title: Evaluation of the saccharide content and stability of the first WHO International Standard for Haemophilus influenzae b capsular polysaccharide.
abstract: Haemophilus influenzae b conjugate vaccines (Hib) are almost entirely evaluated by physico-chemical methods to ensure the consistency of manufacture of batches. As different assays are employed for the quantification of Hib capsular polysaccharide PRP (polyribosyl ribitol phosphate; 5-D-ribitol-(1-->1)-beta-D-ribose-3-phosphate) in final formulations and bulk components, there was deemed a need for an International Standard of Hib PRP polysaccharide to be made available. Ten laboratories from 8 different countries participated in a collaborative study to determine the PRP content and assess the suitability of a candidate International Standard PRP preparation (02/208). The results illustrate that a reduction in between-laboratory variability could be achieved by use of a common reference preparation and data analysis showed no significant differences in the values obtained by the different assays: ribose, phosphorus, and high performance anion exchange chromatography-pulsed amperometric detection (HPAEC-PAD), suggesting the suitability of the proposed reference for use across these assays for quantification of PRP content in Hib vaccines. On the basis of the results of this study, the First International Standard for PRP, NIBSC Code 02/208, has been established by the Expert Committee of Biological Standards of the World Health Organisation, with a content of 4.933+/-0.267mg/ampoule, as determined by the ribose assays carried out by 7 of the participating laboratories.
authors.affiliation: Bacteriology Division, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, UK. fmawas@nibsc.ac.uk
authors.forename: Fatme
authors.initials: F
authors.lastname: Mawas
authors.forename: Barbara
authors.initials: B
authors.lastname: Bolgiano
authors.forename: Peter
authors.initials: P
authors.lastname: Rigsby
authors.forename: Dennis
authors.initials: D
authors.lastname: Crane
authors.forename: Danielle
authors.initials: D
authors.lastname: Belgrave
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Corbel
mesh_terms: D016667:Bacterial Capsules; D002241:Carbohydrates / Q000032:analysis; D003299:Cooperative Behavior; D004355:Drug Stability; D018073:Haemophilus Vaccines / Q000737:chemistry* / Q000592:standards*; D019741:Haemophilus influenzae type b / Q000737:chemistry*; D007391:International Cooperation; D011135:Polysaccharides, Bacterial / Q000737:chemistry*; D012015:Reference Standards; D014944:World Health Organization
chemical_list: D002241:Carbohydrates; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D011135:Polysaccharides, Bacterial