Center for Design and Synthesis of Radiopharmaceuticals for Molecular Targeting CERAD on the Polish Roadmap for Research Infrastructures

Transcription

1 Center for Design and Synthesis of Radiopharmaceuticals for Molecular Targeting CERAD on the Polish Roadmap for Research Infrastructures Renata Mikolajczak National Centre for Nuclear Research, Warsaw, Otowck, Poland

2 MARIA Research Reactor National Centre for Nuclear Research

3 MARIA RESEARCH REACTOR MAIN NUCLEAR FACILITY

4 Maria Research Reactor The high flux research reactor MARIA is a water and beryllium moderated reactor of 30 MW power level; Pool type reactor with pressurized fuel channels containing concentric tube assemblies of fuel elements; Fuel channels are situated in matrix containing beryllium blocks surrounded by graphite reflector: nominal power 30 MW thermal neutron flux density 2.5x10 14 n/cm 2 s moderator H 2 O, beryllium reflector graphite in Al cooling system channel type Operated since Dec. 16, 1974 Expected operation time of reactor: 2030 MARIA RR started with fuel conversion program according to RERTR Initiative (Reduce Enrichment for Research and Test Reactors) is in progress 19.75% / 485 g U-235 per FE / density of 4.8 g/cm 3 The first LEU type FE made by CERCA was loaded to the core on Sep 12

5 V VI IX X XI XII L K J J I I H G F E MARIA RESEARCH REACTOR HORIZONTAL CROSS-SECTION Gamma & neutronography stand REACTOR POOL Channel H7 Boron Neutron Capture Therapy Facility Reactor Facility for Neutron Transmutation Doping of Silicon Channel H6 Channel H5 H4 Channel H3

6 Irradiation of 235 U targets in Maria Research Reactor Due to Mo-99 shortages for nuclear medicine, Maria Research Reactor started the program of irradiatinguranium targets (HEU) in collaboration with COVIDIEN. HEU targets are shipped by road for processing in Mallinckrodt facilities in Petten, the Netherlands: Regulatory issues had to be solved: safety analysis and design of irradiation rig, safety analysis of transport from MRR to reprocessing facility using special transportation container, engineering of irradiation facility & reloading devices,! Irradiation of HEU targets started 1st February 2010

7 Maria Reactor produced radionuclides Nuclide Half-life Target Nuclear reaction Radionuclidic purity [%] Specific activity not less than 133 Ba 10.7 y 132 BaCO 3 n, MBq/mg Ba 134 Cs y 133 CsCO 3 n, MBq/mg Cs 51 Cr 27.7 d Cr met n, GBq/mg Cr 60 Co y Co met n, MBq/mg Co 64 Cu h Cu met n, MBq/mg Cu Eu y Eu 2 O 3 n, MBq/mg Eu 8.60 y 166 Ho h Ho 2 O 3 n, MBq/mg Ho 131 I d TeO 2 n, GBq/mg I (nca) 59 Fe d Fe 2 O % enriched 58 Fe n, MBq/ mg Fe 177 Lu d Lu 2 O % enriched 176 Lu n, GBq/ mg Lu 32 P d S nat n,p TBq/ mg P (nca) 186 Re 3.72 d KReO 4 n, MBq/mg Re 153 Sm d Sm 2 O 3 n, GBq/mg Sm 46 Sc d Sc 2 O 3 n, MBq/mg Sc 110m Ag d Ag met n, MBq/mg Ag 85 Sr d SrCO % enriched 84 Sr n, MBq/mg Sr 35 S d KCl n,p 99.5 nca 160 Tb 72.3 d Tb 2 O 3 n, MBq/mg Tb 113 Sn d Sn met n, MBq/mg Sn 80-99% enriched 112 Sn 170 Tm d Tm 2 O 3 n, MBq/mg Tm 90 Y d Y 2 O 3 n, 99.0 ca 65 Zn d ZnO 98% enriched 64 Zn n, MBq/mg Zn

8 Maria Reactor produced radionuclides Nuclide Half-life Target Nuclear reaction Radionuclidic purity 131 [%] I Specific activity not less than 133 Ba 10.7 y 132 BaCO 3 n, MBq/mg Ba 134 Cs y 133 CsCO 3 n, MBq/mg Cs 51 Cr 27.7 d Cr met n, GBq/mg Cr 60 Co y Co met n, MBq/mg Co 64 Cu h Cu met n, MBq/mg Cu Eu y 177 Lu 153 Sm 59 Fe Eu 2 O 3 n, MBq/mg Eu 8.60 y 166 Ho h Ho 2 O 3 n, MBq/mg Ho 51 Cr 131 I d TeO 2 n, GBq/mg I (nca) 59 Fe d Fe 2 O % enriched 58 Fe n, MBq/ mg Fe 177 Lu d Lu 2 O % enriched 176 Lu n, GBq/ mg Lu 32 P 35 S 32 P d S nat n,p TBq/ mg P (nca) 186 Re 3.72 d KReO 4 n, MBq/mg Re 153 Sm d Sm 2 O 3 n, GBq/mg Sm 46 Sc d Sc 2 O 3 n, MBq/mg Sc 110m Ag d Ag met n, MBq/mg Ag 85 Sr d SrCO % enriched 84 Sr n, MBq/mg Sr 35 S d KCl n,p 99.5 nca 160 Tb 72.3 d Tb 2 O 3 n, MBq/mg Tb 113 Sn d Sn met n, MBq/mg Sn 80-99% enriched 112 Sn 170 Tm d Tm 2 O 3 n, MBq/mg Tm 90 Y d Y 2 O 3 n, 99.0 ca 65 Zn d ZnO 98% enriched 64 Zn n, MBq/mg Zn

