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Vaccine Research and Development Methodology

Cell Biology

  1. Jens-Peter Gregersen

Published Online: 15 SEP 2006

DOI: 10.1002/3527600906.mcb.200400125

Reviews in Cell Biology and Molecular Medicine

Reviews in Cell Biology and Molecular Medicine

How to Cite

Gregersen, J.-P. 2006. Vaccine Research and Development Methodology. Reviews in Cell Biology and Molecular Medicine. .

Author Information

  1. Chiron Vaccines, Chiron-Behring GmbH & Co KG, Marburg, Germany

Publication History

  1. Published Online: 15 SEP 2006

Abstract

Vaccine research and vaccine development are commonly combined by the term R&D because, in practice, these two different disciplines cannot be easily separated. However, there are fundamental differences. Research is mainly motivated by, and aiming at, scientific publications, which are best achieved by new methods, inventions, and discoveries. Development is aiming at innovations, that is, new products that will have an impact on our daily life. In research, a vaccine could be an antigen or a preparation that has the potential of eliminating or inhibiting microorganisms. In order to convert this into a useful vaccine, developers must then add several other dimensions to the research product, namely, quality, safety, a specifically defined clinical efficacy, and practical utility. For a successful development not only scientific but also technological, commercial, and regulatory hurdles must be taken. Designing practical utility into a product encompasses and combines almost any aspect of the product, including a good tolerability, acceptable application schemes with only few vaccinations, a proven and perceived effectiveness, comfortable presentation forms, formulations that guarantee good stability and shelf lives, and, of course, adequate product cost.

Keywords:

  • Clinical Research and Development;
  • Preclinical Research and Development;
  • Vaccine