A private nuclear pharmacy unit at the Institute of Nuclear Medicine of AO Meditsina in Khimki, near Moscow, has begun regular production of the radiopharmaceutical Fluorodeoxyglucose (¹⁸F-FDG), labelled with the short-lived isotope Fluorine-18. This product is a cornerstone for diagnosing cancer.
The company stated that its advanced equipment allows it to control the entire technological cycle in-house, from obtaining the radioactive isotope to producing the final, ready-to-use drug.
The manufacturing process involves four key stages: the synthesis of the radiopharmaceutical, rigorous quality control (including checks for radiochemical purity, sterility, and apyrogenicity), prompt delivery to medical facilities, and strict adherence to radiation safety protocols.
Grigory Roytberg, President of AO Meditsina and an academician of the Russian Academy of Sciences, said the launch of domestic production addresses the growing demand for radiopharmaceuticals, enhances diagnostic accuracy, and increases availability of advanced treatments. The message states that more cancer patients can now get prompt and quality treatment through the CHI system.
The ¹⁸F-FDG produced at the facility is used for Positron Emission Tomography-Computed Tomography (PET/CT) scans at its own Institute of Nuclear Medicine and at the oncology center of the Meditsina clinic in Moscow.
Fluorine-18 is a highly sought-after but extremely unstable radionuclide with a short half-life of approximately 110 minutes. Its effective use is only feasible with production facilities located close to diagnostic centres. Until now, many medical institutions in Russia had to procure ¹⁸F-FDG from abroad or distant production sites, which significantly limited availability and drove up the cost of medical examinations.
In the near future, the Khimki site plans to begin production of other in-demand radiopharmaceuticals, including ¹⁸F-PSMA, ⁶⁸Ga-PSMA, ¹⁷⁷Lu-PSMA, ¹⁷⁷Lu-DOTA-TATE, and ²²⁵Ac. These agents are used for the highly precise diagnosis and treatment of oncological and neuroendocrine diseases. These approaches are founded on the principles of theranostics. GxP News wrote about theranostics in one of its recent publications.
