Construction of the Rosatom radiopharmaceuticals plant for 9 billion rubles began in Obninsk

2023: Start of construction of the plant in Obninsk

The construction of the Rosatom plant for the production of isotope medical products has started in Obninsk. This was announced on January 20, 2023 by Zdrav.Expert representatives of Rusatom Healthcare. It was planned to invest at least 9 billion rubles in the project.

Centralization of the most complete range of services in a single Rosatom circuit will reduce costs at each stage of production, which will reduce the cost of radiopharmaceuticals for residents of Russia. The placement of production in Obninsk ensures the prompt supply of radiopharmaceuticals to medical institutions throughout the country and the world. For this, there is its own special car fleet and a developed aviation hub.

Ceremony of laying the foundation of the plant in Obninsk
Ha photo (from left to right): Rosatom CEO Alexei Likhachev, Minister Health Russian Federation Mikhail Murashko, Governor of the Kaluga Region Vladislav Shapsha, Deputy Minister of Industry and Trade of the Russian Federation Vasily Shpak

"Nuclear medicine technologies are advanced methods for the diagnosis and treatment of cancer and cardiovascular diseases. The construction of Europe's largest radiopharmaceutical plant in our country is ROSATOM's timely response to the growing need of Russian healthcare for high-tech medical care. The Ministry supports the development of the infrastructure for the production of radiopharmaceuticals and the provision of medical services using nuclear medicine and radiation therapy technologies, which will increase the availability of this type of services for residents of our country, "said the Minister of Health of the Russian Federation Mikhail Murashko.

As of the beginning of 2023, Rosatom's radioisotope medical products in the Russian Federation allow for about one million diagnostic and therapeutic procedures annually. At the same time, the need for radiopharmaceuticals remains extremely high. With the opening of the plant in Obninsk, the state corporation expects to ensure the technological sovereignty of Russia in the production of radiopharmaceuticals.

As the Governor of the Kaluzhskaya Region Vladislav Shapsha emphasized, the project is socially significant, since the plant's products will help preserve the life and health of thousands of people. With the opening of the plant in the Kaluga region, new highly qualified jobs will appear. The region provides all the necessary support to Rosatom in the implementation of this project, and also conducts close cooperation on a number of other projects, the governor added.

In particular, it is assumed that in 2025 the 21 production line of the plant will allow the production of radiopharmaceutical products for the diagnosis and therapy of a wide range of socially significant diseases, including inoperable metastatic forms of cancer. The plant will be built in accordance with the global GMP standard, which is a guarantee of the quality, safety of the production and use of dosage forms.

Construction of the Rosatom radiopharmaceuticals plant began in Obninsk

In the very near future, a special investment contract 2.0 will be signed for the implementation of an investment project for the development and implementation of a technology for the production of radiopharmaceutical medicines in accordance with the European GMP Drug Production and Quality Control Rules. SPIK will be concluded between the Joint-Stock Company "Research Institute of Physics and Chemistry named after L.Ya. Karpov," the Ministry of Industry and Trade of Russia and the Government of the Kaluga Region. This will allow the company to receive all the necessary measures of state support, "said Vasily Shpak, Deputy Minister of Industry and Trade of the Russian Federation.

Rosatom radiopharmaceuticals will be used by specialists in the field nuclear medicine for the treatment of patients diagnosed with neuroendocrine tumors, myeloid diseases,,, prostate cancer kidneys bone tissues, salivary glands,, brain tumors soloid tumors, neuroblastoma,,,,,, lung cancer,, ovaries,,,,, non-Hodgkin bladder breast skin liver pancreas intestines thyroid gland lymphomas and many other nosologies.

According to the general director of Rosatom Alexei Likhachev, the state corporation has extensive experience in creating drugs and equipment for nuclear medicine, while Rosatom has sufficient competencies to become one of the leaders in the development of high-tech medical care services for Russian citizens.

On the part of the state, we see a powerful demand for the formation of domestic technologies in this area. Rosatom is ready to fully meet the needs of Russian doctors and patients in radiopharmaceuticals and help people from other countries maintain and strengthen health. I am sure that the GMP plant will give an impetus for the development of nuclear medicine and the radiopharmaceutical industry in Russia, "concluded Alexey Likhachev.

2021: Obtaining a positive opinion from the Glavgosexpertiza of Russia

On December 30, 2021, the division Rusatom Healthcare"" accumulating the expertise of the State Corporation Rosatom"" in the region health care received a positive opinion of the FAA "" Glavgosexpertiza of Russia for design and estimate documentation and the results of engineering surveys for the object "Creation of modern pharmaceutical production of isotope products medical of destination at the site. JSC "NIFHI named after L. Ya. Karpova"

The facility will be implemented in accordance with international GMP (Good Manufacturing Practice) standards. With the opening of the plant, ROSATOM will change the disposition of Russia in the international market for nuclear medicine. Production on the basis of NIFHI JSC named after L. Ya. Karpov will become a world production enterprise producing radiopharmaceuticals according to the expanded nomenclature.

