NorthStar Progress Towards Domestic Mo99 Production
Transcript of NorthStar Progress Towards Domestic Mo99 Production
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NorthStar Progress Towards Domestic Mo99 Production
J.T. Harvey, G.H. Isensee, S.D. Moffatt, G.P. Messina
NorthStar Medical Technologies, LLC
5249 Femrite Drive, Madison, WI 53718 – USA
Mo-99 2014 TOPICAL MEETING ON
MOLYBDENUM-99 TECHNOLOGICAL DEVELOPMENT
June 24-27, 2014
Washington D. C.
7/8/2014 Copyright © 2013-2014 NorthStar Medical Radioisotopes, LLC 1
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Topics
• Background on Mo99 Production at NorthStar
o Neutron Capture Effort (neutron capture technology track)
o Photon Capture (LINAC) Effort (accelerator technology track)
• Status Update
• Summary & Discussion
7/8/2014 Copyright © 2013-2014 NorthStar Medical Radioisotopes, LLC 2
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Background on Mo99 Production at NorthStar
• Near Term Solution – Neutron Capture
• Missouri University Research Reactor
• Contract in place effective March 2011
• Long Term Solution – Photon Capture
• NorthStar’s LINAC methodology for the production of Molybdenum-99
• It is expected that this solution will eventually be able to produce 50+% of the US requirement
• Once up and running both solutions will be used to supply not only the US market but also ROW.
These two approaches require NorthStar’s RadioGenix™ technology in order to guarantee success
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Background on Mo99 Production at NorthStar Neutron Capture
• NorthStar has been active in this option since 2009
o MURR originally produced Mo99 with nat-Mo
• NorthStar/MURR capable of producing up to 3,000+ 6D Ci per week
o SA of Mo99 1Ci/g – 6Ci/g potentially,
o one target set per week (100 6D Ci – 3,000+ 6D Ci Mo99; nat or enriched Mo dependent) processed,
o steady weekly production, and
o Dedicated shipping to client pharmacies; UPS/FedEx Ground can handle return of spent Mo99 solutions for recovery & recycle (if enriched Mo98 used); otherwise dispose of after DNS by NorthStar
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Background on Mo99 Production at NorthStar Neutron Capture
• MURR has outstanding operational record,
• MURR/NorthStar production agreement announced March 1st, 2011
o Extension to 2019 being finalized
o Batch size scale-up under review
• Production upon FDA approval,
• Supported by NNSA Cooperative Agreement, and
• No licensing issues.
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Background on Mo99 Production at NorthStar Neutron Capture
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Background on Mo99 Production at NorthStar Photon Capture (LINAC)
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• NorthStar has been active in this field since Nov 2007 o NorthStar funded effort at RPI in early 2008 to validate the 1999 INL
publication o Produced small quantities of Mo99 in that study and validated calculated
estimates and experimental results were comparable
• NorthStar facility will house up to 16 LINAC machines initially capable of producing >3,000+ 6D Ci per week o SA of Mo99 ~10Ci/g potentially o one target set per day (~2,500Ci Mo99) processed o steady, redundant production on a daily basis o Site expansion space set aside for additional 16 LINAC machines as needed o NNSA supported via Cooperative Agreement
• Facility location - Beloit, WI o Located immediately adjacent to a new power substation being built with
NorthStar requirements incorporated in the design
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Status Update Neutron Capture
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• MURR has filed the scale-up DMF with the FDA on July 2, 2013 o Original DMF filed in September 2012
• NorthStar in process of completing setup of the Mo99 dispensing line at MURR o Physical install complete
o Validation hot runs scheduled for completion 3QTR14
o Dispensing Line Amendment ready 1QTR15; submitted as part of Final Amendment to NDA 2QTR15
o Inspection ready 1QTR15
• Certification of NorthStar’s Type A shipping system completed in 4QTR13
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Status Update Neutron Capture
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Status Update Neutron Capture
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Status Update Neutron Capture
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Status Update Neutron Capture
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Status Update Neutron Capture
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Status Update Beloit Facility
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Status Update Beloit Facility
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Status Update Beloit Facility
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Status Update Photon Transmutation
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• Production relevant thermal tests at both 35MeV and 42MeV performed at ANL LINAC facility 2QTR14
o Production testing scheduled to start next month
5 – 24 hour irradiations
1 – 6.5 day irradiation
Load processed Mo99 on generating system and run for 14 period
Product testing per USP
• Beloit Gateway facility design continues
o Currently in permitting process to begin construction of first building on the site
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Status Update Beloit LINAC Facility
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Status Update Beloit LINAC Facility
7/8/2014 Copyright © 2013-2014 NorthStar Medical Radioisotopes, LLC 19
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Summary
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• All MURR operations supporting NorthStar to be inspection ready by 2QTR15
• Neutron capture production upon FDA approval of NorthStar’s NDA for the generating system
o 100 6D Ci/wk at introduction w/ high purity nat-Mo targets
o Ramp to 750 6D Ci/wk within 6 months of start
o Transition to eMo98 targets in 2016
Additional DMF and Supplement to NDA required
o Production capability goal of up to 3,000 6D Ci by 4QTR16
• NorthStar announced on June 7th at SNMMI execution of an LOI with Triad Isotopes to supply domestic non-HEU Mo99 to Triad nuclear pharmacies once FDA approval is achieved
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Summary
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• Photon transmutation efforts continue with optimization of production parameters including curie level production and generator system runs 3QTR14
• Facility construction starting as soon as permits granted o Building to support initial ISO 8 manufacturing and administrative needs of
50,000 sqft
o First of planned site expansion that includes supports production growth needs and LINAC building
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NorthStar Progress Towards Domestic Mo99 Production
J.T. Harvey, G.H. Isensee, S.D. Moffatt, G.P. Messina
NorthStar Medical Technologies, LLC
5249 Femrite Drive, Madison, WI 53718 – USA
Mo-99 2014 TOPICAL MEETING ON
MOLYBDENUM-99 TECHNOLOGICAL DEVELOPMENT
June 24-27, 2014
Washington D. C.
7/8/2014 Copyright © 2013-2014 NorthStar Medical Radioisotopes, LLC 22