CoHMed MS-Tox Test: Application-oriented optimization of the DIN-ISO standardized cytotoxicity test of medical devices by combined mass spectrometric metabolome analyses on test by-products for the elucidation of cellular mechanisms with the aim of increasing the significance in a material-saving manner
Cytotoxicity testing is an important test method in the context of biological evaluation of medical devices (DIN EN ISO 10993 series of standards). The in-vitro cytotoxicity assay plays an important role here as it generally characterizes cytotoxicity, but without identifying the exact cause.
Metabolites as biomarkers for toxicity reactions are to be identified by mass spectrometry for a more comprehensive assessment in close cooperation with the company CleanControlling Medical GmbH during this project. Combining the standardized cytotoxicity assay with mass spectrometry is expected to increase the power of such assays, detect material-induced changes (and potential risks) earlier and more sensitively at the molecular level.
Mass spectroscopy will be used to control the extraction success, and thus to be able to establish one or more extraction procedures that deliver particularly reproducible results. Further parameters such as tissue-specific cell lines and alternative staining methods will be comparatively tested. The optimized assay will be linked to the analysis of metabolites. A combination assay can become a much more informative and thus ultimately more efficient tool in the development and optimization of medical devices.
CleanControlling Medical GmbH
The project is part of CoHMed and funded by the Federal Ministry of Education and
Research (BMBF) within the program FH-Impuls 2016, FKZ 13FH5E01IA