Toxic effects, especially in the cardiac and neuronal area, are the main reasons why promising drug candidates have to be withdrawn in late preclinical studies or even later after market approval. State of the art in drug research are still in vitro cell culture models based on animal cells or in vivo animal experiments. Both systems can usually only be transferred to the human system to an insufficient extent, so that side effects are discovered late and result in both economic and health damage. Therefore, there is an urgent need for significant test systems that allow a reliable prediction of possible drug-induced toxicities in humans.
R2U-Tox-Assay is being worked on by three project participants: The Fraunhofer Institute for Biomedical Engineering IBMT in Sulzbach (Saarland) is coordinating the project and is responsible in particular for the tasks of producing significant human cell systems and freezing them in application-oriented formats. Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, will validate the developed test systems in the pharmaceutical environment in already established drug screenings. The Institute for Bioengineering of Catalonia establishes genedited so-called reporter cell lines, which allow a faster analysis of potentially toxic effects within the cell system.
Sources and further information:
https://www.ibmt.fraunhofer.de
https://eithealth.eu/project/r2u-tox-assay/