Scientists from Khlopin Radium Institute JSC (part of the scientific division of Rosatom) have manufactured and put into operation a pilot sorbent synthesis plant for the production of a new type of gallium-68 generators. The work was performed within the framework of the implementation of the Unified Industry Thematic Plan (UITP) of Rosatom.
A radiopharmaceutical based on gallium-68 is used for the most accurate diagnosis of neuroendocrine tumors, myocardial perfusion, and prostate cancer. Generators of the Radium Institute with improved sorbent synthesis technology will meet the best world standards. The uniqueness of the method lies in the use of gel-spherification technology to obtain a sorbent based on titanium dioxide, which will allow the synthesis of a radiopharmaceutical directly from the contents of a generator, reducing the number of production operations in clinics.
The project is able to completely meet the needs of the domestic and foreign pharmaceutical markets, increase the effectiveness and availability of the pharmaceutical for consumers.
“In addition to diagnostics, the radiopharmaceutical based on gallium-68 can be used to treat oncological and dynamic diseases of the body. The radionuclide has greater contrast and resolution for visualizing oncology and physiological processes compared to currently used isotopes. The scientific and technology base we have built and the flexibility of the process will allow us to increase the competitiveness of existing generators, as well as create the next generation of generators,” commented Stepan Danilov, Project Manager of Khlopin Radium Institute JSC.
This year, scientists plan to begin life tests of experimental generators.
“According to its characteristics, this type of generator will be the most efficient of those made in the Russian Federation and will become one of the world leaders. Upon completion of R&D, we are planning to implement a project to create a manufacture of germanium-68/gallium-68 generators, which will become part of a cyclotron complex being built at the Radium Institute site. The manufacture of generators within the framework of this project will combine the entire process chain: from irradiation of targets for the production of germanium-68 isotope to production of the final product,” noted Konstantin Vergazov, Director General of Khlopin Radium Institute JSC.
Gallium-68 has a very short half-life of only 68 minutes, which makes it difficult to transport. Therefore, it is obtained from germanium-68 directly in a clinic. Germanium-68 has a half-life of 271 days, allowing it to be easily delivered to clinics as a generator and used as a source of gallium-68 for at least one year. Every year, more than 100 thousand PET procedures are performed with gallium-68 around the world.
The UITP (Unified Industry Thematic Plan) is a general set of R&D aimed at developing priority areas of scientific and technology development of Rosatom. The majority of scientific research and development is carried out within the framework of the UITP.
For more than 30 years, Khlopin Radium Institute JSC has been providing the North-West region with radiopharmaceuticals of its own production. Clinics in St. Petersburg perform more than 10,000 diagnostic procedures annually using radiopharmaceuticals from the Institute. Now the enterprise is working on creating innovative technologies and expanding the line of diagnostic and therapeutic pharmaceuticals.
The government and relevant authorities are working on a planned update of the capacity of domestic healthcare and ensuring of the full sovereignty of our country in this area. As a partner of the state in increasing the length and quality of life of the country’s population, Rosatom is increasing the production of a wide range of medical equipment, radiopharmaceuticals, and creating a completely import-independent system for providing medical care to citizens of Russia in the diagnosis and treatment of diseases.