Quantitation of serogroups in multivalent polysaccharide-based meningococcal vaccines: Optimisation of hydrolysis conditions and chromatographic methods

Cook, Matthew; Bliu, Alex; Kunkel, Jeremy P.

doi:10.1016/j.vaccine.2013.05.098

Cited by 20 publications

(14 citation statements)

References 35 publications

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“…The hydrolysis conditions chosen (2M TFA, 100 • C, 5 h) were reported to provide excellent recoveries of hexoses (95-100%) and hexosamines (>90%) from bacterial polysaccharide vaccines, but caused essentially complete destruction (<1% recovery) of sialic acids [85]. Conversely, the relatively mild hydrolysis conditions optimal for sialic acid recovery were too weak for acceptable recoveries of the other monosaccharides.…”

Section: Glycan Hydrolysis and Monosaccharide Analysis By Hpaec-padmentioning

confidence: 99%

Comparison of orthogonal chromatographic and lectin-affinity microarray methods for glycan profiling of a therapeutic monoclonal antibody

Cook

Kaldas

Muradia

et al. 2015

Journal of Chromatography B

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Section: Glycan Hydrolysis and Monosaccharide Analysis By Hpaec-padmentioning

confidence: 99%

Comparison of orthogonal chromatographic and lectin-affinity microarray methods for glycan profiling of a therapeutic monoclonal antibody

Cook

Kaldas

Muradia

et al. 2015

Journal of Chromatography B

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“…TFA hydrolysates were dried and reconstituted in water prior to chromatography. As bulk conjugates and final fills contained sucrose as a formulation sugar, a Microsep ® 3K filter (Pall Corporation, Port Washington, NY, USA) was used to replace sucrose with water before hydrolysis [ 41 ]. Validation of this step for a MenC-containing vaccine showed no loss of saccharide, free or total.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use

et al. 2021

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Towards achieving the goal of eliminating epidemic outbreaks of meningococcal disease in the African meningitis belt, a pentavalent glycoconjugate vaccine (NmCV-5) has been developed to protect against Neisseria meningitidis serogroups A, C, Y, W and X. MenA and X polysaccharides are conjugated to tetanus toxoid (TT) while MenC, Y and W polysaccharides are conjugated to recombinant cross reactive material 197 (rCRM197), a non-toxic genetic variant of diphtheria toxin. This study describes quality control testing performed by the manufacturer, Serum Institute of India Private Limited (SIIPL), and the independent control laboratory of the U.K. (NIBSC) on seven clinical lots of the vaccine to ensure its potency, purity, safety and consistency of its manufacturing. In addition to monitoring upstream-manufactured components, samples of drug substance, final drug product and stability samples were evaluated. This paper focuses on the comparison of the vaccine’s critical quality attributes and reviews key indicators of its stability and immunogenicity. Comparable results were obtained by the two laboratories demonstrating sufficient levels of polysaccharide O-acetylation, consistency in size of the bulk conjugate molecules, integrity of the conjugated saccharides in the drug substance and drug product, and acceptable endotoxin content in the final drug product. The freeze-dried vaccine in 5-dose vials was stable based on molecular sizing and free saccharide assays. Lot-to-lot manufacturing consistency was also demonstrated in preclinical studies for polysaccharide-specific IgG and complement-dependent serum bactericidal activity for each serogroup. This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India.

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“…Assaying the polysaccharide content of each of the four polysaccharides in the tetravalent meningococcal vaccine using only HPAE-PAD was described by the Centre for Vaccine Evaluation, Biologics and Genetic Therapies Directorate of Health Canada. 26 They determined optimal acid hydrolysis conditions for each serotype polysaccharide, and then they measured one monosaccharide for each serotype. Optimization involved testing with multiple monovalent and polyvalent vaccines in different formulations.…”

Section: Neisseria Meningitidis Vaccinesmentioning

confidence: 99%

Vaccine Quality Ensured by High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection

Rohrer

2020

SLAS Technology

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Quantitation of serogroups in multivalent polysaccharide-based meningococcal vaccines: Optimisation of hydrolysis conditions and chromatographic methods

Cited by 20 publications

References 35 publications

Comparison of orthogonal chromatographic and lectin-affinity microarray methods for glycan profiling of a therapeutic monoclonal antibody

Comparison of orthogonal chromatographic and lectin-affinity microarray methods for glycan profiling of a therapeutic monoclonal antibody

Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use

Vaccine Quality Ensured by High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection

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