Tissue engineers use interdisciplinary techniques to produce complex implants from the body’s own cells, stem cell sources and biocompatible substrate materials. Such implants minimize the risk of rejection and offer long-term physiological regeneration of impairments. Unlike conventional implants, this novel approach of advanced therapy medicinal products (ATMPs) also makes use of the body’s own self-healing capacities in order to exploit cellular mechanisms supporting a partial or complete restoration of impaired organ functions. Before the regulatory authorities can accept an ATMP for clinical trials, they require proof that such products comply with GMP (good manufacturing practice) requirements.
Before approval, developers must test new drugs and substances for their quality, efficacy and safety. In the absence of equivalent alternatives, the regulatory authorities prescribe animal experiments as mandatory in preclinical drug research. Due to species-specific differences, however, the results of animal experiments are not always transferable to humans. Hence there is a growing demand for alternative human test systems (tissue models) that reflect, for example, the complex properties of the human body and enable studies according to ADMET criteria (absorption, distribution, metabolism, and excretion and toxicity). In order to ensure proper 3D tissue maturation, developers must create in vitro culture conditions that correspond to the natural micro-environment of the cells in the body. Here, they use sophisticated bioreactor devices to ensure dynamic culture and physiological shear stress conditions. In addition, they may also make use of automation strategies (e.g. robot technologies) to achieve a high degree of standardization during tissue production and downstream testing.
The Fraunhofer seminar on Tissue engineering will provide a compact review of the basics of tissue engineering – in terms of both the biology and materials science. The two-day seminar will also offer an insight into practical applications at Fraunhofer ISC, ranging from personalized test systems to the development and approval of cell-based therapies.