Rosatom announced recently that two production lines at its modern radiopharmaceutical manufacturing facility under construction in the Kaluga region have entered trial production. The facility was built in accordance with the Eurasian Economic Union's international Good Manufacturing Practice (GMP) standards and is equipped with high-level production equipment to supply the market with safe, quality-controlled radiopharmaceuticals.

It is reported that enterprises under Rosatom currently produce more than a dozen registered diagnostic and therapeutic radiopharmaceuticals, involving isotopes such as iodine-123, iodine-131, technetium-99m, and samarium-153. The new factory's production plan is based on the demand for radioisotope products from Russian medical institutions through 2030. The company stated that by the end of this decade, the project is expected to substantially meet the related needs of Russia's healthcare system, supporting approximately 1.5 million radiopharmaceutical diagnostic and therapeutic procedures annually.

The facility has been conducting commissioning work since early August and has completed the relevant tasks of the trial production phase, with products tested to meet required specifications and quality standards. According to plan, the factory is expected to reach its design capacity in 2028. A company technical executive stated that, focusing on high-demand radionuclides, the enterprise is transitioning from raw material production to high-tech drug manufacturing that meets GMP requirements, establishing a complete cycle from isotope preparation to finished pharmaceuticals to strengthen quality control and shorten the time to market for domestic new products.

Among the production lines launched in this round, the radium-223-based radiopharmaceutical is primarily used for cancer treatment, particularly for bone metastasis-related therapy. The nuclide acts on metastatic lesions, exerting anti-tumor effects and alleviating pain, thereby helping to improve patients' quality of life.

The other production line will be used for actinium-225-based radiopharmaceutical production. As an alpha-particle emitter, actinium-225 can bind to specific molecules to achieve targeted delivery to cancer cells. Its emitted alpha particles can damage tumor cell DNA and induce cell death, thereby being used to eliminate lesions, including micrometastases.

The factory employs Russian-made automated synthesis modules capable of producing at least 100 vials of radiopharmaceuticals per shift. The automated system helps improve batch-to-batch consistency, reduce human error, ensure the sterility of finished products, and allows the production process to be adjusted according to the synthesis requirements of different radiopharmaceuticals.

In addition, the factory has constructed a radioactive waste storage and treatment system. Solid radioactive waste is loaded into specially designed containers via dedicated robotic arms, with operators completing remote control from a control room to enhance safety during waste storage and processing.

The project aligns with Russia's healthcare-related infrastructure development plans. As radiopharmaceutical diagnostic and treatment infrastructure advances at medical institutions, the radiopharmaceuticals produced at the new factory will provide supporting supply for clinical diagnostics and treatment.

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