Current status and future perspective on Mo-99 / Tc-99m supply€¦ · IAEA: Production of Tc-99m...

IAEAInternational Atomic Energy Agency

Current status and future perspective on Mo-99 / Tc-99m supply

02 April 2015


Global perspective on Nuclear Reactors and Mo-99 / Tc-99m supply

Joao Alberto Osso JuniorHead, Radioisotope Products and Radiation Technology Section

IAEA

Contents

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

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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

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

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Fission Production flow of Mo-99/Tc-99m

Source: www.covidien.com6

http://www.covidien.com/

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Supply of Mo-99 crisis

• Supply problems since 2007• Main shortage in 2009• Ageing of Reactors• 2014: latest problem NTP• 2016: Nordion will cease

production: Extended to 2018

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Current irradiators of U targets

Source: http://www.oecd-nea.org/med-radio/reports/sen-hlgmr2014-2.pdf 8

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Current processors of irradiated U targets

Source: http://www.oecd-nea.org/med-radio/reports/sen-hlgmr2014-2.pdf

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Potental new irradiators


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Potential new processors


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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


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Current processing capacity and demand


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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

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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

IAEA

Role of the IAEA & Areas of involvement

• Promote beneficial uses of radioisotopes and radiation technologies and assist MSs in these areas

Mandate:

The Agency shall seek to accelerate and enlarge the contribution of atomic energy to peace, health and

prosperity throughout the world.

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IAEA

IAEA Organization for 99Mo Work

Office of the Director General

Department of Management

Department of Nuclear Science and Applications

Division of Physical and Chemical

Sciences

Radioisotope Products and

Radiation Technology Section

Department of Nuclear Energy

Division of Nuclear Fuel Cycle and

Waste Technology

Research Reactor Section

Department of Technical

Cooperation

Department of Nuclear Safety and

Security

Department of Safeguards

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SectionRadioisotope Production and Radiation Technology

Objectives

To contribute to improved healthcare and facilitatesafe and clean industrial development in MSthrough the use of radioisotopes and radiationtechnology and to strengthen national capabilitiesfor producing radioisotope products and utilizingradiation technology for socio-economicdevelopment

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IAEA

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

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IAEA Research Reactor Database

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99Mo IAEA Projects

The IAEA can assist Member States in their 99Mo work through various types of activities. These include: • Coordinated Research Projects• Technical Cooperation Projects• Regular program activities

• Networks and coalitions• Participation in complimentary, international activities• Meetings• Missions• Publications• General Conference side-events

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IAEA

IAEA Priorities for 99Mo

HEU Minimization

Transition of 99Mo 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

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HEU Minimization

Transition of 99Mo production away from

the use of highly enriched uranium (HEU)

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IAEA

IAEA Activities on 99Mo

• Collaboration with the OECD-NEA• IAEA 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

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Conversion of Major 99Mo Producers to LEU

• Supported by US DOE-NNSA and the Government of Norway

• Series of working group meetings for key stakeholders to review progress, exchange information and explore opportunities for mutually beneficial collaboration

• Receiving updates on LEU high-density targets, and accompanying chemical processes

• Last meeting: 6 February 2015

• New meetings: targetry

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Stability of Supply

Diversification of supply and movement to full

cost recovery to ensure the global demand is

met

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Role of RPRT with RR• Stability of supply of Mo-99 in MSs• Indigenous production using non-HEU targets: 235U(n,f)99Mo reaction98Mo(n,γ)99Mo reaction100Mo(p,2n)99mTc 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

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IAEA

IAEA Activities on 99Mo

• Small-scale, non-HEU production of 99Mo• A coordinated research project (CRP) on

“Developing Techniques for Small Scale Indigenous Molybdenum-99 Production Using LEU Fission or Neutron Activation.”

• CRP 2005-2011• 14 Member States• LEU fission or (n,γ) reacion• 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

http://www-pub.iaea.org/MTCD/Publications/PDF/trs478web-32777845.pdf

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Small-scale, non-HEU 99Mo production

• Technical Cooperation Project started in 2013 - PUI• “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 IAEA Member States wishing to receive advice

and assistance

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• Production infrastructure fact-finding missions were completed to Mexico, Morocco, Peru, Poland, and Romania. Similar missions were conducted in Egypt (2010) and Malaysia (2011)

• A training course on the practical aspects of the production of Mo-99 by the (n, γ) reaction. This training course will take place in Mumbai, India in June 2015.

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• 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)

• Publication: “Non-HEU Production Technologies for 99Mo and 99mTc”


http://www-pub.iaea.org/MTCD/Publications/PDF/Pub1589_web.pdf

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IAEA

Full Cost Recovery & Managing 99Mo Waste Streams

• Intended to study technical and economic aspects of 99Mo waste streams in cooperation with the OECD-NEA

• Work on this study was halted due to the low response rate (<50%)

• Without this information, the study would not have the necessary data to contribute any meaningful analysis

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Role of RPRT• CRP on the production of Tc-99m by cyclotron (3rd RCM

2015)• Support to TC projects

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IAEAA. Celler, X. Hou, F. Bénard, T. Ruth, Phys. Med. Biol. 2011, 56, 5469

IAEA CRP - Accelerator-based Alternatives to Non-HEU production of Mo-99/Tc-99m (2011-2015): 100Mo(p,x)

Production of 99mTc in Cyclotron

PETtrace TR19 CP42 34

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ARMENIA BRAZIL CANADA HUNGARY INDIA ITALY JAPAN KINGDOM OF SAUDI ARABIA POLAND SYRIA UNITED STATES

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(T1/2 = 6 h)

(T1/2 = 66 h)99Mo

100Mo(p,pn)99Mo

100Mo(γ,n)99Mo

98Mo(n,γ)99Mo

100Mo(n,2n)99Mo

100Mo(p,2n)99mTc

98Mo(d,n)99mTc

98Mo(p,γ)99mTc

99mTc

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100Mo(p,2n)99mTc

101Tcp n

n

100Mo

99mTc

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100Mo(p,2n)99mTc

Irradiation TargetProcessing Radionuclide

Separation

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Target preparation (withstand heat generated by the beam)

Radionuclidic separation Mo/99mTc: fast and high yield

Recovery of the target: enriched and high cost

Radionuclidic impurity: choose optimum beam energy, time of irradiation and decay time

Delivery of 99mTc

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99gTc97gTc

95gTc

94gTc

93gTc

100,9xMo(p,2n)9xTc series

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6 hours irradiation

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TRIUMF announcement on January 05th 2015 6 hours irradiation time, 24 MeV, 450 µA 34 Ci of Tc-99m Clinical trials in Canada early 2015 Last RCM: 22-26 June 2015 (Vienna)

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• 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-124

Role of RPRT

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IAEA

Upcoming 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 (August 2015)

• CRP on New Ways of Producing 99mTc and 99mTc Generators (TM 2Q 2015)

• TM on regulatory aspects of radiopharmaceutical production (3Q 2015)

• Support to TC projects

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Current status and future perspective on Mo-99 / Tc-99m supply€¦ · IAEA: Production of Tc-99m...

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