title: Replacement of in vivo human rabies vaccine potency testing by in vitro glycoprotein quantification using ELISA - Results of an international collaborative study.
abstract: 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.
authors.affiliation: 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.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Morgeaux
authors.affiliation: Independent Statistical Expert, 207 L'Ove, 69700 Chassagny, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Poirier
authors.affiliation: European Partnership for Alternative Approaches to Animal Testing, Brussels, Belgium. Electronic address: ian.ragan1@btinternet.com.
authors.forename: C Ian
authors.initials: CI
authors.lastname: Ragan
authors.affiliation: Division of Virology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.
authors.forename: Dianna
authors.initials: D
authors.lastname: Wilkinson
authors.affiliation: GSK Vaccines GmbH, Emil-von-Behring-Straβe 76, 35041 Marburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Arabin
authors.affiliation: Sanofi-Pasteur, 1541 av. Marcel Mérieux, 69280 Marcy L'Etoile, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Guinet-Morlot
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Levis
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.
authors.forename: Heidi
authors.initials: H
authors.lastname: Meyer
authors.affiliation: Sanofi-Pasteur, 1541 av. Marcel Mérieux, 69280 Marcy L'Etoile, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Riou
authors.affiliation: GSK Vaccines GmbH, Emil-von-Behring-Straβe 76, 35041 Marburg, Germany.
authors.forename: Shahjahan
authors.initials: S
authors.lastname: Shaid
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Dmitriy
authors.initials: D
authors.lastname: Volokhov
authors.affiliation: Unité Stratégies Antivirales, Institut Pasteur, 25 rue du Dr. Roux, 75724 Paris Cedex 15, France; Institut Pasteur de Guinée, Conakry, Guinea.
authors.forename: Noël
authors.initials: N
authors.lastname: Tordo
authors.affiliation: Independent Expert, 195 Traverse des Verdelières, 69380 Charnay, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Chapsal
mesh_terms: D000818:Animals; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards*; D005060:Europe; D006023:Glycoproteins / Q000032:analysis / Q000276:immunology; D006801:Humans; D007391:International Cooperation; D015588:Observer Variation; D011818:Rabies / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D011819:Rabies Vaccines / Q000494:pharmacology / Q000592:standards*; D011820:Rabies virus / Q000276:immunology; D015203:Reproducibility of Results; D064166:Vaccine Potency; D014764:Viral Proteins / Q000032:analysis* / Q000276:immunology
chemical_list: D006023:Glycoproteins; D011819:Rabies Vaccines; D014764:Viral Proteins
keywords: ELISA; Human; In vitro; NIH test; Rabies; Vaccine