9 MARIA Research Reactor National Centre for Nuclear Research

10 Radioisotope Centre Polatom Medical application Research & Development National Centre for Nuclear Research, Radioisotope Centre POLATOM

11 Radioisotope Centre POLATOM Results of our research programs and innovation activities can be directly implemented in the GMP certified production and QC facilities. Supply of high quality radiopharmaceuticals and diagnostic kits for nuclear medicine and important manufacturer of radiochemical products for customers all over the world National Centre for Nuclear Research, Radioisotope Centre POLATOM

12 Radiopharmaceutcals with manufacturing authorisation Quality Assurance System certified: PN-ISO 9001:2001 GMP and GLP

13 99 Mo/ 99m Tc radionuclide generators and kits for 99m Tc labelling Over 30 milion of diagnostic procedures with 99m Tc /year in the world SA VLA HLA STRESS REST

14 Laboratory for Preclinical Research Modern animal facility at POLATOM Well equipped laboratory with systems and cabinets, ensuring high hygienic standard for laboratory animals. Secialized animal models of human cancers can be handled Small animal gamma camera and optical imaging system allow comprehensive in vivo investigation of new tracers. National Centre for Nuclear Research, Radioisotope Centre POLATOM

15 Microbiological laboratory Modern clean-room at POLATOM for sterility testing and other biological assays. National Centre for Nuclear Research, Radioisotope Centre POLATOM

16 TEKTROTYD - first 99m Tc-labelled somatostatin analogue for imaging of GEP-NET tumours 99m Tc 99m Tc - Tektrotyd

17 Świerk Computing Centre 24 M, specialized building ~Pflops, 17 PB disc space Certified for classified data (EU and NATO) Computing for research (GRID)

18 Detectors for NCBJ NCBJ s high-level of competences in: Fast photomultipliers for PET (world expertise in fast timing systems) Fast timing for Time-of-Flight PET Scintillators and photodetectors for PET SiPM arrays in timing and gamma spectrometry with scintillators APD, SDD Detectors for dual modality PET/CT scanners PET detectors in hadron therapy

19 National Centre for Nuclear Research combines basic and applied science Basic science Applied physics Research infrastructure Commercial applications (accelerators, radioisotopes) Reactor physics Material investigations Nuclear energy National Center for Nuclear Research Radioisotope Centre POLATOM

20 CERAD on the Polish Roadmap for Research Infrastructures CERAD Center of Design and Synthesis of Radiopharmaceuticals for Molecular Targeting Radioisotope Imaging of GLP-1 receptor expressing tumors Objective: to improve and expand the research infrastructure located at the National Centre for Nuclear Research towards research programs oriented at the design and pre-clinical evaluation of new drugs carrying the radioactive probe (radiopharmaceuticals) and other multimodality probes, suitable for diagnostic and therapeutic application using biologically active molecules traced at the cellular and molecular level National Center for Nuclear Research Radioisotope Centre POLATOM

21 To utilize the existing potential of NCBJ: Maria Research Reactor 30 MW, neutron flux 3 x n/cm 2 s Wide range of produced radionuclides: 32 P, 99 Mo, 131 I, 177 Lu Material science, neutron irradiation investigations Radioisotope Centre POLATOM Pharmaceutical development and validation Hot-cells for handing radioisotopes Research laboratories Preclinical animal studies Świerk Computing Centre HPC cluster on blade multicore servers, large volume computational capacity Specialized software for in silico computational simulations

22 To expand the potential of NCBJ: 30 MeV cyclotron accelerating protons and alpha particles to 30 MeV and deuterons to 15 mev Specialized laboratories Widdening the range of available radionuclides: 11 C, 13 N, 15 O, 18 F, 22 Na, 44 Sc, 47 Sc, 74 As, 64 Cu, 67 Cu, 67 Ga, 68 Ge, 81 Rb, 82 Sr, 86 Y, 89 Zr, 94m Tc, 99m Tc, 109 Cd, 111 In, 123 I, 124 I, 201 Tl, 211 At, 225 Ac, Novel imaging techniques: Multimodality scanners, Chemical synthesis and Biochemical laboratories,

23 CERAD Research Program design, synthesis and selection of carrier molecules based on computational simulations and pre-clinical studies efficacy and safety evlaution of new targeting molecules pharmaceutical validation m AP PA A PA 24 h P 4 h

24 CERAD - Consortium Coordinator: National Centre for Nuclear Research Consortium members: University of Warsaw Institute of Nuclear Chemistry and Technology in Warsaw National Medicines Institute (NIL), Warsaw Warsaw Medical University (WUM) Jagiellonian University (UJ), Krakow Open for co-operation with international scientific community

25 Poland

26 Nuclear Medicine in Poland 70 nuclear medicine departments all over the country PET-CT PET-MRI scanners (24) scanners (2)

27 Production of medical isotopes - cyclotrons 9 medical cyclotrons, 11 Mev and above K160 at HIL

28 Production of medical isotopes Maria Research Reactor medical cyclotrons, 11 Mev and above K160 at HIL Maria Research Reactor

29 CERAD 30 MeV cyclotron medical cyclotrons, 11 Mev and above K160 at HIL Maria Research Reactor 30 MeV cyclotron

30 Swierk Computing Centre Maria Research Reactor Cyclotrons Strong collaboration network in the country Imaging technology (detectors and scanners) Radiopharmaceutical manufacture Research facilities Nuclear Medicine Pre-clinical testing

31 National and international cooperations Narodowe Centrum Badań i Rozwoju European Research Area Network funded by the European Commission under FP7 National Centre for Nuclear Research Radioisotope Centre POLATOM