The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM (Fraunhofer ITEM), Hannover, Germany, was founded in 1981. Fraunhofer ITEM is one of at present 72 institutions under the roof of the „Fraunhofer-Gesellschaft für angewandte Forschung e.V.“, Europe’s leading organization for applied research. Fraunhofer ITEM is a partly publicly funded, non-profit research institute focused on three business units, i.e. “Drug Development”, “Chemical Safety and Assessment”, and “Translational Biomedical Engineering”. Fraunhofer ITEM performs applied contract research for both public authorities and industrial partners from different sectors, including e.g. pharmaceutical, biomedical and chemical companies. Its unique structure enables Fraunhofer ITEM to be involved in a broad spectrum of pharmaceutical and biomedical engineering topics as well as the combination of both. In the sense of a one-stop-shop, Fraunhofer ITEM offers regulatory support, development of tailor-made and adapted testing systems for toxicology and safety assessment, preclinical studies and safety assessment according to international guidelines (OECD, ICH, EMA, ISO), and also prototyping. At present in vitro and in vivo assessment of health hazards evolving from nanomaterials, including mechanistic aspects, represent a special focus of research at Fraunhofer ITEM.
In the TBMED project, Fraunhofer ITEM focuses on regulatory strategy, data gap analysis, according to ISO 10993-1, and the development of product-adapted toxicological testing strategies. To assess toxicological risks at an early stage in the development process, material-specific (geno)toxicological screening methods will be devised. By leading the safety assessment Work Package 8, Fraunhofer ITEM is in charge of testing methods relevant for regulatory purposes such as biocompatibility testing according to ISO 10993-3 (genotoxicity) and ISO 10993-5 (cytotoxicity).