Status of Mo-99 Supply and New Developments

Transcription

1 Status of Mo-99 Supply and New Developments Joao Alberto Osso Junior Head, Radioisotope Products and Radiation Technology Section 06 October 2015 International Atomic Energy Agency

2 The Mandate The Agency shall seek to accelerate and enlarge the contribution of atomic energy to peace, health and prosperity throughout the world. It shall ensure, so far as it is able, that assistance provided by it or at its request or under its supervision or control is not used in such a way as to further any military purpose. 2

3 Contents Mo-99: importance, supply structure and RPRT/ RR programmes : HEU minimization : stability of supply of Mo-99 : Production of Tc-99m by Cyclotrons : upcoming activities 3

4 Mo-99 Supply of Mo-99 Tc-99m is the most important radioisotope for diagnosis in Nuclear Medicine Ideal decay properties: SPECT Easy to label kits (> 20 kits) Mo-99/Tc-99m generators Fission produced Mo-99 4

5 99m Tc radiopharmaceuticals Kits available for preparing 99m Tc-radiopharmaceuticals to get info on Most organs anatomy and abnormalities Most systems/dynamic functional abnormalities ~ 30 M studies /year; work-horse of diagnostic nuclear medicine Cardiology; Oncology Main areas

6 Demand of Mo-99 10,000 6-day Ci per week (world) 5,000 6-day Ci per week (USA) 6

7 Fission Production flow of Mo-99/Tc-99m Centralized Radiopharmacy Source: 7

8 Supply of Mo-99 crisis Supply problems since 2007 Main shortage in 2009 Ageing of Reactors 2016: Nordion will cease production: Extension of NRU operations until March 2018 as back-up capacity 8

9 Current irradiators of U targets Source: 9

10 Current processors of irradiated U targets Source: 10

11 Current irradiaton capacity and demand The annual growth rate of Mo-99 in mature markets (North America, Europe, Japan and the Republic of Korea) is assumed to be 0.5%, and in emerging markets 5% ORC: Outage Reserve Capacity Source: 11

12 Current processing capacity and demand Source: 12

13 1. Mo-99 production routes: Nuclear reactors The supply of medical radioisotopes-review of potential Molybdenum-99/Technetium- 99m production technologies. Nuclear Energy Agency-OECD November 2010

14 1. Mo-99 production routes: Accelerators The supply of medical radioisotopes-review of potential Molybdenum-99/Technetium- 99m production technologies. Nuclear Energy Agency-OECD November 2010

15 Potental new irradiators 15 Source:

16 Potential new processors 16

17 Potential new producers Australia 17

18 Potential new producers Rep. Korea 18

19 Potential new producers - Argentina 19

20 Potential new producers - Brazil 20

21 Potential new producers USA SHINE 21

22 Potential new producers USA SHINE 22

23 Potential new producers USA NorthStar 23

24 Potential new producers USA NorthStar 24

25 Potential new producers USA NorthStar 25

26 Potential new producers USA NorthStar 26

27 New high capacity adsorber PermaFix 27

28 Organization for 99 Mo Work Office of the Director General Department of Management Department of Nuclear Science and Applications Department of Nuclear Energy Department of Technical Cooperation Department of Nuclear Safety and Security Department of Safeguards Division of Physical and Chemical Sciences Division of Nuclear Fuel Cycle and Waste Technology RR section Radioisotope Products and Radiation Technology Section Research Reactor Section 28

29 Radioisotopes and Radiopharmaceuticals Availing Medical Radioisotopes (Mo-99/Tc-99m; Ge-68/Ga-68; Y-90; Cu-64 etc.) Development of Radiopharmaceuticals (Lu-177-anti-CD20) Establishing production facilities GMP/ regulatory compliant; training Updating radiopharmaceutical monographs for the International Pharmacopeia WHO Preparation of syllabus for the Radiopharmacy courses in recognized Universities and e-learning modules for education and training in Radiopharmacy 29

30 Priorities for 99 Mo HEU Minimization Transition of 99 Mo production away from the use of highly enriched uranium (HEU) Stability of Supply Diversification of supply and movement to full cost recovery to ensure the global demand is met 30

31 Activities on 99 Mo Collaboration with the OECD-NEA participates in the OECD-NEA s High Level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) Outreach of HLG-MR principles to Member States 31

32 Priorities for 99 Mo HEU Minimization Transition of 99 Mo production away from the use of highly enriched uranium (HEU) 32

33 4. Conversion of Major Mo-99 Producers to LEU Supported by US DOE-NNSA and the Government of Norway Series of meetings (since 2010) for key stakeholders to review progress, exchange information and explore opportunities for mutually beneficial collaboration Last meeting: 6 February 2015 As the major producers are progressing in their conversion activities, this group will redirect its focus on addressing future activities that will assist producers following initial conversion 33

34 4. Current processors of irradiated U targets Source: 34

35 Priorities for 99 Mo Stability of Supply Diversification of supply and movement to full cost recovery to ensure the global demand is met 35

