Animal research at Fraunhofer ITEM

Animal testing is essential for achieving progress in biological and medical research. It provides insights that can then be used to develop new medicines and treatments, and to assess health risks. These findings are so beneficial to humans, but come at a cost to the animals.

At Fraunhofer ITEM, we test the efficacy and safety of drugs, chemicals and medical devices. We perform these pharmacological, toxicological and safety pharmacology studies on rodents. Our studies are conducted in accordance with the international approval regulations issued by the OECD and the EMA. In 1991, the institute was granted GLP certification pursuant to the Chemicals Act or Directive 2004/9/EC.

It goes without saying that, in our research work, we treat all animals humanely and observe strict hygiene conditions, and that all tests are conducted responsibly. Our veterinarians and animal keepers, as well as our animal welfare officers, are involved in the planning and execution of the tests.

For many years, we have been working to minimize animal testing, replace it with alternative processes, and develop and establish new alternative methods. In recent years, an average of 2,000 to 2,500 mice and rats have been used for animal studies at Fraunhofer ITEM. For comparison, here is a detailed record of the numbers of animals used in research in Germany. 

Animal numbers Fraunhofer ITEM
© Fraunhofer ITEM
In recent years, an average of 2,000 to 2,500 mice and rats have been used for animal studies at Fraunhofer ITEM.

Ethics in animal research

Any test involving animals must be preceded by an evaluation of whether the expected benefit for humans outweighs the expected harm to the animal - the ethical duty to minimize animal suffering is also enshrined in the German Animal Welfare Act. This harm must also be kept to an absolute minimum. Only then can the test be considered “ethically justifiable”.

If we take a systematic approach to these obligations, we arrive at the principle of the “3 Rs”. These are the three central aspects “replacement”, “reduction” and “refinement”, which have been introduced as essential requirements for testing practice and must be demonstrated as part of the approval process for any test involving animals. The “3 Rs” form a guiding principle and ethical frame of reference for animal research at Fraunhofer ITEM.

Alternatives to animal testing

Fraunhofer CIMD platform: Alternative methods to animal testing
© Fraunhofer ITEM, Ralf Mohr
Developing and improving alternatives to animal testing is a top priority at Fraunhofer ITEM.

When it comes to scientific research that requires the study of complex mechanisms in a living organism, there are currently very few alternative processes available.

We develop new alternatives to animal testing, work with alternative methods wherever we can, and ensure that our in-vivo tests on rodents are always conducted responsibly and only to the extent that is necessary or legally required. 

Fraunhofer CIMD platform: Alternative methods to animal testing

At the same time, Fraunhofer institutes — led by Fraunhofer ITEM — are actively involved in the development and improvement of alternative methods by means of a shared competence platform within the Fraunhofer Cluster of Excellence for Immune-Mediated Diseases CIMD. These methods involve, for example, various human cell and tissue models, organoids, organ-on-a-chip models, in-silico toxicology, omics technology, bioinformatics and laboratory automation.

More information on the competence platform “Alternative methods to animal testing”


If you have any questions or suggestions, please do not hesitate to get in touch.

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Animal research and animal welfare

Fraunhofer Institute for Toxicology and Experimental Medicine
Nikolai-Fuchs-Str. 1
30625 Hannover