The Voxel S.A. Radiopharmaceuticals Production Centre was established in December 2011 at the 5th Military Teaching Hospital with Policlinic in Cracow, under the auspices of European Union investment, under the priority axis entitled Investments in innovative undertakings, Measure 4.4 IEOP (Innovative Economy Operational Programme): New investments of high innovative potential for the project entitled: "The implementation of innovative production and service team in the medical services sector." This investment, based on world-class technology, including the opening of one of the most advanced PET-CT-MRI diagnostic imaging centres in the country, represents a milestone in the development of diagnostic imaging and nuclear medicine in Poland. For Polish patients, it means better access to diagnostic tests of the highest quality. With this investment, Cracow became home to the first such PET laboratory in the nation. The second centre of commercial production of radiopharmaceuticals for PET diagnosis in Poland was opened, an extremely important development as it eliminated the need for imports which significantly limited the availability of tests.
In the autumn of 2012, Voxel was GMP-certified and authorised by the Chief Pharmaceutical Inspector to produce fludeoxyglucose (FDG) - the most important radiopharmaceutical used in PET tests. Since then, Voxel has used this product in its five PET centres in Poland. In July 2013, we obtained a permit from the Office for Registration of Medicinal Products to launch a medicinal product made in Cracow, since when - thanks to the contracts we have subsequently entered into - we have supplied FDG to several important nuclear medicine centres in Poland. We have also opened a wholesale outlet of radiopharmaceuticals, and have the appropriate licences to transport them. Thus, we are fully independent as both a manufacturer and supplier, and can supply our radiopharmaceuticals to every customer in our country.
Our centre is the most modern centre producing radiopharmaceuticals for PET in Central Europe. It was established based on technology from GE Healthcare and other world leading manufacturers in the field of nuclear medicine technologies. The compact, modern GE PET trace cyclotron, and three fully automated laboratories for the synthesis of radiopharmaceuticals, ensure reliability and the highest quality of production. The quality control laboratory is equipped with devices of the highest standard. All the essential elements of the apparatus are doubled, which guarantees the possibility of performing the required measurements and tests in case of any complications. Within 25 minutes we have the capability of performing several complex tests, which allows us to release a batch of the product as soon as half an hour after the end of production.
We employ highly qualified specialists with vast experience, working diligently to improve their qualifications through regular training and by attending international conferences. As a medical company with years of experience in the field of diagnostic imaging and nuclear medicine, we have at our disposal the highest quality medical and technical staff. We are happy to share our experience with our partners, as we understand their needs and are able to adapt to them. We guarantee not only to supply the highest quality services, but also to provide support and assistance in organizing and carrying out effective research at diagnostic centres.
Our medicinal product
At our centre, under license from GE Healthcare, we produce SteriPET® (the commercial name of fludeoxyglucose). Production is fully automated, and the parameters are monitored by specialists. Synthesis takes place in the FastLab module using disposable cartridges, making it fully reproducible, fast and highly efficient. Even our competition agrees that this technology is second to none throughout the world. SteriPET is the only FDG radiopharmaceutical available in central Europe sterilised in the final container. The filled vial is sterilised in an autoclave which ensures the biological purity of the product. This is extremely important because the results of microbiological tests are not available until much later, and the medicine must be administered to the patient within 10 hours of manufacture. Our customers can be certain of the sterility of the product.
New opportunitiesWe are able to research and develop the production of other tags and radiopharmaceuticals for PET tests, produced using a cyclotron. We are interested in cooperating with research, clinical and pharmaceutical centres in this area of research.