A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine

الملخص EN

Molecular size distribution of meningococcal polysaccharide vaccine is a readily identifiable parameter that directly correlates with the immunogenicity.

In this paper, we report a size exclusion chromatography method to determine the molecular size distribution and distribution coefficient value of meningococcal polysaccharide serogroups A, C, W, and Y in meningococcal polysaccharide (ACWY) vaccines.

The analyses were performed on a XK16/70 column packed with sepharose CL-4B with six different batches of Ingovax® ACWY, a meningococcal polysaccharide vaccine produced by Incepta Vaccine Ltd., Bangladesh.

A quantitative rocket immunoelectrophoresis assay was employed to determine the polysaccharide contents of each serogroup.

The calculated distribution coefficient values of serogroups A, C, W, and Y were found to be 0.26 ± 0.16 , 0.21 ± 0.11 , 0.21 ± 0.11 , and 0.14 ± 0.12 , respectively, and met the requirements of British Pharmacopeia.

The method was proved to be robust for determining the distribution coefficient values which is an obligatory requirement for vaccine lot release.