International collaborative study for establishment of the 2nd WHO International Standard for Haemophilus influenzae type b polysaccharide

• Published in: Biologicals Vol. 43; no. 6; pp. 492 - 503
• Main Authors: Mawas, Fatme, Burkin, Karena, Dougall, Thomas, Saydam, Manolya, Rigsby, Peter, Bolgiano, Barbara
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.11.2015
• Subjects: Bacterial Capsules - chemistry; Biological Assay - standards; Calibration; Chromatography, High Pressure Liquid; Drug Stability; Haemophilus influenzae; Haemophilus influenzae b; Haemophilus influenzae type b - chemistry; Haemophilus Vaccines - chemistry; Haemophilus Vaccines - standards; Hydrogen-Ion Concentration; International Cooperation; International standard; Laboratories - standards; Phosphorus - analysis; Polysaccharide; Polysaccharides - analysis; Polysaccharides - standards; Polysaccharides, Bacterial - analysis; Polysaccharides, Bacterial - standards; Reference Standards; Reproducibility of Results; Ribose - analysis; World Health Organization; Polysaccharide; Haemophilus influenzae b; International standard
• ISSN: 1045-1056; 1095-8320
• DOI: 10.1016/j.biologicals.2015.07.006

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.