Automatable cultivation steps
Because the patented (Patent No. EP 1 290 145B1) three-dimensional (3D) skin model test system developed at Fraunhofer IGB is a well established system, it was perfectly suited as a first standard model for an automated system.
The first step in the development of automated process in tissue engineering was the analysis and understanding of all steps, from the skin biopsy to a 3D skin model, and to be able to translate them into machine processes and environments.
Within the project, the production of a synthetic collagen replacement of biocompatible and biodegradable polymers was also investigated. Another task was the development of a bioreactor for automated cell culture with a functionalized membrane for the expansion of the cells.
Validation as an alternative to animal experiments
In order for an in vitro test system to be accepted by the European Centre for the Validation of Alternative Methods (ECVAM), it must be shown that the test system is sufficiently sensitive, specific and reproducible to describe the toxicological properties of the tested substance. Manually produced epidermis models are currently being used in accordance with ECVAM guidelines as validated tests to replace animal experiments. The main objective now is therefore the validation of the first in vitro irritation skin test system (epidermis model) created from a fully automated system. We are benefitting from the existing data from previous validation studies and the existing experiences of the ECVAM with this test system. This should allow us to validate the test system within the shortest possible time period while preparing the models for commercial use.