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

Author:

Khan Imran1,Rahman K. M. Taufiqur1,Siraj S. M. Saad Us1,Karim Mahbubul1,Muktadir Abdul1,Maheshwari Arpan1,Kabir Md Azizul1,Nahar Zebun1,Ahasan Mohammad Mainul1ORCID

Affiliation:

1. Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh

Abstract

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 be0.26±0.16,0.21±0.11,0.21±0.11, and0.14±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.

Publisher

Hindawi Limited

Subject

Analytical Chemistry

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