36 Role of RPRT with RR Stability of supply of Mo-99 in MSs Indigenous production using non-heu targets: 235 U(n,f) 99 Mo reaction 98 Mo(n,γ) 99 Mo reaction 100 Mo(p,2n) 99m Tc reaction Cyclotron Small scale for local use Regulatory aspects New alternatives to Tc-99m To assist MSs to improve operational performance / reliability of an ageing fleet of RRs 36

37 Activities on 99 Mo Small-scale, non-heu production of 99 Mo A coordinated research project (CRP) on Developing Techniques for Small Scale Indigenous Molybdenum-99 Production Using LEU Fission or Neutron Activation. CRP Member States LEU fission or (n,γ) reacion Technical Report Series No. 478, Feasibility of Producing Molybdenum-99 on a Small Scale Using Fission of Low Enriched Uranium or Neutron Activation of Natural Molybdenum (Jan 15) 37

38 3. Non-HEU Mo-99 production EURASIA Coalition work Reactors in Eastern Europe and former Soviet states cooperating to produce low specific activity 99Mo via neutron capture of 98Mo (launched in 2008) Nuclear Energy Series No. NF-T-5-4: Non-HEU Production Technologies for 99 Mo and 99m Tc Published pdf 38

39 Small-scale, non-heu 99 Mo production Interregional Technical Cooperation Project INT1056 started in 2013 PUI funds Supporting the Global Deployment of Mo-99 Production Capacity for Nuclear Medicine Applications without the Use of Highly Enriched Uranium (HEU) Aimed at assisting small-scale, national-level producers in setting up their production capability; NOT aimed at creating commercial producers Will rely on LEU fission or n,gamma-based production Open to any Member States wishing to receive advice and assistance 39

40 Small-scale, non-heu 99 Mo production Production infrastructure fact-finding missions were completed to Mexico, Morocco, Peru, Poland, and Romania. Similar missions were conducted in Egypt (2010) and Malaysia (2011) 40

41 Training course Board of Radiation and Isotope Technology, BRIT Mumbai, India from 22 to 27 June participants 12 countries Member States: Algeria Bangladesh India Indonesia Kazakhstan Libya Malaysia Peru Romania Thailand Uzbekstan Vietnam 41

42 Training course Lectures, demonstrations and visits: Production and supply of Mo-99 All the aspects related to (n,gamma) production Generators with low specific Mo-99 (gel generator) Solvent extraction of Tc-99m Hot cells Regulatory issues Lecturers: Experts from India Ms. Yelena Chakrova, Head of Radiochemistry and Isotope Production Center, Institute of Nuclear Physics AEC MINT, Kazakhstan Joao Osso - 42

43 Production of 99m Tc in Cyclotron CRP - Accelerator-based Alternatives to Non-HEU production of Mo-99/Tc-99m ( ): 100 Mo(p,x) PETtrace TR19 CP42 43 A. Celler, X. Hou, F. Bénard, T. Ruth, Phys. Med. Biol. 2011, 56, 5469

44 Cyclotron Production of Tc-99m 99m Tc p 100 Mo 101 Tc n n 100 Mo(p,2n) 99m Tc 44

45 Cyclotron Production of Tc-99m 45

46 Demonstrating Proof of Concept Courtesy : Tom Ruth, Triumf, Canada 46

47 5. Main Issues 11 Participating countries Target preparation (withstand heat generated by the beam) Radionuclidic separation Mo/ 99m Tc: fast and high yield Recovery of the target: enriched and high cost (supplier) Radionuclidic impurity: choose optimum beam energy, time of irradiation and decay time Delivery of 99m Tc 47

48 5. Radionuclidic Impurities 100,9x Mo(p,2n) 9x Tc series 99g Tc 97g Tc 95g Tc 94g Tc 93g Tc 48

49 5. Conclusions of the CRP TRIUMF announcement on January 5, hours irradiation time, 24 MeV, 450 µa 34 Ci of Tc-99m Clinical trials in Canada early 2015 Last RCM: June 2015 (Vienna) 49

50 Potential new producers Canada 50

51 Role of RPRT Alternatives for Tc-99m: Tl-201, Rb-82, F- 18-Fluoride, Ga-68, Cu-64 CRPs on: F-18 radiopharmaceuticals Ga-68 radiopharmaceuticals Production of Cu-64 and I

52 New Activities CRP on Sharing and Developing Protocols to Further Minimize Radioactive Gaseous Releases to the Environment in the Manufacture of Medical Radioisotopes, as Good Manufacturing Practice (2-28 August 2015) TM on New Ways of Producing 99m Tc and 99m Tc Generators (14-18 March 2016) TM on regulatory aspects of radiopharmaceutical production (07-11 December 2015) Support to TC projects (Regional LA 2016) 52

53 Conferences The 1st International Conference on Applications of Radiation Sciences and Technologies ICARST 2017 will be held in April 2017 at HQ.

54 धन यव द International Atomic Energy Agency