Rosatom First Delivered the Radioisotope Lutetium-177 to a Medical Facility in Europe

27 October 2020

GMP News

Isotope JSC, official distributor of isotope products manufactured by ROSATOM’s enterprises, successfully delivered lutetium-177 produced according to EU GMP standards to Nuclear Medicine Department of Policlinico of Bari (Apulia, Italy) for quality evaluation. The activity was implemented within the scope of the Healthcare Memorandum of Understanding signed between Apulia Region and ROSATOM in November 2019.

At present, lutetium-177 is considered to be one of the most promising agent in oncology therapy. Radiopharmaceuticals based on lutetium-177 have already demonstrated excellent therapeutic performance in several applications, as prostate cancer and gastroenteropancreatic neuroendocrine tumors treatment. Policlinico of Bari verified that the entire supply chain of lutetium-177 conformed to the international quality & safety standards.

Policlinico of Bari provided Russian side with the report that shows that the entire supply chain of lutetium-177 starting from the raw material production at INM JSC facility in Russia to the delivery to the end-user in Apulia fully conformed to the international quality & safety standards. Produced in adherence with the EU GMP lutetium-177 is of high quality and can serve a substance for further radiopharmaceutical production guaranteeing safety for patients.

The international cooperation between ROSATOM and Apulia Region demonstrates a new collaborative approach in R&D for solutions in nuclear medicine and exchanging knowledge. “Being one of the world’s largest producer of isotope products, this year COVID-19 pandemic has clearly shown the importance of international cooperation in the field of healthcare, including sustainability of medical isotopes and radiopharmaceuticals supply chain. We believe that active collaboration between countries that have their own unique competences in the development of nuclear medicine technologies in the nearest future will help to create the new effective tools to fight cancer”, commented Alexander Shibanov, Director General of Rusatom Healthcare JSC (company of ROSATOM, the integrator in the field of nuclear medicine and radiation technologies).

ROSATOM is among the top three largest producers of bulk lutetium-177 in the world, supplying this product on a regular basis to pharma companies in Europe and Asia. Delivery of Lu-177 to the Italian hospital is ‘the foundation stone’ laid for ROSATOM in its long-term strategy to become a viable member of the world radiopharmaceutical market to improve patients’ quality of life globally.

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