Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer ITEM offers comprehensive toxicological expertise for the testing and safety assessment of chemicals, pharmaceuticals, and medical devices – ranging from exposure characterization and the generation of toxicological data to regulatory consulting and support throughout approval and registration processes. A particular focus lies on inhalation toxicology and the realistic characterization of inhalable substances. State-of-the-art exposure technologies enable the efficient use of very small substance quantities in toxicological studies.
Human-based models and innovative testing strategies
Toxicological research at Fraunhofer ITEM is consistently aligned with the ethical 3R principle. The targeted use of alternative, human-based test systems reduces animal testing while increasing the relevance of results for humans. Established and continuously advanced human in vitro and ex vivo models – including precision-cut lung slices (PCLS) and other human or humanized organ models – are also applied to the testing of biopharmaceuticals and advanced therapy medicinal products (ATMPs).