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Updated: Jun 25, 2026

Expression and Purification of Virus-like Particles for Vaccination
Published on: June 2, 2016
Quality-control issues and approaches in vaccine development
Bernard Metz1, Germie van den Dobbelsteen, Cécile van Els
1Research and Development Unit, Netherlands Vaccine Institute, Bilthoven, The Netherlands. bernard.metz@nvi-vaccin.nl
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.
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