A consortium of Austrian research groups from the University of Vienna, MedUni Vienna, and Technikum Wien, in collaboration with DOC Medikus GmbH, has developed an innovative bioanalytical test system for radiopharmaceutical drug candidates. This new method eliminates animal testing, enabling automated, rapid, and highly precise analyses. The research findings were recently published in the Journal of Nuclear Medicine.
Challenges in Radiopharmaceutical Development
New drugs and diagnostic methods should be both safe and readily available. However, the preclinical testing phase often delays progress due to its high resource demands. Developing radioactive marker substances (radiotracers)—used in cancer diagnosis to visualize physiological and pathological processes—requires extensive and costly testing. Traditionally, these tests relied on animal experiments, which not only raise ethical concerns but also frequently yield results that do not translate to the human body.
A Human Cell-Based Alternative
An interdisciplinary research team has introduced a breakthrough solution: a bioanalytical test system that utilizes human cells on a silk matrix to evaluate drug candidates faster, more precisely, and without animal testing.
Innovative Technology: Silk-Based 3D Cell Culture
The patented process integrates chromatographic principles (separating substances based on interactions with a stationary and mobile phase) with a dynamic 3D cell culture.
At its core, the system features biocompatible silk fibroin sponges that serve as an artificial scaffold, immobilizing human cells in a 3D structure. A specialized pump system continuously delivers nutrients, mimicking realistic tissue conditions. Researchers then apply radiopharmaceutical agents and observe their effects in real-time using advanced imaging techniques such as µPET/CT (positron emission tomography/computed tomography). This approach allows for the simultaneous evaluation of radiotracer binding and cellular biochemical processes.
Enhancing Efficiency and Ethical Standards
“With our method, we not only provide an alternative to animal testing but also make the development of new radioactive marker substances significantly more efficient,” said Verena Pichler, first author from the Department of Pharmaceutical Sciences at the University of Vienna. “Our goal is to advance diagnostics and therapy while simultaneously improving ethical standards.”
Practical Benefits and Industry Impact
As reported by medicalxpress, this system enables precise evaluation of radiopharmaceuticals by assessing binding properties, target accuracy, and potential side effects. The use of silk fibroin provides several advantages, including radiation stability and its proven application in cell culture.
By introducing frits (sieve-like partitions) between the sponges, researchers have reduced cell migration, leading to greater reproducibility in test results. Additionally, factors such as radiation dose distribution and nutrient supply to the cells can now be precisely controlled. The team also prioritized automation and standardization to enhance the safety and efficiency of handling radioactive substances.
Aligning with Global Standards
The new method aligns with the 3R principle (reduce, refine, replace) and meets the FDA’s Critical Path Initiative recommendations. This technology represents a major advancement in preclinical radiopharmacy. It reduces reliance on animal testing, accelerates radiopharmaceutical development, and minimizes radiation exposure for personnel.
Setting New Standards in Drug Development
This groundbreaking innovation has the potential to set new standards in radiopharmaceutical research, leading to more sustainable, efficient, and ethical drug development. This technology streamlines preclinical testing and enhances precision. It marks a significant step forward in cancer diagnosis and therapy.