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...

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Main Authors: Imran Khan, K. M. Taufiqur Rahman, S. M. Saad Us Siraj, Mahbubul Karim, Abdul Muktadir, Arpan Maheshwari, Md Azizul Kabir, Zebun Nahar, Mohammad Mainul Ahasan
Format: Article
Language:English
Published: Wiley 2016-01-01
Series:International Journal of Analytical Chemistry
Online Access:http://dx.doi.org/10.1155/2016/9404068
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author Imran Khan
K. M. Taufiqur Rahman
S. M. Saad Us Siraj
Mahbubul Karim
Abdul Muktadir
Arpan Maheshwari
Md Azizul Kabir
Zebun Nahar
Mohammad Mainul Ahasan
author_facet Imran Khan
K. M. Taufiqur Rahman
S. M. Saad Us Siraj
Mahbubul Karim
Abdul Muktadir
Arpan Maheshwari
Md Azizul Kabir
Zebun Nahar
Mohammad Mainul Ahasan
author_sort Imran Khan
collection DOAJ
description 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.
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institution Kabale University
issn 1687-8760
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language English
publishDate 2016-01-01
publisher Wiley
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series International Journal of Analytical Chemistry
spelling doaj-art-a0adafc5dad1450a859ef99e9792f17b2025-02-03T01:02:11ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792016-01-01201610.1155/2016/94040689404068A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide VaccineImran Khan0K. M. Taufiqur Rahman1S. M. Saad Us Siraj2Mahbubul Karim3Abdul Muktadir4Arpan Maheshwari5Md Azizul Kabir6Zebun Nahar7Mohammad Mainul Ahasan8Incepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshIncepta Vaccine Ltd., Zirabo, Savar, Dhaka 1341, BangladeshMolecular 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.http://dx.doi.org/10.1155/2016/9404068
spellingShingle Imran Khan
K. M. Taufiqur Rahman
S. M. Saad Us Siraj
Mahbubul Karim
Abdul Muktadir
Arpan Maheshwari
Md Azizul Kabir
Zebun Nahar
Mohammad Mainul Ahasan
A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine
International Journal of Analytical Chemistry
title A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine
title_full A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine
title_fullStr A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine
title_full_unstemmed A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine
title_short A High-Throughput Size Exclusion Chromatography Method to Determine the Molecular Size Distribution of Meningococcal Polysaccharide Vaccine
title_sort high throughput size exclusion chromatography method to determine the molecular size distribution of meningococcal polysaccharide vaccine
url http://dx.doi.org/10.1155/2016/9404068
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