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A novel enzyme-linked immuno-sorbent assay (ELISA) for the quantification of total and free polysaccharide in Haemophilus influenzae b-Tetanus toxoid conjugate vaccines in monovalent and combined vaccine formulations.
- Source :
-
Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2014 Jan; Vol. 42 (1), pp. 29-33. Date of Electronic Publication: 2013 Nov 05. - Publication Year :
- 2014
-
Abstract
- Current Haemophilus influenzae b conjugate vaccines (Hib), which are made of purified capsular polysaccharide (poly-ribosyl-ribitol-phosphate; PRP) conjugated to a carrier protein, are almost completely evaluated by physico-chemical methods to ensure the integrity and stability of the vaccine and consistency of manufacture of batches. The absence of a potency assay makes the quantification of total PRP content (in SI units) and of % free polysaccharide in final fills or bulk components of Hib vaccines critical release tests for both manufacturers and national control authorities. Here we describe a simple and sensitive Enzyme-Linked Immuno-sorbent Assay (ELISA) which has been developed to quantify total and free PRP content in Hib-TT vaccine alone or when in combination with other vaccines. The assay is robust, specific and highly sensitive.<br /> (Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.)
Details
- Language :
- English
- ISSN :
- 1095-8320
- Volume :
- 42
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Biologicals : journal of the International Association of Biological Standardization
- Publication Type :
- Academic Journal
- Accession number :
- 24200313
- Full Text :
- https://doi.org/10.1016/j.biologicals.2013.10.002