Replacement of in vivo human rabies vaccine potency testing by in vitro glycoprotein quantification using ELISA - Results of an international collaborative study.

Autor: Morgeaux S; Agence Nationale de Sécurité du Médicament et des Produits de Santé, Laboratory Controls Division, Batch Release and Marketing Surveillance of Biological Products Department, 312 Avenue Jean Jaurès, F-69007 Lyon, France., Poirier B; Independent Statistical Expert, 207 L'Ove, 69700 Chassagny, France., Ragan CI; European Partnership for Alternative Approaches to Animal Testing, Brussels, Belgium. Electronic address: ian.ragan1@btinternet.com., Wilkinson D; Division of Virology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK., Arabin U; GSK Vaccines GmbH, Emil-von-Behring-Straβe 76, 35041 Marburg, Germany., Guinet-Morlot F; Sanofi-Pasteur, 1541 av. Marcel Mérieux, 69280 Marcy L'Etoile, France., Levis R; Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Meyer H; Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany., Riou P; Sanofi-Pasteur, 1541 av. Marcel Mérieux, 69280 Marcy L'Etoile, France., Shaid S; GSK Vaccines GmbH, Emil-von-Behring-Straβe 76, 35041 Marburg, Germany., Volokhov D; Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Tordo N; Unité Stratégies Antivirales, Institut Pasteur, 25 rue du Dr. Roux, 75724 Paris Cedex 15, France; Institut Pasteur de Guinée, Conakry, Guinea., Chapsal JM; Independent Expert, 195 Traverse des Verdelières, 69380 Charnay, France.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2017 Feb 07; Vol. 35 (6), pp. 966-971. Date of Electronic Publication: 2017 Jan 09.
DOI: 10.1016/j.vaccine.2016.12.039
Abstrakt: Three different ELISAs quantifying rabies glycoprotein were evaluated as in vitro alternatives to the National Institutes of Health (NIH) in vivo potency test for batch release of human rabies vaccines. The evaluation was carried out as an international collaborative study supported by the European Partnership for Alternatives to Animal Testing (EPAA). This pre-validation study, the results of which are presented in this paper, compared three different ELISA designs, assessing their within- and between-laboratory precision. One of the ELISA designs was proposed to the European Directorate for the Quality of Medicines & HealthCare (EDQM) and accepted for an international collaborative study under the umbrella of the Biological Standardisation Programme.
(Copyright © 2017 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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