Biocompatibility and Research Data Management Unit (BC & RDM Unit)
(Sandra Johnen and Peter Walter)
Objective and Aim: The aim is to describe the safety profile of new materials and structures in vitro in contact to living cells but also in vivo in contact to ocular tissue and cells.
Approach: Direct and indirect cell viability tests will be performed according to the standard ISO 10993 “biological evaluation of medicinal devices”, part 5 (tests for in vitro cytotoxicity) supplemented by cytotoxicity tests using R28 cells as retinal precursor cells indicating more specifically retinal biocompatibility. The behavior of RPE cells is also used as an indicator of retinal toxicity or tolerance. Structures that pass the in vitro biocompatibility testing will be further analyzed within animal studies using appropriate mouse or rabbit models. Corresponding proposals to conduct the animal experiments will be prepared in accordance with the German Animal Welfare Law and have to be approved by the Institute for Laboratory Animal Science (University Hospital RWTH Aachen) and the LANUV (Landesamt für Natur, Umwelt und Verbraucherschutz NRW).