[Development of alternative methods by the EDQM and the Biological Standardization Program]

Due to the complexity of their composition and mode of action and because of the absence of adequate alternative methods the quality control of biologicals (e.g. vaccines, sera) continues to be performed to a large extent in animal experiments. In most cases, the properties of the compounds are compared to those of a reference preparation. For Europe, the specifications for the biologicals are listed in the European Pharmacopoeia, which is published by the European Directorate for the Quality of Medicines (EDQM) in Strasbourg, on behalf of the member states. The EDQM is also in charge of the organisation of the Biological Standardisation Programme and the network of the national control laboratories (Official Medicines Control Laboratories, OMCL). The Biological Standardisation Programme pursues the goal to establish common European reference preparations and to standardise the methods used for the quality control of biologicals with the explicit goal to develop alternative methods whenever possible. This survey describes how the EDQM via the European Pharmacopoeia, the Biological Standardisation Programme and the OMCL network, supports the 3R concept and shows examples of its successful application.