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MINPROMTORG OF RUSSIA

MINPROMTORG OF RUSSIA. SID & GP. IV ALL-RUSSIA GMP CONFERENCE. Experience of JSC “L.Ya . Karpov Institute of Physical Chemistry” in production of radiopharmaceuticals and raw isotopes for the Russian market and cross border sales. Corporate Communication Center.

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MINPROMTORG OF RUSSIA

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  1. MINPROMTORG OF RUSSIA SID & GP IV ALL-RUSSIA GMP CONFERENCE Experience of JSC “L.Ya. KarpovInstitute of Physical Chemistry” in production of radiopharmaceuticals and raw isotopes for the Russian market and cross border sales Corporate Communication Center September 2019, Kaliningrad

  2. VVR-c nuclear reactor complex • Thermal power - 15 MW. • The maximum neutron flux density is 6 · 1013n / cm2 · s. • The number of experimental channels is 31, of which 22 are vertical and 9 are horizontal. • The reactor has 9 hot chambers, 5 heavy chemical boxes, 6 canyons equipped with 30 remote manipulators. General partner: Strategic partners: Official partners: Regional partners:

  3. Licenses and Certificates regulating activities General partner: Strategic partners: Official partners: Regional partners:

  4. Medical products • VVR-c reactor General partner: Strategic partners: Official partners: Regional partners:

  5. Production Development in 2016-2018 Production capacity for Мо-99 run per week Production capacity for I-131run per week • Focus targets: • Improving technological processes in order to increase the yield of the product, improve its quality, reduce radioactive waste; • Expansion of production capabilities for the manufacturing of products; • Launch of new products in order to expand the geography of supplies and increase the company's revenue. Capacity ratio Capacity ratio Production capacity for Sm-153run per week Capacity ratio General partner: Strategic partners: Official partners: Regional partners:

  6. Product supply Current Test suppliesconducted Possibilities General partner: Strategic partners: Official partners: Regional partners:

  7. Partners of JSC “L. Ya. KarpovInstitute of Physical Chemistry” • JSC “SSC NRRI” - supply of 99Моand 131I; • JSC “IRM” - irradiation with 152Sm; • JSC “SSC RFPPE” - production of technetium-99m generators; • The branch of JSC "Concern Rosenergoatom" LNPP "- irradiation of tellurium targets. General partner: Strategic partners: Official partners: Regional partners:

  8. Restoring the manufacturer's monograph for the production of the radiopharmaceutical "Iodcaps, 131I" • Manufacturer's monograph 42-0018-4816-036 for the production of the radiopharmaceutical "Iodkaps, 131I" was valid until May 25, 2009. • Currently, this manufacturer's monograph has lost its effect. • In order to ensure the production of the radiopharmaceutical "Iodkaps, 131I " the following is necessary: • a new registration of the radiopharmaceutical in accordance with the Federal Law “On the Circulation of Medicines” dated 12.04.2010 N 61-FZ; • creation of a new site for its production. • (The cost of equipment is more than 10 million rubles.) General partner: Strategic partners: Official partners: Regional partners:

  9. R&D completed Federal Target Program “Development of the pharmaceutical and medical industry of the Russian Federation for the period till 2020 and beyond” (Pharma 2020) (BS 102.2 million rubles, VBS 34.1 million rubles) State Contract No. 14.N08.12.0054 dated October 21, 2015 on the topic: "Preclinical studies of a radiopharmaceutical based on samarium-153 in a heat-sensitive carrier for local radiation therapy of tumors" State Contract No. 14.N08.12.0028 dated March 17, 2014 on the topic: “Preclinical studies of an innovative therapeutic radiopharmaceutical based on meta-iodobenzylguanidine labeled with iodine-131 for the treatment of adrenal pheochromocytoma” State Contract No. 14.N08.12.0106 dated September 20, 2016 on the topic: “Preclinical studies of a radiopharmaceutical based on samarium-153 in a polymer carrier for radiation therapy of metastatic spinal tumors” • All developed radiopharmaceuticals are subject to intellectual property rights. • Radiopharmaceuticals are ready for clinical trials. General partner: Strategic partners: Official partners: Regional partners:

  10. Promising R&D Microparticles with yttrium-90 / holmium-166 for radioembolization and radio synovectomy Photoof microspheres with yttrium-90 in comparison with human hair Microspheres insertion through catheter Porous ceramic microparticles with yttrium-90 / holmium-166 • the proposed mechanism of action is the intra-arterial injection of a medical device into the hepatic artery in the form of an aqueous suspension of ceramic microparticles with yttrium-90 or holmium-166 radioisotopes included in the composition and allows localization of microparticles within the vasculature of the tumors and exposure of surrounding neoplasms with β particles, while ensuring a cytostatic effect, blocking blood flow to the tissues of the tumor, depriving them of oxygen and nutrition; - with the local introduction of a radiopharmaceutical into the joint, the synovial membrane of the joint is affected, which leads to the formation of its superficial fibrosis and the persistent suppression of inflammation. •  localization of the radionuclide in the vicinity of the tumor - at least 90% of the administered dose; •  microsphere size - 25-40 microns; •  the specific gravity of the microsphere - not more than 3.6 g / cm3; •  volumetric activity - 107-108Bq / ml; •  radiochemical purity - not less than 97%; •  radionuclide purity - not less than 99.9%; •  safety - the predicted ratio of efficacy and toxicity should be positive. General partner: Strategic partners: Official partners: Regional partners:

  11. Thank you for your attention! General partner: Strategic partners: Official partners: Regional partners:

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