Spec. Issue 2006 - Article Summary

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Development of alternatives for quality control of biomedicines: The example of vaccines for human use

Marie-Emmanuelle Behr-Gross
European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, France
Summary
The European Directorate for the Quality of Medicines (EDQM) co-ordinates the elaboration of the European Pharmacopoeia. Within the field of biomedicines, the EDQM has been able to implement high standards due to the contribution of experts and to the European Biological Standardisation Programme (BSP). The aim of the BSP is to establish reference methods and preparations with a focus on alternatives to animal testing: potency assay validation studies for vaccines illustrate the potential contributions of the BSP to animal welfare. The successful projects run for diphtheria and tetanus vaccines will be extended. Based on the assumption that sera from the same animals (guinea pigs) could be used for in vitro determination of antibodies to different components of combined vaccines, the
potential for reduction and refinement of the routine vaccines batch potency assay by this approach is substantial and will be further explored by the BSP.

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