Two manufacturing lines have been commissioned for pilot production at a modern radiopharmaceutical plant that Rosatom is building in the Kaluga Region in accordance with the EAEU international GMP standards (GMP– Good Manufacturing Practice, EAEU–the Eurasian Economic Union). This launch event, held on August 25, was attended by more than 30 representatives of federal, regional, industry, and expert media organizations.
“At present, Rosatom enterprises manufacture more than ten registered pharmaceuticals for diagnostic and therapeutic purposes, based on iodine-123, iodine-131, technetium-99m, and samarium-153 isotopes. The new plant's production program has been developed in close cooperation with the Ministry of Health of the Russian Federation, given the demands of healthcare organizations for radioisotope products until 2030. We will be able to meet virtually all of the country’s healthcare demands, estimated to reach approximately 1.5 mln procedures by the end of the decade. “As a manufacturer, Rosatom creates a reliable raw material and technological base, allowing healthcare organizations to provide radionuclide therapy and diagnostics to hundreds of thousands of patients a year,” informed Pavel Zaitsev, Director General of Rosatom Science JSC (Managing Company of Rosatom's Scientific Division).
Yuri Lemekhov, Technical Director of Rosatom Science JSC (Managing Company of Rosatom's Scientific Division), who opened the event, noted that start-up and commissioning works had been underway at the plant since early August and would be completed with the manufacture of test batches of products, as well as testing to ensure compliance with all requirements and quality standards. The plant is scheduled to reach its design capacity in 2028.
“As for the most in-demand radionuclides, Rosatom enterprises will have to switch from producing raw materials to manufacturing high-tech pharmaceutical products in full compliance with GMP requirements. A complete production cycle — from isotope production to the manufacture of finished products — will not only replace imports but also ensure full quality control and reduce the time required to market new domestic products. And this guarantees the stable functioning of the healthcare system and plants the seed for further technological development in the field of radiopharmaceuticals,” Yuri Lemekhov mentioned.
Vladislav Golovin, Head of the
GMP Manufacturing Complex, explained to media representatives the operating
principles of the production line for radiopharmaceuticals based on radium-223.
This radionuclide is used to treat cancer, primarily in cases of bone
metastases. It destroys metastases, provides an antitumor effect, and
alleviates pain, enabling patients to stop using analgesic therapy, which
significantly improves the quality of life.
Gleb Loktev, Head of the New Products and Technologies Department, explained how the plant would manufacture radiopharmaceuticals based on actinium-225. This radionuclide holds a special place among alpha emitters due to its nuclear-physical properties and ability to binding with molecules for targeted delivery. Actinium-225 is attached to a special molecule which delivers the isotope to cancer cells; the alpha particles damage the DNA of tumor cells and cause them to die. This allows physicians to destroy all abnormal foci, including micrometastases.
“Our manufacturing lines are equipped with Russian-made automated synthesis modules. Their key feature and the main difference from other products in the market is the ability to simultaneously synthesize large quantities of radiopharmaceuticals. Our manufacturing line is designed to manufacture at least 100 vials of radiopharmaceuticals per work shift. Owing to automation, we can ensure the reproducibility of each batch, mitigate the human factor, guarantee the sterility of finished products, and modify synthesis algorithms to develop promising radiopharmaceuticals under conditions that meet GMP requirements,” Gleb Loktev explained.
The delegation was also shown a high-tech system for storing and managing radioactive waste. Ivan Sotnikov, Deputy Technical Director of Rosatom Science JSC, has explained that waste is loaded into special containers in the solid radioactive waste (SRW) storage facilities using a special robotic manipulator controlled by an operator from the control room. This ensures the absolutely safe storage and handling of waste materials.
Rosatom Scientific Division
conducts innovative fundamental and applied research for the development of
nuclear and non-nuclear technologies (including in the field of closing the
nuclear fuel cycle, thermonuclear fusion, nuclear medicine); creates science-intensive
technologies both for nuclear medicine and other industries. The division
comprises 13 research institutes and commercial organizations, including JSC
Research Institute of Technical Physics and Automation (NIIITFA), the V. G.
Khlopin Radium Institute JSC and others. These organizations are equipped with
advanced research infrastructure as well as their own pilot production
facilities, enabling the full innovation cycle—from fundamental research and
engineering development to prototype production. Most of the division's
research and development activities are carried out within the framework of the
Unified Industry Thematic Plan. Its responsibilities also include testing,
development of high-tech medical equipment, and creation of advanced structural
materials. In addition, projects are underway to commercialize promising
high-tech solutions.
The new plant's construction is
closely linked to implementing national healthcare projects: the infrastructure
for radionuclide diagnostics and therapy being established in the country's
healthcare organizations will enable clinics to use products from the new
facility.
The government and specialized agencies are working on the planned upgrade of domestic healthcare capacities, ensuring full sovereignty of our country in this field. As a partner of the state in increasing the life expectancy and improving the quality of life of the country's population, Rosatom is increasing the production of a wide range of medical equipment and radiopharmaceuticals, developing an import-independent system of medical assistance to Russian citizens in the diagnosis and treatment of socially significant diseases.
