International collaborative study for establishment of the 2nd WHO International Standard for Haemophilus influenzae type b polysaccharide. Issue 6 (November 2015)

• Record Type: Journal Article
• Authors: Mawas, Fatme; Burkin, Karena; Dougall, Thomas; Saydam, Manolya; Rigsby, Peter; Bolgiano, Barbara
• Is Part Of: Biologicals. Volume 43:Issue 6(2015:Nov.)
• Page Start: 492
• Page End: 503
• Publication Date: 2015-11
• Subjects: Haemophilus influenzae b -- Polysaccharide -- International standard; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2015.07.006
• Languages: English
• ISSNs: 1045-1056

Abstract

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 ± 0.185 mg/ampoule, as determined by the ribose assays carried out by 11 of the participating laboratories.