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2013|14 Annual Report Fraunhofer IGB

CELL AND TISSUE ENGINEERING The focus of the Cell and Tissue Engineering Department is the development of functional in vitro 3D tissue models from isolated primary human cells under GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice) guidelines for applications in regenerative medicine, tissue engineering, medical device development and cell-based assays for toxicol- ogy. We develop biomaterials and biofunctionalized micro- or nano-structured material surfaces for the isolation of pure cell cultures from human tissues, particularly adult stem cells. The physiological culture of 3D tissue models is achieved with spe- cially developed PC-controlled bioreactor systems which mimic the biomechanical environment of a specific organ or tissue. The sterility and quality control for cell-based transplants is a complex process, which typically requires multiple transplants for testing. Therefore, we have established non-invasive test methods, Raman spectroscopy and multi-photon micros- copy, for the pre-implantation analysis of tissue engineered constructs, which drastically reduces production and quality assurance cost, while increasing the safety of the transplanted constructs. We have developed a two-layer 3D human skin equivalent that has been patented (EP 1 290 145B1) and certified for medical devices biocompatibility tests (DIN ISO 10993-5). The skin model can be extended to include cell types, such as melanocytes or tumor cells. Furthermore, the skin model is a cost-effective human-based preanimal test system for pen- etration and distribution tests of chemicals under EU REACH regulations. Further questions in regard to cell differentiation and death, as well as tumor development and metastasis, can be studied with our model. Recently, vascular structures have been integrated into the skin model and the automated pro- duction of the avascular skin model could be achieved. Another main focus is the further characterization of our 3D intestinal test system and the development of new intestinal disease models. Our accredited 2D intestinal test system with integrated colon carcinoma cells (Caco-2) is used for transport studies to validate the permeability of potential drug candi- dates and other compounds. Additionally, we are developing methods for the creation of cardiovascular implants, regenerative therapies and 3D test systems. Due to the lack of regenerative potential in the adult cardiovascular system, we primarily work with human embry- onic and induced-pluripotent stem cells, as well as complex bioreactor systems. Competencies Isolation and culture of primary cells from different tissues and species in accordance with current GLP or GMP regu- lations ¡¡ Biomaterial using tissue-specific extracellular matrix proteins ¡¡ Micro- or nano-structured material surfaces ¡¡ Skin and skin tumors, as well as intestinal and cardio- vascular tissues Method development for constructing 3D organotypic cell cultures for in vitro test models or tissue reconstruction ¡¡ Biological and biologic matrices ¡¡ Tissue-specific, computer-driven bioreactors Establishing methods for the non-destructive characteriza- tion of cells and tissues by means of Raman spectroscopy and multiphoton microscopy ADMET (absorption, distribution, metabolism, excretion and toxicity) are pharmacokinetic and toxicological properties that must be tested during drug development. Using our test COMPETENCES 56

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