Ural Federal University: University Ready to Produce Radiopharmaceuticals for More than 100 Procedures a Day

The UrFU Innovation and Implementation Center “Cyclotron Center for Nuclear Medicine” is ready to produce the radiopharmaceutical fluorodeoxyglucose (FDG) in sufficient quantity to perform over 100 diagnostic procedures a day. This is enough to cover the need for cancer diagnostics in the Sverdlovsk Region. FDG examination is the most widespread type of diagnostics in the world and in Russia.

“The potential capacity of our center for FDG production is sufficient to provide radiopharmaceuticals for four positron emission tomographs – computer tomography scanners at their maximum load of 30 diagnoses per day on one scanner. For example, the maximum load of one scanner in a two-shift operation mode and a six-day work week is up to 9,000 diagnostics per year, and the average load is up to 6,000 diagnostics per year. In Ekaterinburg, there are currently two PET scanners at the oncology center on Shirokaya Rechka. Four scanners are needed in the Sverdlovsk Region with its population of 4.29 million people to reach the European average,” says Stepan Zyryanov, Director of the UrFU Innovation and Implementation Center “Cyclotron Center for Nuclear Medicine”.

The physical launch of the robotic radiochemical complex for FDG production, trial production of medications, and testing of the quality control laboratory equipment was performed at UrFU back in September-November 2021. Now the university is in the process of obtaining licenses from state agencies (at least five supervisory agencies must be approved). In April the university received the sanitary and epidemiological expertise of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor). The next step is a license from the Federal Service for Environmental, Technological and Nuclear Supervision (Rostekhnadzor). Since the pharmaceutical licensing procedure is extremely complicated and time-consuming, the first locally produced medications might appear in Ekaterinburg hospitals by the end of 2022 or the beginning of 2023. Today, no FDG-based medications are produced in the Sverdlovsk Region; they are delivered daily by air from Ufa.

PET (positron emission tomography) is the imaging of tumors by assessing biochemical activity at the molecular level. This diagnosis is more effective compared to ultrasound, CT scan, and MRI, which assess the dynamics of tumors by changes in their size and structure. PET diagnostics allows detecting early tumor foci starting from a few millimeters in size, assessing their activity and making a plan for further treatment.

90% of all PET diagnostics are done with FDG. However, FDG-based preparations do not detect specific types of cancer pathologies. For their diagnosis, as well as for detection of Parkinson’s disease, congenital hyperinsulism, neuroendocrine tumors, etc., the UrFU is ready to produce other radiopharmaceuticals. For example, preparations based on isotopes of iodine can be produced. They are used both for diagnostics and therapy of oncology, including pediatric oncology. At the same time, such medications can be transported over longer distances. In Russia today, radiopharmaceuticals on the basis of iodine are available only at the Kurchatov Institute (for clinics in Moscow and Moscow region) and the Khlopin Radium Institute V.G. Khlopin Radium Institute (for St. Petersburg medical institutions).

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