IAEA assistance in RI production and supply: 99 Mo case

Transcription

1 IAEA assistance in RI production and supply: 99 Mo case Joao Alberto Osso Junior Head, Radioisotope Products and Radiation Technology Section NAPC/NA/IAEA

2 The IAEA 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 IAEA Organization RPRT Section Office of the Director General Department of Management Department of Nuclear Energy Department of Nuclear Science and Applications Department of Technical Cooperation Department of Nuclear Safety and Security Department of Safeguards Division of Physical and Chemical Sciences Radioisotope Products and Radiation Technology Section

4 Nuclear Sciences & Applications Contribute to Promoting food security and sustainable agricultural development (FOOD & AGRICULTURE, NAFA) Improving the diagnosis and treatment of diseases and nutrition (HUMAN HEALTH, NAHU)) Providing knowledge & expertise for science & industry (RADIOISOTOPE PRODUCTION & RADIATION TECHNOLOGY, NAPC) Making more, and cleaner water available to more people Understanding (WATER RESOURCES, NAPC) and protecting the environment (ENVIRONMENT LABORATORIES, NAEL) 4

5 Sustainable Development Goals 5

6 SDG #3: Good Health and Well-Being Building capacities in radiation sterilization of medical products (radiation technology) Ensuring the right dose is provided to the patients and products (radiation dosimetry) Improving diagnosis and treatment of cancer and chronic diseases; diabetes, CVDs (diagnostic imaging; radiotherapy; nuclear medicine; radiopharmaceuticals) Contributing to better nutrition (stable isotopes) Controlling vector of human diseases (human sleeping sickness, malaria, dengue, chikungunya and zika) (sterile insect technique) 6

7 SDG #9: Industry, Innovation and Infrastructure Enhancing capabilities in non-heu and accelerator based technologies for production of radioisotopes (accelerator; medical cyclotrons) Facilitating availability of radiopharmaceuticals for cancer/ncds patients (radioisotopes; radiopharmaceuticals) Supporting capacity to apply radiation technology for health care, food safety, cleaner industrial processes and better environment Enhancing capabilities in radiotracers and radiation based non-destructive testing for increased efficiency in industrial processes (radiotracers; NDT) 7

8 Serving Member States: How? Guidelines; curriculum E-learning >400 trainees per year (NA labs) Education and Training Provision of Services Dosimetry Plant varieties; insect strains Audit missions Reference materials Applied R&D Validation Technology Transfer 12 NA labs >20 Collaborating Centres >100 Coordinated Research Projects per year TECHNICAL COOPERATION PROGRAMME >130 LMI Member States million in 2015 (NA) 8

9 Programme description/objectives Programme 2.5 Radioisotope Production and Radiation Technology Programme 2.5 Radioisotope Production and Radiation Technology Sub-programme 2.5.1: Radioisotope Products for Cancer Management and non-communicable Diseases Sub-programme 2.5.2: Radiation Technology for Health Care and Industrial Applications Development and production of medical radioisotopes Development of diagnostic and therapeutic radiopharmaceuticals Industrial applications of radioisotopes and radiation techniques Radiation technologies for health care and environmental applications

10 IAEA Projects The IAEA can assist Member States in their work through various types of activities. These include: Coordinated Research Projects (R&D) 13 Technical Cooperation Projects (implementation) 150 Regular program activities Networks and coalitions Participation in complimentary, international activities Meetings / Conferences Missions Publications General Conference side-events and Scientific Forum Collaborating Centres 10

11 Radioisotope production Radiopharmaceutical production Diagnostic or therapeutic application

12 Cyclotrons Research reactor Radionuclide generator

13 Synthesis module Hot cell Layout

14 Projects Availing medical radioisotopes Therapeutic Radiopharmaceuticals Labelled with New Emerging Radionuclides ( 67 Cu, 186 Re, 47 Sc) New CRP Development of radiopharmaceuticals Development and preclinical evaluations of therapeutic radiopharmaceuticals based on Lu-177 and Y-90 labeled monoclonal antibodies and peptides Nanotheranostic: nanosized delivery systems for radiopharmaceuticals New CRP: Cu-64 Radiopharmaceuticals for Theranostic Applications November 2016 Education (e-learning, training modules, sylabus for Universities) Regulatory issues: Due to the increasing complexity of radiopharmaceutical preparations and the mandatory requirement of patient s safety, there exists a widespread demand to support regulators and preparation of guidelines of Good Manufacturing Practice (GMP) Updating radiopharmaceutical monographs for the International Pharmacopeia WHO Publications 14

15 Radioisotope production technologies The case of Mo-99 15

16 IAEA Organization for Mo-99 Activities Nuclear Energy Nuclear Fuel Cycle and Waste Technology Research Reactors Nuclear Applications Physical and Chemical Sciences Human Health Radioisotope products Physics- RR Applications Nuclear Medicine 16

17 IAEA s Mo-99/Tc-99m related activities Stability of supply of Mo-99 in Member States HEU minimization Indigenous production using non-heu targets Small-scale production of Mo-99 or Tc-99m for local use and associated regulatory aspects Coordination and participation in the OECD- NEA s HLG-MR New alternatives to Tc-99m 17

18 Reports OECD-NEA: Committee on State of Molybdenum-99 Production and Utilization and Progress Toward Eliminating Use of Highly Enriched Uranium; Nuclear and Radiation Studies Board; Division on Earth and Life Studies; National Academies of Sciences, Engineering, and Medicine: 18

