title: A versatile in vitro ELISA test for quantification and quality testing of infectious, inactivated and formulated rabies virus used in veterinary monovalent or combination vaccine.
abstract: Regulatory potency test for rabies vaccines requires mice vaccination followed by challenge with a live virus via intracerebral route. An alternative in vitro test, consistent with the "3R's" (Reduce, Replace, Refine) was designed to quantify active glycoprotein G using seroneutralizing monoclonal antibodies. This versatile ELISA targets well conformed neutralizing epitopes. Therefore, it quantifies only the trimeric pre-fusion form of glycoprotein G known to elicits the production of viral neutralizing antibodies. The ELISA makes it possible to quantify the rabies antigen during all steps of the product cycle (i.e. viral cultivation, downstream process, formulation and product stability in the presence of aluminum gel or other vaccine valence). Moreover, the batch-to-batch consistency of our active ingredients and formulated products could be demonstrated.
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France. Electronic address: cecile.sigoillot-claude@merial.com.
authors.forename: Cécile
authors.initials: C
authors.lastname: Sigoillot-Claude
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Myriam
authors.initials: M
authors.lastname: Battaglio
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Fiorucci
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Delphine
authors.initials: D
authors.lastname: Gillet
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Vimort
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: Giraud
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Sonia
authors.initials: S
authors.lastname: Laurent
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Vaganay
authors.affiliation: MERIAL, R&D, 254 rue Marcel Mérieux, 36-3B, 69007 Lyon, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Poulet
mesh_terms: D000818:Animals; D000956:Antigens, Viral / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D008807:Mice, Inbred BALB C; D011819:Rabies Vaccines / Q000276:immunology* / Q000592:standards; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D064166:Vaccine Potency; D015164:Vaccines, Inactivated / Q000276:immunology / Q000592:standards; D014730:Veterinary Medicine / Q000379:methods* / Q000592:standards
chemical_list: D000956:Antigens, Viral; D011819:Rabies Vaccines; D015164:Vaccines, Inactivated
keywords: 3Rs; Antigenically active glycoprotein; ELISA method; In vitro alternative method; Rabies vaccine control