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Evaluation of a candidate International Standard for Meningococcal Group C polysaccharide.
- Source :
-
Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2012 Sep; Vol. 40 (5), pp. 353-63. Date of Electronic Publication: 2012 May 22. - Publication Year :
- 2012
-
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.<br /> (Copyright © 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.)
- Subjects :
- Calibration
Chemistry, Pharmaceutical
Drug Dosage Calculations
Drug Stability
Drug Storage methods
Drug Storage standards
Humans
Internationality
Meningococcal Vaccines chemistry
Meningococcal Vaccines therapeutic use
Polysaccharides, Bacterial standards
Polysaccharides, Bacterial therapeutic use
Random Allocation
Reference Standards
International System of Units standards
Meningococcal Vaccines standards
Polysaccharides, Bacterial immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1095-8320
- Volume :
- 40
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Biologicals : journal of the International Association of Biological Standardization
- Publication Type :
- Academic Journal
- Accession number :
- 22622331
- Full Text :
- https://doi.org/10.1016/j.biologicals.2012.03.003