Meduni Vienna, a consortium funded by the Austrian research group at the University of Vienna, and Technikum Wien and its partner Doc Medikus GmbH, have developed an innovative bioanalytical testing system for radiopharmaceutical candidates for cancer diagnosis and treatment. No animal testing is required, allowing for automated, fast and highly accurate analysis. The new methods have been presented in detail in the well-known journal of nuclear medicine.
New drugs and diagnostic methods should be safe and ideally available quickly, but the preclinical trial stage, in particular, often slowing rapid progress due to the high levels of resources needed. The development of radioactive marker materials (“radioforms”) in particular can see physiological and pathological processes within the body, making them suitable for use in, for example, cancer diagnosis. However, these not only moral controversy, but often provide inability to migrate to the human body. The interdisciplinary research team from the University of Vienna, the University of Applied Sciences Technikum Wien, Meduni Vienna and Doc Medikus GmbH have developed innovative solutions. Bioanalytical testing system that uses human cells on a silk matrix to test active materials under realistic conditions – faster, more accurate, activated without animal testing.
Flow Ideas
The already patented process combines the principles of chromatography (separation of materials based on static and mobile phase interactions) with dynamic 3D cell culture. At the heart of the process is a stationary phase made of biocompatible silk fibroin sponge, which acts as an artificial scaffold for fixing human cells to three-dimensional structures. Special pump systems continuously supply cells with nutrients and simulate realistic conditions for human tissue, whereas radiopharmaceuticals are applied and observed in real time using imaging techniques (µPET/CT, positron emission tomography/computed tomography). This allows for parallel evaluation of radio-type binding and cell biochemical processes. Verena Pichler, first author of the Department of Pharmaceutical Sciences at the University of Vienna, explained: “Our methods can not only create alternatives to animal testing, but also make the development of new radioactive marker materials more efficient. They can also take diagnosis and treatment to new levels and improve ethical standards at the same time.”
Related to practice
This new system will test the accurate assessment of the binding properties of radioactive marker materials, allowing for target accuracy and possible side effects. The use of silk fibroin offers considerable advantages due to radiation stability and proven applications in cell culture. Introducing frits (sieve-like partitions) between the sponges reduces cell migration and improves the reproducibility of the results. Therefore, important factors such as radiation dose distribution and nutrient supply to cells can be accurately controlled. Special attention has been paid to automation and standardization of the processes to make the processing of radioactive materials safe and efficient. The new method follows the recommendations of the 3R principles (“reduction, refinement, exchange”) and the FDA’s key pass initiative. It could significantly reduce animal testing, accelerate the development of radiopharmaceuticals, and minimize radiation exposure to personnel. This groundbreaking technology could set new standards for preclinical radiopharmacies for more sustainable and efficient drug development.
The spherical project to develop an innovative 3D cell culture system was funded by the Austrian Research Promotion Agency (FFG) as part of the Bridge Project.
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