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Radiopharmaceutical industry: Development prospects

Representatives of regulatory agencies and pharmaceutical market experts talked about prospects for development of the radiopharmaceutical sector in Russia, at the BIOTECHMED forum that recently took place in Sochi. Vladislav Shestakov, Director of the FSU “SID and GP” of the Ministry of Industry and Trade of Russia, took part in the discussion.



At large, Russia’s nuclear industry retains a leadership position in many markets. However, domestic nuclear medicine lags behind the world’s most advanced healthcare systems.

“Now the domestic nuclear medicine, including the production of radiopharmaceuticals, is in dire need of government support”, Vladislav Shestakov, director of the FSI “SID and GP”, noted in his address. “Russia is one of the main producers of raw medical isotopes, of which almost 90% are exported. I am confident that Russia, with a strong raw material base, should expand the range of production of radiopharmaceutical drugs. And after that, we need to reach a new level and meet the challenge of export development, first of all, within the Eurasian Economic Union.”

Director of the FSI “SID and GP” also drew attention to such an important point in radiopharmaceutical production as the design of premises for frontline handling and manufacture of radiopharmaceuticals. For such projects, it is necessary to involve designing engineers who have knowledge of radiopharma, including the layout and requirements for the specifications of dedicated areas of radiopharmaceutical production facilities.

“We have experience in implementing such projects at our Institute”, Vladislav Shestakov said. “Officers of the Good Engineering Practices Division have implemented a joint project with Karpov Institute of Physical Chemistry (Rosatom State Corporation). This is a state-of-the-art pharmaceutical manufacturing facilities of medical isotopes and products on a production floor that covers 25,000 m2 (269,098 sq ft). The experts of our engineering centre devised a conceptual design for radiopharmaceutical production, an analytical and microbiological laboratories with the “hot” and “cold” zones being separated into “clean” and “dirty” ones, and developed ventilation schemes as well as a design for the industrial radioactive waste storage facilities.”