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PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2004-3-30
pubmed:abstractText
The development of an analytical procedure for the evaluation of a conjugate vaccine's structural wholeness or integrity is described. The principle component of the vaccine was the N-propionylated group B meningococcal polysaccharide (NPr-GBMP) covalently attached to a carrier protein. The goal of the procedure was to determine whether any whole polysaccharide, oligosaccharide, or monosaccharide, from minute to moderate levels, became detached off the conjugate. Free saccharide was isolated from the formulation, which included an aluminum hydroxide adjuvant for analysis. Due to its linkage, the NPr-GBMP did not release sialic acid efficiently with acid hydrolysis to the extent necessary for accurate quantitation. To accomplish depolymerization, the NPr-GBMP was subjected to methanolysis, 3N hydrochloric acid in methanol for 16h at 80 degrees C. The main product of the methanolysis reaction was a de-N-acylated methyl glycoside of sialic acid. N-acetylneuraminic acid oligomers and colominic acid were used to confirm the methanolysis depolymerization efficiency of the alpha(2 --> 8) saccharides; with the treatment all oligomers produced a common methyl glycoside. For this determination anion exchange chromatography and size exclusion chromatography were both interfaced to an integrated pulsed amperometric detector. Sensitivity and linearity were demonstrated to be sufficient for the application with vaccine dose formulations with low total saccharide concentrations.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
0003-2697
pubmed:author
pubmed:issnType
Print
pubmed:day
15
pubmed:volume
327
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
261-70
pubmed:dateRevised
2008-11-21
pubmed:meshHeading
pubmed-meshheading:15051544-Bacterial Capsules, pubmed-meshheading:15051544-Carbohydrate Sequence, pubmed-meshheading:15051544-Carbohydrates, pubmed-meshheading:15051544-Chromatography, Ion Exchange, pubmed-meshheading:15051544-Hydrochloric Acid, pubmed-meshheading:15051544-Mass Spectrometry, pubmed-meshheading:15051544-Meningococcal Infections, pubmed-meshheading:15051544-Meningococcal Vaccines, pubmed-meshheading:15051544-Methanol, pubmed-meshheading:15051544-Molecular Sequence Data, pubmed-meshheading:15051544-Molecular Structure, pubmed-meshheading:15051544-N-Acetylneuraminic Acid, pubmed-meshheading:15051544-Neisseria meningitidis, Serogroup B, pubmed-meshheading:15051544-Polysaccharides, pubmed-meshheading:15051544-Polysaccharides, Bacterial, pubmed-meshheading:15051544-Vaccines, Conjugate
pubmed:year
2004
pubmed:articleTitle
An integrity assay for a meningococcal type B conjugate vaccine.
pubmed:affiliation
BioScience Division, Baxter Healthcare Corp., 12140 Indian Creek Ct., Beltsville, MD 20705, USA. vinnie_turula@baxter.com
pubmed:publicationType
Journal Article, Evaluation Studies