Preclinical pharmacological research and the clinical approval of drugs have traditionally been heavily dependent on animal testing. However, this practice poses significant ethical and economic challenges for drug developers and manufacturers. A key problem in preclinical drug testing is the limited transferability of animal test results to humans; 92% of drugs that are successfully tested in animal experiments fail in clinical trials. This is also evident in the preclinical studies for the characterization of radiopharmaceuticals conducted at the Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Institute for Radiopharmaceutical Cancer Research, in cooperation with ROTOP Pharmaka GmbH.
In the area of quality assurance for already approved drugs, the continuous testing of production batches in animal experiments poses a major challenge. The legal framework for conducting such tests is already very restrictive, and further tightening of regulations is to be expected. In addition, there are only a few approved special laboratories for these test methods in Europe, none of which are located in Germany. In view of the rapidly growing market for radiopharmaceuticals, there is therefore a strong economic interest in the development of alternative test methods that can be carried out locally, thus opening up new growth opportunities.
Microphysiological systems (MPS), which enable the cultivation of cells, organoids, or tissue sections, offer a sustainable alternative for overcoming the challenges involved in the approval and quality assurance of pharmaceuticals. Fraunhofer IWS is a leading player in the development and prototyping of such MPS, which replicate the function of human organs and tissues in vitro, thereby optimizing preclinical testing, disease modeling, and approaches to personalized medicine. The industrial implementation of these systems requires scalable, multi-stage manufacturing of complex plastic components. This is where Sander Kunststofftechnik comes in, having developed innovative production processes for manufacturing complex plastic systems for medical technology for over twenty years.
The “RadioSecure” project pursues the overarching goal of developing forward-looking microsystems and associated test protocols for the preclinical development and batch testing of radiopharmaceuticals, enabling seamless market introduction. With the aim of being a pioneer in this dynamically growing market, we want to anchor our innovations sustainably through close cooperation with key partners from research and industry within the Saxon economic and scientific ecosystem, especially around the Nuklid® radiopharmaceutical cluster in Dresden.
Fraunhofer Institute for Material and Beam Technology IWS