title: Evaluation of a candidate International Standard for Meningococcal Group C polysaccharide.
abstract: Meningococcal group C (MenC) plain polysaccharide (PS) and conjugate vaccines are primarily evaluated by physicochemical methods to ensure that batches are consistently manufactured. As different assays are employed to quantify the MenC PS content of final formulations and bulk intermediaries, there is a need for an International MenC PS Standard to calibrate internal references used in the different laboratories. Twelve laboratories from nine different countries participated in a collaborative study to determine the MenC PS content of a candidate International Standard MenC PS preparation (08/214) and to assess its suitability. On the basis of the results from this study the candidate standard 08/214 was established as an International Standard for the quantification of MenC PS content in vaccines and components. It has a content of 1.192 ± 0.192 mg MenC PS/ampoule (expanded uncertainty with coverage factor of k = 2.365 corresponding to a 95% level of confidence), as determined by the resorcinol assays carried out by eight of the participating laboratories. The standard is available from The National Institute of Biological Standards and Control who act as guardians and distributors of the material under the auspices of WHO.
authors.affiliation: Division of Bacteriology, NIBSC, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK. caroline.vipond@nibsc.hpa.org.uk
authors.forename: Caroline
authors.initials: C
authors.lastname: Vipond
authors.forename: Barbara
authors.initials: B
authors.lastname: Mulloy
authors.forename: Peter
authors.initials: P
authors.lastname: Rigsby
authors.forename: Karena
authors.initials: K
authors.lastname: Burkin
authors.forename: Barbara
authors.initials: B
authors.lastname: Bolgiano
mesh_terms: D002138:Calibration; D002626:Chemistry, Pharmaceutical; D054796:Drug Dosage Calculations; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods / Q000592:standards; D006801:Humans; D007394:International System of Units / Q000592:standards*; D038622:Internationality; D022401:Meningococcal Vaccines / Q000737:chemistry / Q000592:standards* / Q000627:therapeutic use; D011135:Polysaccharides, Bacterial / Q000276:immunology* / Q000592:standards / Q000627:therapeutic use; D011897:Random Allocation; D012015:Reference Standards
chemical_list: D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; C037676:meningococcal group C polysaccharide