Inactivated rabies vaccine control and release:use of an ELISA method

Quality control of human rabies vaccines performed by National Control Laboratories (NCLs) prior to marketing vaccines batches requires in vivo and in vitro potency assays as requested by the relevant European Pharmacopoeia monographs, OMCLs guidelines and WHO technical recommendations. The aim of t...

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Bibliographic Details
Published in:Biologicals 2003-03, Vol.31 (1), p.9-16
Main Authors: Fournier-Caruana, Jacqueline, Poirier, Bertrand, Haond, Geneviève, Jallet, Corinne, Fuchs, Florence, Tordo, Noël, Perrin, Pierre
Format: Article
Language:English
Subjects:
Batch release
Dose-Response Relationship, Immunologic
ELISA method
Enzyme-Linked Immunosorbent Assay - methods
Glycoprotein
Humans
Quality Control
Rabies vaccine
Rabies Vaccines - administration & dosage
Rabies Vaccines - standards
Statistics
Vaccines, Inactivated - administration & dosage
Vaccines, Inactivated - standards
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Summary:Quality control of human rabies vaccines performed by National Control Laboratories (NCLs) prior to marketing vaccines batches requires in vivo and in vitro potency assays as requested by the relevant European Pharmacopoeia monographs, OMCLs guidelines and WHO technical recommendations. The aim of the present study was to check the suitability of an enzyme-linked immunosorbent assay (ELISA) using a virus neutralizing monoclonal antibody, directed to the rabies virus glycoprotein, to monitor the consistency of the lot to lot rabies vaccines production. Furthermore, this work was implemented to establish in house specifications for the glycoprotein content.
ISSN:1045-1056
1095-8320
DOI:10.1016/S1045-1056(02)00070-2