A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine.
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.
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
Imran
I
Khan
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
K M Taufiqur
KM
Rahman
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
S M Saad Us
SM
Siraj
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
Mahbubul
M
Karim
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
Abdul
A
Muktadir
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
Arpan
A
Maheshwari
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
Md Azizul
MA
Kabir
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
Zebun
Z
Nahar
Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, Bangladesh.
Mohammad Mainul
0000-0002-8268-2206
MM
Ahasan
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