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Lutetium-177 isotope

Product
Developers: SPb Isotope
Branches: Pharmaceutics, medicine, health care

2020: Delivery to Italy

On October 22, 2020 it became known that JSC In/about Izotop (the enterprise of Rosatom state corporation, the supplier of isotope products) performed delivery of a radioisotope of lutetium-177 to Italy, to one of medical institutions of the region Apulia — consortium of hospitals and the Policlinico di Bari universities.

Rosatom for the first time delivered lutetium-177 in medical institution of Europe. Photo source: Twitter

The purpose — lutetium-177 quality evaluation and also confirmation of stability of a supply chain and its compliance to the European standards and the provisions Evratoma.

Delivery became possible thanks to the memorandum of understanding signed in November, 2019 between the companies of Rosatom - JSC In/about Izotop and JSC Rusatom Healthcare - and administration of the region Apulia (Italy).

The radioisotope of lutetias-177 for October, 2020 is one of the most perspective in therapy of a number of oncological diseases, such as: neuroendocrine tumors, prostate cancer, cancer of a thyroid gland, etc.

The report of Policlinico di Bari prepared based on quality evaluation confirms that the lutetium-177 delivered to JSC In/about Izotop meets all necessary requirements of the European legislation and a pharmacopeia (in particular, EU GMP) and can be used for further production of radiopharmaceutical.

On October 21, 2020 in Consortium of hospitals and the Policlinico di Bari universities there passed the round table within which the Russian and Italian sides discussed cooperation results in 2020 and also plans for the future. The governor of Apulia Michele Emiglijano, the CEO of the regional strategic agency of health care and social protection Giovanni Gorgoni, the head of Consortium of hospitals and the Policlinico di Bari universities of Bari Giovanni Milyore, the CEO of JSC Rusatom Healthcare Alexander Shibanov, the CEO of JSC In/about Izotop Maxim Kushnarev, etc. took part in a round table.

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In 2020 the pandemic connected with COVID-19 showed to the whole world importance of the international cooperation in the field of health care clearly. We consider that active cooperation of the countries having own competences of the development area of technologies of nuclear medicine in the long term will allow to create the most effective instruments of fight against oncology,
commented Alexander Shibanov.
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It should be noted that the level of development of nuclear medicine in Italy — one of the highest in the world what does perspective cooperation with Italy even more relevant regarding exchange of experience and possible carrying out joint surveys in the future.

Despite an epidemiological situation in the world, the logistics of lutetium-177 is implemented along initially planned route. Acquired based on Institute of reactor materials (Zarechny, Sverdlovsk region) of lutetias-177, it was sent to the address of the European platform for the purpose of final processing of a product and release according to requirements of the international standard GMP (Good Manufacturing Practice) then it is brought to Policlinico di Bari. Thus, lutetium-177 overcame more than 5000 km, having reached final destination.

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Supply of lutetium-177 to clinic of Bari for the purpose of quality evaluation — an example of commitment of the parties to the international agenda in the field of sustainable development. First, the quality of initial material has a direct impact on a production process of radiopharmaceutical and, as a result, on its efficiency. Secondly, stabilization of a supply chain of the vital products to which including medical isotopes and radiopharmaceuticals belong is an unconditional priority, so far as concerns life of patients,
noted Maxim Kushnarev.
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For October, 2020 the line of raw isotopes of medical appointment made by the enterprises of an isotope complex of Rosatom is supplied to the European market only to manufacturing companies of radiopharmaceuticals which independently sell further finished goods in the territory of Europe. Supply of lutetium-177 to Italy opens for Rosatom of an opportunity in the field of development of competences in production and expansion of geography of deliveries of radio nuclide products for nuclear medicine[1].

Notes