NorthStar continues to invest heavily in non-uranium based processing and production capabilities for Mo-99 to ensure adequate capacity and appropriate supply redundancy. 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 eMo-98
Accelerator (Neutron Knock-Out) Production of Mo-99 using eMo-100
Regulatory approval of new Mo-99 manufacturing processes is simplified when compared to the initial New Drug Application (NDA). Supplements to the initial NDA can be used, and reviews are often completed in months or less.
Natural Molybdenum (nMo) Neutron Capture Production
nMo is NorthStar’s raw material for our current 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 an appropriate “neutron trap” in a reactor, the Mo-98 captures a “spare” neutron to become the medically useful Mo-99 isotope.
Enriched Molybdenum-98 (eMo-98) Neutron Capture Production
It is possible to extract the Mo-98 isotope from natural Molybdenum (nMo) and concentrate it to approximately 95% purity. Irradiation of the eMo-98 targets is therefore approximately four times more effective than the irradiation of nMo-98 targets, resulting in four times the amount of the medically useful Mo-99 isotope produced per gram of target material.
NorthStar is well advanced with its eMo program, and expects to submit for regulatory approval in the coming months.
Enriched Molybdenum-100 (eMo-100) Accelerator Production
NorthStar’s most efficient Mo-99 production process will involve accelerator production using enriched Mo-100. Naturally occurring molybdenum contains approximately 10% Mo-100 and can be processed to enrich Mo-100 to a concentration of approximately 95% purity. Electron accelerators can then be used to induce photo transmutation (neutron knock-out) to produce medically useful Mo-99. The accelerator process is more efficient at converting Mo-100 to Mo-99 than the neutron capture process of converting Mo-98 to Mo-99, so about 30% more Mo-99 is produced per gram of target material.
NorthStar has completed all proof of concept activities, and has initiated the Engineering work required to start construction of an accelerator facility at its Beloit facility.