Next generation risk assessment to set the stage for the future
Fraunhofer ITEM stands for toxicology testing and risk assessment of chemicals, active substances and drugs – with a focus on inhalation toxicology. Continued development of the corresponding exposure methods enables very small amounts of test substances to be used with high efficiency in toxicological studies.
While conventional toxicology testing is still the required regulatory standard, our researchers are contributing to new assessment strategies through their own research projects based on the next generation risk assessment concept, aiming to provide predictive models for assessing the safety of compounds.
Based on the precision-cut lung slices (PCLS) technology that is well established at the institute, more human or humanized ex-vivo organ models, for example of the heart and liver, are in the process of further development. These models can also be used to test biopharmaceuticals and advanced therapy medicinal products (ATMPs). To analyze the results, the researchers combine the traditional endpoints among others with omics technologies, in particular metabolomics and functional genomics, and complex advanced bioinformatics analyses.
Assessment methods based on databases, such as the TTC (threshold of toxicological concern) concept, are being further developed, for example to identify non-genotoxic tumorigenic substances or to allow these methods to be used for the development of medical devices as well.
Fraunhofer Institute for Toxicology and Experimental Medicine