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2015|16 Annual Report Fraunhofer IGB

TRANSLATIONAL CENTER “REGENERATIVE THERAPIES”, WÜRZBURG BRANCH In the light of increasing life expectancy, a greater health awareness, and growing cost pressure in the health system, regenerative medicine and the development of innovative agents will play a crucial role. The Translational Center Würz- burg develops medical products and therapeutic methods on the basis of innovative agents and cell-based therapies. The competence fields of the Translational enter are focused on quickly implementing the transfer of new materials or cell- based regenerative therapies for individualized patient care into medicine. By establishing an interdisciplinary network in Würzburg, the whole value chain can be covered – from the develop- ment of biomaterials and the construction and production of bioreactors to in vitro test systems (as an alternative to animal testing), up to therapy accompanying diagnostics (theranos- tics) and the approval of cell-based implants and (biologized) medical products. Furthermore, there exists a long-standing expertise in admission-relevant animal models as well as the implementation of (pre-)clinical studies. Innovative products for therapeutical application on human beings are liable to complex regulatory requirements. We ad- vise and support you in the planning and implementation of pre-clinical and clinical studies. Together with the Center for Clinical Research (Zentrale für Klinische Studien, ZKS) at the University Hospital of Würzburg, we are developing strategies which insure the implementation of pre-clinical and clinical inspection in accordance with internationally recognized qual- ity standards (GLP, GCP). One unique characteristic of the Würzburg IGB team is the vascularized scaffold BioVaSc® , used for the production of implants, which can be connected to the circulatory system during implantation. The complex tissue models were reg- istered as a brand in 2015. This includes models of human skin (SkinVaSc-TERM® ), intestines (GutVaSc-TERM® ), trachea (TraVaSc-TERM® ), and lung (LunVaSc-TERM® ). The BioVaSc® technology has been transferred to decellularize other organs such as the lung and the heart to isolate tissue-specific pro- teins. The ECM proteins obtained can be blended directly with polymers to produce support structures for implants or they can be used for the modification and biologi ation of implant surfaces. In the Translational Center Würzburg, we are developing hu- man 3D in vitro test systems with methods of tissue engineer- ing, which can be used as an alternative to animal tests, since data of animal studies often do not reflect the conditions of human organisms. In so doing, we focus, among other things, on human barriers such as skin, airways, and the digestive tract, and depict both healthy as well as diseased tissue with our tissue models. With the tissue models, we simulate the interaction of medical products, e.g. stents, with the hu- man body, in order to optimize the surfaces of the implants. Furthermore, the test systems are used for risk assessment of biological substances and synthetic materials in the field of oncology and infection studies, particularly with human obli- gate pathogens. The new research training group “3D Infect” is being established in cooperation with the Würzburg branch of Fraunhofer IGB and the University of Würzburg. 52 COMPETENCES