title: Reduction of animal use in human vaccine quality control: opportunities and problems.
abstract: In vivo assays play a crucial role in the assessment of the potency and safety of human vaccines. Robust vaccine production procedures, improved characterisation methods and development of well-characterised vaccines create possibilities to reduce animal use. In this paper the current status in this field is reviewed. Achievements with regard to in vivo and in vitro potency and safety testing are discussed as well as new developments and possibilities in the field of in vitro characterisation of vaccine components. Finally, validation and implementation issues will be dealt with. Although replacement of in vivo tests for batch release of existing vaccines is difficult, emerging technologies allow well-considered reduction of in vivo experiments during product and process development and improvement. Inextricably bound up with this approach is good manufacturing practice (GMP), resulting in robust, validated production processes.
authors.affiliation: Laboratory for Product and Process Development, National Institute of Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands. bernard.metz@rivm.nl
authors.forename: Bernard
authors.initials: B
authors.lastname: Metz
authors.forename: Coenraad F M
authors.initials: CF
authors.lastname: Hendriksen
authors.forename: Wim
authors.initials: W
authors.lastname: Jiskoot
authors.forename: Gideon F A
authors.initials: GF
authors.lastname: Kersten
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D006801:Humans; D011786:Quality Control; D014612:Vaccines / Q000009:adverse effects / Q000592:standards*
chemical_list: D014612:Vaccines