New drugs and substances are required to be tested for quality, safety and efficacy before market authorization. Due to the lack of equivalent alternative methods, animal experiments are an important standard instrument in drug research. Due to species-specific differences; however, animal experiments are not always suitable for the authorization of new substances or the adaptation of new therapies to humans.
Therefore, the Fraunhofer IGB has been increasingly engaged in the development of alternative human test systems that mimic the complex characteristics of the body and permit the investigation of materials according to the ADMET criteria (absorption, distribution, metabolism, excretion and toxicity). These test systems are based on in vitro cultured human primary cells, cell lines, induced-pluripotent stem cells or adult stem cells. In order to ensure cell functionality in vitro, culture conditions are created that are similar to the natural microenvironment of the cell in the body. For specific applications, co-cultures with other cell types and custom-designed carrier substrates must be employed.
The Department of Cell and Tissue Engineering is specialized in constructing human three-dimensional (3D) tissues. The 3D nature of the scaffolds considerably affect parameters such as metabolic activity, viability, division, morphology and differentiation status and thus, ultimately, the function of the tissue as a test model.