Rusatom Healthcare, part of state nuclear corporation Rosatom, will build Russia’s first radiopharmaceutical plant to meet global GMP good manufacturing practice standards. The new production facility will be in Obninsk at the site of LYa Karpov Scientific Research Institute of Physics & Chemistry (NIFKhl) and will produce drugs for targeted cancer therapy. The design of pharmaceutical production will be carried out by the Central Design and Technological Institute. Pre-design work is planned to be completed this year, for commissioning in 2024 production in early 2025.
NIFKhI was selected because it specialises in isotope research and the production of radiopharmaceuticals. The first cobalt gamma plants and the WWR-Ts research reactor began operation there in the 1960s. Secondly, NIFKhI has the entire infrastructure, including storage facilities for liquid and solid radioactive waste. The institute is also engaged in clinical trials and drug registration and has basic licences from Rostechnadzor. Registration is a lengthy procedure, and for the drug to go on sale by 2025, clinical trials need to be started before the construction of the plant itself. Finally, the proximity of the Obninsk site to Moscow airports will significantly simplify the transportation of products.
By 2030, Rusatom Healthcare will open 12 radionuclide therapy departments, where radiopharaceuticals produced at the new plant will be used. In the first years, production will be focused on the domestic market, only 35% of the products will be supplied abroad. By 2030, the share of exports will grow to 85%.
With the new production, the range of NIFKhI's radiopharmaceutical products will expand: to include generators for technetium-99m and RFP with iodine-131, samarium-153, preparations based on lutetium-177, actinium-225, radium-223 will be added. Currently these are produced only abroad, and most of them are not registered in Russia.
“These drugs are focused on an effective and sometimes uncontested solution to the problems of cancer therapy,” says Alexander Shibanov, general director of Rusatom Healthcare. “While most of the traditional methods of treatment can be compared to shooting a cannon at sparrows - the entire body is exposed to a powerful toxic effect - targeted therapy with RP is a sniper, point effect on the affected cells. The drug molecule sees disease markers and delivers the active substance to the affected cells without affecting healthy cells. "