ÚJV Řež spearheading the revolution in quality control of radiopharmaceuticals

In late November, the installation of the first Trasis‘ beta-unit, QC1 Core, referred to as the „lab in a cube“ was completed. The apparatus, sized similarly to a standard tabletop PC, is able to conduct the majority of analyses required for quality control in manufacturing radiopharmaceuticals and batch release. Typically, these processes would require multiple machines occupying a considerably larger space. The equipment is able, using single-use cartridges, to perform quality control of several radioactive pharmaceuticals. Moreover,  its integrated shielding and automated functions reduce personnel radiation exposure and minimize the risk of sample contamination.

ÚJV Řež received the QC1 instrument, marking it as the first radiopharmaceutical manufacturer worldwide to do so. This milestone is based on longstanding collaboration with engineers and developers from Trasis SA, the current market leader in PET radiopharmaceuticals development and production technologies. The testing and validation phase of the QC1 system in Brno will take about one year and include both equipment and process validation.

„If this automated system meets the declared expectations and qualities during the testing, it would bring huge benefits to us at several levels. The compact size of the equipment would optimize our constrained workspace and potentially expand our product offerings. In the future,  it may even fully replace some of our machines. Last but not least, the miniaturization and automation of quality testing would mean lower radiation exposition for our employees,“ says Jan Adam, Ph.D., Research and Development Manager of the Radiopharmaceuticals Division of ÚJV Řež, describing the expected advantages of the system.

 

However, the new technology must demonstrate its reliability through comprehensive testing under real manufacturing conditions. Batch quality control will be conducted parallelly using standard technologies alongside the QC1. If the results align with validated methods compliant with Good Manufacturing Practice over the long term, the Radiopharmaceuticals Division of ÚJV Řež aims to implement this system also in its two other centres in Praha and Řež.

 

The QC1 system can be also controlled remotely, it can simultaneously conduct up to 5 different types of radiopharmaceutical analysis. It generates a comprehensive and standardized report automatically within 25 minutes. The replaceable single-use cartridges contain all necessary substances and materials for batches quality control, and the testing includes 10 fundamental tests. "The QC1 testing project signifies a substantial augmentation of our team's responsibilities in Brno, supplementing their routine tasks devoted to maintaining a steadfast and dependable supply of PET radiopharmaceuticals to the Czech market. However, at ÚJV Řež, we consider embracing innovation as a fundamental element of our long-term success strategy. Taking on this additional workload not only positions us as pioneers but also as active contributors to the advancement of innovations," concludes Jan Adam.

 

A safe production and sufficient portfolio of supplied radiopharmaceuticals for Czech patients is an important obligation of the Division of Radiopharmaceuticals of ÚJV Řež.