title: The vaccines consistency approach project: an EPAA initiative.
abstract: The consistency approach for release testing of established vaccines promotes the use of in vitro, analytical, non-animal based systems allowing the monitoring of quality parameters during the whole production process. By using highly sensitive non-animal methods, the consistency approach has the potential to improve the quality of testing and to foster the 3Rs (replacement, refinement and reduction of animal use) for quality control of established vaccines. This concept offers an alternative to the current quality control strategy which often requires large numbers of laboratory animals. In order to facilitate the introduction of the consistency approach for established human and veterinary vaccine quality control, the European Partnership for Alternatives to Animal Testing (EPAA) initiated a project, the "Vaccines Consistency Approach Project", aiming at developing and validating the consistency approach with stakeholders from academia, regulators, OMCLs, EDQM, European Commission and industry. This report summarises progress since the project's inception.
authors.affiliation: MSD Animal Health, PO Box 31, 5830 AA Boxmeer, Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: De Mattia
authors.affiliation: Utrecht University, Department of Animals in Science and Society, Faculty of Veterinary Medicine, PO Box 80.166, 3508TD Utrecht, Netherlands.
authors.forename: C
authors.initials: C
authors.lastname: Hendriksen
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
authors.forename: K H
authors.initials: KH
authors.lastname: Buchheit
authors.affiliation: Independent.
authors.forename: J M
authors.initials: JM
authors.lastname: Chapsal
authors.affiliation: European Commission, Joint Research Centre, Institute for Health and Consumer Protection, Systems Toxicology Unit/EURL ECVAM, 21027 Ispra, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Halder
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Lambrigts
authors.affiliation: Vaccine & Assay Consultancy, Watford, WD25 0EX, UK.
authors.forename: K
authors.initials: K
authors.lastname: Redhead
authors.affiliation: Rommel Consulting Partners, B-1370 Jodoigne, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Rommel
authors.affiliation: Novartis Vaccines and Diagnostics AG, Basel, Switzerland (currently: International AIDS Vaccine Initiative New York, New York, USA).
authors.forename: T
authors.initials: T
authors.lastname: Scharton-Kersten
authors.affiliation: Division of Bacteriology, National Institute for Biological Standards and Control (NIBSC). Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, United Kingdom.
authors.forename: T
authors.initials: T
authors.lastname: Sesardic
authors.affiliation: Novartis Vaccines and Diagnostics AG, Basel, Switzerland.
authors.forename: L
authors.initials: L
authors.lastname: Viviani
authors.affiliation: EPAA Project Coordinator.
authors.forename: I
authors.initials: I
authors.lastname: Ragan
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods* / Q000592:standards* / Q000639:trends; D000818:Animals; D005060:Europe; D006801:Humans; D011786:Quality Control; D014612:Vaccines / Q000592:standards*
chemical_list: D014612:Vaccines
keywords: 3Rs; EPAA; consistency testing; vaccine quality control