Cytocompatibility and Biocompatibility Assays are essential tools in determining the safety associated with the use of a particular Biomaterial/Medical Devices for clinical application in Humans but also, in Animals. Following the standards imposed by ISO 10993-6: 2016, in a first phase, the different types of cells are grown in contact with the Biomaterial / Medical Device to be tested in order to determine the positive or negative influences that this association may have at levels of cell viability and its metabolic performance.
Later, and proving good results of Cytocompatibility, the same Biomaterials/Medical Devices are subject to Biocompatibility tests, in which they are applied at subcutaneous level in adequate animal models of increasing complexity (rat and sheep) and shall be collected in specific timepoints to determine the presence of local reaction phenomena (foreign body reactions, fibrosis and inflammatory reactions) and/or systemic (inflammatory reactions or signs of organic rejection in visceral organs).
Biosckin, Molecular and Cell therapies, S.A. provides hands-on services for pre-clinical testing of cell-based therapies and biomaterials/medical devices, using certified facilities and high-qualified human resources.
For more information about conducting Cytocompatibility and Biocompatibility trials, please contact us.
Prices on request.