification and monitoring.
We also carry out contract or collaborative evaluation of new products – frequently for global markets. This is often to enable quality comparisons through different approaches and to explore the strengths and limitations of particular methods used for characterisation or control.
We use circular dichroism and fluorescence spectroscopy to evaluate the secondary and tertiary structure of proteins, while we use sizing chromatography linked to a light scattering detector (SEC-MALLS) to more accurately gauge the quaternary structure and aggregation status of vaccine materials in stability studies.
As well as analysing the protein components, saccharide and lipid components are evaluated with ion-exchange and reverse-phase chromatography.
Micro-flow imaging particle analysis (> 1 µm) adds a further dimension to formulation studies. One of our long-term goals is to achieve a better understanding of the molecular basis of immunoprotection.
Barbara Bolgiano, Group LeaderNicola Beresford, Deputy Group Leader, Quality Control ManagerFang Gao, Deputy Group Leader, Laboratory Manager
08/214: WHO 1st International Standard for Meningococcal Serogroup C polysaccharide