The Technical Customer Service of the FMBA of Russia is seeking a contractor to carry out the reconstruction of the 4th building of the Burnasyan Federal Medical Biophysical Center in Moscow for the deployment of a cyclotron radiochemical complex (CRCC). It will be a specialized facility for the production of gamma- and positron-emitting radionuclides using the TR-24 cyclotron, as well as for the production of radioactive raw materials, and the synthesis of radiopharmaceutical precursors and radiopharmaceuticals derived from them.
Burnasyan Federal Medical Biophysical Center (FMBC) conducts fundamental, applied, and exploratory scientific research in the fields of radiation, nuclear medicine, radiopharmaceuticals, and radiobiology. For the industrial production of radioprotectors, radiomigators, and radionuclide preparations being developed at FMBC, a dedicated production site was required, as specified in the accompanying procurement documentation.
It also states that the contractor is responsible for developing design documentation based on the medical and technological assignment, conducting engineering surveys, overseeing reconstruction works, and supplying the necessary equipment. The work will be carried out under a state defense order and financed from the federal budget.
The term of the contract is until December 20, 2030. The reconstruction is planned in three stages. In 2025, 160 million rubles will be allocated to the contractor. No funding is planned for 2026, and 70 million rubles will be provided in 2027. The rest of the amount will be distributed from 2028 to 2030.
According to the medical and technological assignment, the radionuclides developed at the CRCC will be used for the development and manufacture of approved and experimental radiopharmaceuticals for their use in the clinical department of the Burnasyan Federal Medical Biophysical Center in the concept of the theranostic approach of nuclear medicine.
The document states that the additionally developed radionuclides and radioactive precursors will enable the practical application of a unique range of labeled molecular tracers. These tracers will be used to evaluate various biological processes in vivo and support the research and development of new methodological approaches for treating different diseases.
It is planned that the reconstruction of the CRCC, combined with the experience of the FMBC, will enable the creation of a unique scientific and production facility. This facility will focus on the development, manufacturing, and clinical application of drugs within the framework of radiation safety and high-tech medical care, using nuclear medicine methods.
The tasks of the CRCC will include the production of internationally approved and innovative radiopharmaceuticals, the development of radionuclides for third-party institutions within the FMBA, including specialized institutions of the Rosatom State Corporation. Additionally, it will focus on implementing groundbreaking research and development in the field of obtaining radioactive precursors for nuclear medicine.
The main tasks of the new complex include the development of novel radiopharmaceuticals for diagnostic and therapeutic applications, as well as the targeted production of these innovative drugs. This will be based on monoclonal antibodies and their fragments, aligning with the principles of personalized medicine. CRCC specialists will conduct research and development on the creation and biological evaluation of molecular tracers suitable for studying and modeling the distribution of technogenic radionuclides in the human body during emergencies. This includes assessing their short- and long-term effects, as well as utilizing these tracers for functional diagnostics of the body in cases of radiation-related pathology.
The medical and technological assignment specifies the structural composition of the CRCC. The facility will include a cyclotron, which requires the construction of a bunker, control rooms, target preparation areas, a repair shop, and infrastructure for power and water supply. Additionally, it will feature a radionuclide production unit with dedicated rooms for the isolation of radionuclides and the production of radioactive raw materials. The center’s structure will also encompass a radiopharmaceutical manufacturing unit, including facilities for producing radiopharmaceuticals for PET, single-photon emission computed tomography, and radionuclide therapy; a reagent warehouse; laboratories for precursor synthesis, acceptance testing, and packaging; and staff offices.
Additionally, it will feature an R&D unit with an analytical laboratory, solutions preparation and water treatment facilities, temporary storage areas for materials and reagents, and laboratories dedicated to molecular visualization. The product quality unit will include a room for physical and chemical analytical measurements, storage for archival samples, and a microbiological laboratory. Auxiliary areas will comprise staff offices, temporary storage rooms for finished products, materials, and reagents.
The walls, floor, and ceiling of the complex must be constructed from radiation-resistant materials that do not generate dust. The production process will involve the consistent daily synthesis of radionuclides via a nuclear reaction that takes place during the irradiation of a non-radioactive target material with a proton beam produced by a charged particle accelerator.
CRCC plans to manufacture several promising radiopharmaceuticals with fluorine-18, including ¹⁸F-NaF solution for intravenous administration, ¹⁸F-fluorodeoxyglucose (FDG), ¹⁸F-fluoro-PSMA-1007, and several other compounds.
In March 2025, Russian President Vladimir Putin signed a decree prepared by the FMBA regarding amendments to the list of strategic enterprises and joint-stock companies. According to the decree, the Federal Center for the Design and Development of Nuclear Medicine Facilities (FC PROYAM) was incorporated into the Burnasyan Federal Medical Biophysical Center. The decision was made with the aim of “developing modern radiobiology and ensuring the Russian Federation’s supply of radioprotectors, radiomigators, and radionuclide preparations.”
