Bf3R-VALIDITIE: Validation platform for animal-free testing methods

Animal testing has been a central component of the regulatory approval process for chemicals, pesticides, biocides and pharmaceuticals to protect consumers and patients from potential health risks. In the future, these tests should be carried out without animal testing wherever possible. To this end, so-called New Approach Methods (NAMs) are increasingly being used as animal-free testing methods. However, these methods must be independently evaluated and recognized internationally in order to deliver reliable, meaningful and reproducible results.

The validation of alternative methods is a key step towards replacing animal testing with animal-free methods. In the course of a validation study the reproducibility is evaluated as well as if the method is suitable for its intended purpose. To this end, a sufficient number of substances are tested in a blinded manner in several independent laboratories. This serves to prove that the method produces the same result for the same substance in different laboratories. Following an independent scientific peer review, new methods can be adopted in regulatory test guidelines, for example by the Organization for Economic Cooperation and Development (OECD) or the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The inclusion of new methods in the OECD Test Guideline Program is managed by the “Working Group of National Coordinators of the Test Guidelines Program” (WNT), for which the Bf3R provides the National Coordinator for the field of human health. If the method is adopted, it can be used for the legally compliant evaluation of
substances in regulatory processes.
Validation studies thus form the basis for the scientific and regulatory recognition of alternative methods. Only through the targeted selection, standardization and validation of new test methods can the number of laboratory animals used for regulatory purposes be substantially reduced.
 

To accelerate the validation of animal-free testing methods, the German Centre for the Protection of Laboratory Animals (Bf3R) at the Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) is establishing validation platform: Bf3R-VALIDITIE. Funding for this project is provided by the Federal Ministry of Food and Agriculture (BMLEH) under Chapter 1005, Title 686 32 (“Measures to reduce animal testing”).
The platform is expected to be operational by the end of 2027, enabled to carry out validation studies efficiently and successfully. To achieve this goal, the Bf3R is collaborating with the French validation platform PEPPER that has been establishing effective and quality-assured validation processes since 2019. The Bf3R currently supports and cooperates with PEPPER to promote knowledge exchange and collaboration. In addition, a laboratory infrastructure is created that can be used for the standardization of novel and relevant methods (e.g. high-throughput, organoid, and organ-on-a-chip assays). This structure will facilitate the preparation and execution of validation studies with the aim of increasing the number of animal-free testing methods that are validated and accepted in regulatory processes.