19 Technical Cooperation Projects 19

20 Relevance to the TC Programme 54 Technical Cooperation projects in the field of radionuclide and radiopharmaceutical production for medicine are supported by Radioisotope Products and Radiation Technology Section. This number is expected to continue to increase according to trends observed in the last decade. Regional LA 2016: Peru, Chile, Mexico

21 Coordinated Research Projects 21

22 Developing Techniques for Small Scale Indigenous Molybdenum-99 Production Using LEU Fission or Neutron Activation (n, ) Member States IAEA 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 pdf 22

23 Accelerator-based Alternatives to Non- HEU production of Mo-99/Tc-99m participants from 16 Member States Production of Tc-99m in cyclotron - very successful: 6 hours irradiation time, 24 MeV, 450 A: 34 Ci of Tc-99m Clinical trials under way; regulatory approvals sought Self-sufficiency in hospitals/towns/country Good option for hospital or radiopharmacy; local productions Target specifications; reuse of targets etc. need consideration Comparison of cyclotron- and reactor-based Tc- 99m pertechnetate for the Univ. of Alberta Clinical Trial (cancer thyroid patients imaged postthyroidectomy) 23

24 Sharing and Developing Protocols to Further Minimize Radioactive Gaseous Releases to the Environment in the Manufacture of Medical Radioisotopes, as GMP ongoing Initiated as result of a request from a five Member States - May 2014 First Research & Coordination Meeting - August 2015 Second Research & Coordination Meeting planned 1Q 2017 Participants and observers from Australia, Belgium, Canada, France, Germany, Indonesia, The Netherlands, Pakistan, Poland, Rep. of Korea, USA. 24

25 New Ways of Producing Tc-99m and Tc-99m Generators Planned new CRP for 2017 Recommendation from Technical Meeting on same topic (March 2016) Aimed as use of low specific activity Mo-99 for generator preparation and accelerator production of Tc-99m 25

26 Training Events / Missions 26

27 Supporting the Global Deployment of Mo-99 Production Capacity for Nuclear Medicine Applications without the Use of HEU Started 2013 Aimed at assisting small-scale, national-level producers in setting up their production capability NOT aimed at creating commercial producers Supports LEU fission or n, -based production Expert missions to Mexico, Morocco, Peru, Poland and Romania (Egypt and Malaysia conducted earlier) 27

28 Interregional Training Courses & Workshops India (Board of Radiation and Isotope Technology) June participants from 12 MS Lectures, demonstrations and visits: o o o o o o Production and supply of Mo-99 Aspects related to (n,gamma) production Generators with low specific Mo-99 (gel generator) Solvent extraction of Tc-99m Hot cells Regulatory issues Kazakhstan (Institute of Nuclear Physics) Planned for 2017, in tandem with the closing of the round robin activity Round Robin Workshop To explore the use of Tc-99m radioactivity concentration units and high capacity absorbers for Mo Planned for

29 Mo-99 production by (n, ) Round Robin Objectives: Assist in organization of Round Robin for Mo-99 production by 0 n 1 capture Promote non-heu production pathways Facilitate estimates for local supply of Mo-99 Means: Provision of samples and procedures Advice and evaluation by international experts Irradiation results analysis, both individual & group Follow up workshops Expert missions to identified labs Results: 16 RR facilities Analysis - December 2015 workshop Demonstrated that ~1-3Ci/g specific saturation activities with flux of 1x10 14 cm -2 s -1 Summary paper accepted for publication in the Journal of Radioanalytical and Nuclear Chemistry 29

30 Thematic Technical Meetings 30

31 Global Capabilities for the Production and Manufacture of Molybdenum-99 Targets October participants from 15 Member States + EU Commission Objectives: Discuss current and upcoming techniques and capabilities for the manufacture of targets used in the production of Mo-99 LEU foil target (USA) Irradiation baskets (Belgium) Target holder and plates (Korea) 31

32 Regulatory Aspects of Radiopharmaceutical Production 7-11 December participants from 8 Member States Objectives and recommendations: To share experience of current radiopharmaceutical regulation status in participating MSs; To define a work plan for IAEA to support MSs that require assistance in this issue, in the form of education, training and harmonization tools; To evaluate the need for an IAEA publication with recommendations of how new facilities or those that need renovation can comply with national regulations. 32

33 New Ways of Producing Tc-99m and Tc-99m Generators March participants from 8 Member States Objectives: Evaluate alternative routes for the production of Tc-99m and Mo-99 Evaluate optimization of available generators Evaluate current status and potential development of Mo-99/Tc-99m generators using low specific activity Mo-99 Recommendations: Round-robin Training course New CRP Publication Concerns Supply of enriched Mo target materials Regulatory issues 33

34 IAEA Publications 34

35 Publications on Mo-99/Tc-99m Publication in progress Reference Plan for Self Sufficiency in the Supply of Selected Radioisotopes Produced in Research Reactors: Latin America Case Study CRP on the production of Tc 99m by cyclotron 35

36 Conferences & Upcoming Activities 36

37 Upcoming IAEA Conferences IMIC 2016 (Oct 10-14, 2016) Special Plenary Session on 12 Oct. Session VI : Radiopharmacy Kevin Charlton OECD role (HLG-MR) Sally Schwarz GMP in US (FDA; IND) Adriano Duatti Cardiac agents (Tc-99m, Tl-201 & PET) 2019 International Symposium on Trends in Radiopharmaceuticals (approved) proposed date May

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

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