NorthStar continues to invest heavily in non-uranium based processing and production capabilities for Mo-99 to ensure adequate capacity. Ongoing research is underway to explore alternative approaches to irradiation and include our accelerator program which uses electron accelerator technology rather than a reactor. Our accelerator manufacturing facility will be built in Beloit, Wisconsin.
Non-uranium based processes are proven and well established, yet mark a significant advancement to current technology. By utilizing state-of-the-art chemical processing to achieve domestic Mo-99 production without the use of any uranium target material, NorthStar’s product meets all appropriate Pharmacopeia standards for Mo-99.
Importantly, this process provides an environmentally friendly solution for Mo-99 supply, because it produces benign and recyclable waste streams that are free of the toxic and radioactive waste associated with uranium-based production.
NorthStar’s Non-uranium Based Manufacturing Process
Our non-uranium Mo-99 processing involves three distinct development phases
Neutron Capture Production of Mo-99 using nMo
Neutron Capture* Production of Mo-99 using cMo-98
Accelerator* (Neutron Knock-Out) Production of Mo-99 using aMo-100
*Not Approved by the FDA. Regulatory approval of changes to the RadioGenix System, Potassium Molybdate Mo 99 Source Vessels and their components may require submission of supplements to NorthStar’s New Drug Application. FDA typically reviews and approves these supplements in several months or less.
Natural Molybdenum (nMo-98) Neutron Capture Production
nMo is NorthStar’s raw material for our current FDA approved Mo-99 production process. It is found in the earth’s crust as molybdenite and is most commonly used for manufacturing high strength alloy steels. About 24% of naturally occurring Molybdenum (nMo) is the useful (and stable) Mo-98 isotope. When small discs (called “Targets”) are placed in the “neutron flux trap” in a reactor, the Mo-98 captures a “spare” neutron to become the medically useful Mo-99 isotope.
Concentrated Molybdenum-98 (cMo-98) Neutron Capture Production
It is possible to extract the Mo-98 isotope from natural Molybdenum (nMo) and concentrate it to approximately 95% weight percent. Irradiation of these cMo-98 targets is therefore approximately four times more effective than the irradiation of nMo-98 targets, thus resulting in four times the amount of the medically useful Mo-99 isotope produced per gram of target material.
NorthStar is in the advanced stages of developing its cMo program and plans to submit for regulatory review in the coming months.
Accelerator Molybdenum-100 (aMo-100) Accelerator Production
NorthStar’s most efficient Mo-99 production process will involve accelerator production using aMo-100. Naturally occurring molybdenum contains approximately 10% Mo-100 and can be processed to concentrate Mo-100 to approximately 95% weight percent. Electron accelerators then can be used to induce photo transmutation (i.e., neutron knock-out) to produce medically useful Mo-99. The accelerator process is more efficient at converting Mo-100 to Mo-99 than the current neutron capture process of converting Mo-98 to Mo-99, so about 30% more Mo-99 is produced per gram of target material when compared to the neutron capture production route.
Early in 2019, NorthStar announced signing a contract for the purchase of as many as eight Rhodotron® TT300 HE electron beam accelerators from IBA (Ion Beam Applications, a leading global supplier of accelerators, focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer). NorthStar issued purchase orders for the first pair of accelerators and completed a groundbreaking for its 30,000 sq. ft. Accelerator Production Facility in September, 2019. The first pair of accelerators are expected to arrive in Beloit during Q4 of 2020.