title: International collaborative study for establishment of the 2nd WHO International Standard for Haemophilus influenzae type b polysaccharide.
abstract: In this report we present the results of a collaborative study for the preparation and calibration of a replacement International Standard (IS) for Haemophilus influenzae type b polysaccharide (polyribosyl ribitol phosphate; 5-d-ribitol-(1 → 1)-β-d-ribose-3-phosphate; PRP). Two candidate preparations were evaluated. Thirteen laboratories from 9 different countries participated in the collaborative study to assess the suitability and determine the PRP content of two candidate standards. On the basis of the results from this study, Candidate 2 (NIBSC code 12/306) has been established as the 2nd WHO IS for PRP by the Expert Committee of Biological Standards of the World Health Organisation with a content of 4.904 ± 0.185mg/ampoule, as determined by the ribose assays carried out by 11 of the participating laboratories.
authors: Division of Bacteriology, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK. Electronic address: Fatme.mawas@nibsc.org.
authors: Fatme
authors: F
authors: Mawas
authors: Division of Bacteriology, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK.
authors: Karena
authors: K
authors: Burkin
authors: Biostatistics Group, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK.
authors: Thomas
authors: T
authors: Dougall
authors: Division of Bacteriology, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK.
authors: Manolya
authors: M
authors: Saydam
authors: Biostatistics Group, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK.
authors: Peter
authors: P
authors: Rigsby
authors: Division of Bacteriology, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK.
authors: Barbara
authors: B
authors: Bolgiano
mesh_terms: D016667:Bacterial Capsules / Q000737:chemistry; D001681:Biological Assay / Q000592:standards; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D018073:Haemophilus Vaccines / Q000737:chemistry / Q000592:standards; D019741:Haemophilus influenzae type b / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D007391:International Cooperation; D007753:Laboratories / Q000592:standards; D010758:Phosphorus / Q000032:analysis; D011134:Polysaccharides / Q000032:analysis / Q000592:standards*; D011135:Polysaccharides, Bacterial / Q000032:analysis / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D012266:Ribose / Q000032:analysis; D014944:World Health Organization
chemical_list: D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D011134:Polysaccharides; D011135:Polysaccharides, Bacterial; D010758:Phosphorus; C008984:polyribitol phosphate; D012266:Ribose
keywords: Haemophilus influenzae b; International standard; Polysaccharide