1. SID & GP
MINPROMTORG OF RUSSIA
Corporate
Communication
Center
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
September 2019, Kaliningrad

2. VVR-c nuclear reactor complex
Thermal power - 15 MW.
The maximum neutron flux density is 6 · 1013 n / 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. Federal executive body including for operation at nuclear facility
Licenses and Certificates regulating activities
Federal executive body
Q-ty
including for operation at nuclear facility
State Corporation Rosatom 1
Minpromtorg of Russia 2 -
Ministry of Health of Russia 6
Roszdravnadzor 3
FMBA of Russia 30
Rostekhnadzor 9
Rospotrebnadzor
Rosnedra
Russian Federal Security Service
General partner: Strategic partners: Official partners: Regional partners:

4. Medical products VVR-c reactor
Radioactive molybdenum-99 in the form of a solution of sodium molybdate Na2MoO4
Technetium-99m Generators
("Sodium pertechnetate, 99mTc from the generator")
Diagnostics of the thyroid and salivary glands, brain
Radioactive iodine-131 without carrier in the form of a sodium iodide solution
"Sodium iodide, 131I in isotonic solution"
Diagnostics and therapy of the thyroid gland
"Sodium iodide, 131I”
Diagnostics of the thyroid gland
"Sodium O-Iodohippurate, 131I"
Kidney diagnostics
VVR-c reactor
Carbon-14
"Urecaps, 14С"
Diagnostics of the gastrointestinal tract:
peptic ulcers and malignant tumors
Samarium-153
"Samarium, 153Sm oxabifor"
Palliative therapy of bone metastases
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-131 run 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-153 run per week
Capacity ratio
General partner: Strategic partners: Official partners: Regional partners:

6. Product supply Current Test supplies conducted Possibilities
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7. Partners of JSC “L. Ya. Karpov Institute of Physical Chemistry”
JSC “SSC NRRI” - supply of 99Мо and 131I;
JSC “IRM” - irradiation with 152Sm;
JSC “SSC RF PPE” - 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 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 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. Radiopharmaceuticals are ready for clinical trials.
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 million rubles, VBS 34.1 million rubles)
State Contract No. 14.N 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.N 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.N 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. Porous ceramic microparticles with yttrium-90 / holmium-166
Promising R&D
Microparticles with yttrium-90 / holmium-166 for radioembolization and radio synovectomy
Photo of 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 microns;
 the specific gravity of the microsphere - not more than 3.6 g / cm3;
 volumetric activity Bq / 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!
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