title: Quality-control issues and approaches in vaccine development.
abstract: The successful development of vaccines is a lengthy process, requiring input from different expertises, such as research and development, quality control, quality assurance, production, regulatory affairs, and marketing and sales. A cornerstone in vaccine development is the availability of a panel of high-quality assays that can reduce the risk of failure in clinical trials and licensure. This review highlights the quality-control issues and approaches in vaccine development from different viewpoints: discovery, process development, assay development, clinical development and the postlicensing phase.
authors.affiliation: Research and Development Unit, Netherlands Vaccine Institute, Bilthoven, The Netherlands. bernard.metz@nvi-vaccin.nl
authors.forename: Bernard
authors.initials: B
authors.lastname: Metz
authors.forename: Germie
authors.initials: G
authors.lastname: van den Dobbelsteen
authors.forename: Cécile
authors.initials: C
authors.lastname: van Els
authors.forename: Johan
authors.initials: J
authors.lastname: van der Gun
authors.forename: Lonneke
authors.initials: L
authors.lastname: Levels
authors.forename: Leo
authors.initials: L
authors.lastname: van der Pol
authors.forename: Nynke
authors.initials: N
authors.lastname: Rots
authors.forename: Gideon
authors.initials: G
authors.lastname: Kersten
mesh_terms: D006801:Humans; D011786:Quality Control; D014612:Vaccines / Q000592:standards*
chemical_list: D014612:Vaccines