A routine high-performance size-exclusion chromatography to determine molecular size distribution of Haemophilus influenzae type b conjugate vaccines

Hunolstein, C von; Parisi, Laura; Recchia, Simona

doi:10.1016/s0264-410x(98)00166-2

Cited by 15 publications

(4 citation statements)

References 16 publications

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“…Previously published stability studies of Hib conjugate vaccines reported only on the short-term stability at higher temperatures. [12][13][14][15] Although Hib-TT conjugate vaccines currently have a three year shelf-life, this study also gave an opportunity to assess the effective stability of these lyophilized vaccines past their licensed expiry dates.…”

Section: Introductionmentioning

confidence: 99%

A Retrospective Study on the Quality of Haemophilus Influenzae Type B Vaccines Used in the U.K. Between 1996 and 2004

Bolgiano

Mawas²,

Burkin³

et al. 2007

Human Vaccines

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Following the reduction in efficacy of Hib-TT vaccines in the primary immunization schedule observed in the UK between 1999 and 2003, batches of vaccine manufactured by two different companies were retrospectively examined by the National Institute for Biological Standards and Control. The study evaluated 41 batches of the Hib-TT vaccines manufactured between 1994 and 2003, assaying potency (total PRP saccharide content), integrity (% free saccharide), consistency (molecular sizing), and immunogenicity, as well as reviewing data previously obtained at the time of release. The study indicated the stability of the lyophilized final fill vaccines to extend well past their assigned shelf-lives, and found no trends in the endotoxin content, total saccharide or % free saccharide content. A trend towards slightly larger conjugates was observed over time in Hib-TT A, evidenced in both the manufacturer's data obtained at the time that samples were submitted for testing and in data obtained from the retrospective analysis. The study confirmed that that there had been no significant change in the quality of the Hib vaccines that could possibly account for the change reported in their protective efficacy in the UK. The study also demonstrated the value of independent testing of vaccines from the time of licensure and in the ongoing monitoring and re-examination of selected batches, as necessary, to assure their continuing quality, safety and consistency.

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Section: Introductionmentioning

confidence: 99%

A Retrospective Study on the Quality of Haemophilus Influenzae Type B Vaccines Used in the U.K. Between 1996 and 2004

Bolgiano

Mawas²,

Burkin³

et al. 2007

Human Vaccines

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“…In particular, the efficacy of a PS vaccine is dependent on specific immunochemical and physical properties. The molecular size of polysaccharide is one of the major parameters which can be directly correlated with vaccine immunogenicity and potency [ 20 – 22 ]. This parameter is directly involved in inducing long-lasting immune memory [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

“…This parameter is directly involved in inducing long-lasting immune memory [ 23 ]. Moreover, during manufacturing steps it is crucial for routinely monitored batch-to-batch consistency [ 20 – 22 ].…”

Section: Introductionmentioning

confidence: 99%

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

Khan¹,

Rahman²,

Siraj³

et al. 2016

International Journal of Analytical Chemistry

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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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“…For example, Lee et al (2009) used size exclusion chromatography for the purification and analysis of a meningococcal conjugated vaccine. Hunolstein and colleagues von Hunolstein, Parisi & Bottaro, 2003;Von Hunolstein, Parisi & Recchia, 1999) used the PL Aquagel-OH 60 column to determine the molecular size distribution of high-molecular-weight Haemophilus influenzae type b-tetanus toxoid conjugate vaccines. Jumel, Ho & Bolgiano (2002) evaluated the mean molecular mass of three different protein-meningococcal C conjugates and their constituent proteins using a Superose 6 size exclusion chromatography column.…”

mentioning

confidence: 99%

Effects of solution conditions on characteristics and size exclusion chromatography of pneumococcal polysaccharides and conjugate vaccines

Hadidi

Buckley

Zydney

2016

Carbohydrate Polymers

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A routine high-performance size-exclusion chromatography to determine molecular size distribution of Haemophilus influenzae type b conjugate vaccines

Cited by 15 publications

References 16 publications

A Retrospective Study on the Quality of Haemophilus Influenzae Type B Vaccines Used in the U.K. Between 1996 and 2004

A Retrospective Study on the Quality of Haemophilus Influenzae Type B Vaccines Used in the U.K. Between 1996 and 2004

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

Effects of solution conditions on characteristics and size exclusion chromatography of pneumococcal polysaccharides and conjugate vaccines

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