Within the framework of the state examination, the reliability of the estimated cost of the facility was confirmed. The volume of investments in the project will be at least 9 billion rubles. The positive conclusion of the FAU "Glavgosexpertiza of Russia" will allow you to start construction of the facility in 2022.

The implementation of the project was a timely response of ROSATOM to the growing need of Russian and world healthcare for radiopharmaceuticals, which are used to provide high-tech medical care to patients with oncological, rheumatological, endocrinological and cardiological diseases.

According to the World Health Organization for 2020, the annual number of detected cases of cancer is growing - in the world 19.3 million, in Russia 591 thousand people. Diagnosis using radiopharmaceuticals makes it possible to identify diseases in several tens of millions of people around the world and start therapy in time, which also implies the use of isotope products. In the future, therapeutic procedures with radiopharmaceuticals will be able to help hundreds of thousands of people a year.

As of December 2021, Rosatom provides radiopharmaceuticals to more than 180 medical institutions in the Russian Federation.

Pharmaceutical production of isotope medical products will be implemented on the basis of JSC NIFHI named after L. Ya. Karpov in the city of Obninsk, which is historically a center for the production of radiopharmaceuticals and active pharmaceutical substances for radionuclide diagnostics and therapy in the Russian Federation. The placement of production in the Kaluga Region is also due to convenient localization to promptly ensure the supply of radiopharmaceuticals to medical institutions of the country using its own fleet of special vehicles and the developed logistics zone of the Moscow aviation hub.

{{quote 'author = said Natalia Komarova, General Director of JSC "Rusatom Healthcare." |

For Rusatom Healthcare, the construction of a radiopharmaceutical production in accordance with international GMP standards is another step towards creating a market-specific medical ecosystem, the goal of which is to increase the availability of vital medical technologies for a large range of patients in Russia and abroad. Centralizing the most comprehensive range of services in a single circuit will reduce costs at each stage of production, which will reduce the cost of radiopharmaceuticals for the inhabitants of our country. The plant will be built taking into account the most current technologies that ensure compliance with the maximum requirements for production safety,}}

The plant will produce a large range of radiopharmaceuticals for internal and external consumption and active pharmaceutical substances, including the most popular products based on iodine-131, samaria-153, molybdenum-99. The plant will also present promising radiopharmaceutical drugs based on lutetium-177, actinium-225 and radium-223.

The planned site on the territory of NIFHI JSC named after L. Ya. Karpov is planned to accommodate the production building and the trestle of the heating network. It is also planned to work on the construction of asphalt concrete driveways and pedestrian zones.^[1]

JSC "Rusatom Healthcare" in cooperation with the leading universities of the country already in December 2021 implements joint educational programs.

2020: Design in Obninsk production of radiopharmaceuticals

On July 8, 2020 Zdrav.Expert , it became known that "" Rusatom Healthcare(integrator in the field of radiation technologies for medicine industries and in the contour of the State Corporation "") Rosatom began the first phase of the project to create modern production radiopharmaceuticals (FPM) in accordance with international requirements for the organization of production and quality control of medicines - GMP (good manufacturing practice). The designer of modern pharmaceutical productions isotope medical products is. TsPTI Central Design and Technology Institute(enterprise) TVEL has begun designing a plant of radiopharmaceuticals.

Rusatom Healthcare will build a plant of radiopharmaceuticals in Obninsk

According to the agreement concluded between the two companies, CPTI will develop pre-design documentation, including the justification of investments (OBIN), and conduct design and survey work. The plant is planned to be built at the site of NIFHI named after L.Ya. Karpov in Obninsk (Kaluga region). The launch is scheduled for 2024.

The future radiopharmaceutical plant will begin to produce targeted radiopharmaceuticals based on such promising isotopes as lutetium-177, actinium-225 and radium-223. These drugs are focused on solving the problems of diagnosis and therapy of cancer, - said Alexander Shibanov, General Director of Rusatom Healthcare JSC. - If most traditional methods of treatment can be compared to shooting a gun at sparrows, when the whole body is subjected to a powerful toxic effect, then targeted therapy using FPM is a "sniper," point effect directly on the affected cells. The drug molecule "sees" certain markers of the disease and delivers the active substance to the affected cells without affecting the healthy ones.

As noted by Mikhail Tarasov, Director General of CPT JSC, within the framework of the project to create a CPT radiopharmaceuticals plant, it is necessary to prepare technological solutions, determine the final cost of the facility and undergo an OBIN examination at Rosatom State Corporation. The next stages include design and survey work, development of design estimates and detailed design documentation. CPTI shall support the results upon receipt of a positive state expert opinion on the design documentation and the results of engineering surveys^[2].

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