Quality-control issues and approaches in vaccine development.
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.
Metz
Bernard
B
Research and Development Unit, Netherlands Vaccine Institute, Bilthoven, The Netherlands. bernard.metz@nvi-vaccin.nl
van den Dobbelsteen
Germie
G
van Els
Cécile
C
van der Gun
Johan
J
Levels
Lonneke
L
van der Pol
Leo
L
Rots
Nynke
N
Kersten
Gideon
G
D006801:Humans; D011786:Quality Control; D014612:Vaccines / Q000592:standards*
D014612:Vaccines