NorthStar Medical Radioisotopes said this week it has finished building a facility for processing the medical isotope molybdenum-99 (Mo-99).
The 20,000-square-foot plant in the company’s home city of Beloit, Wis., will eventually be used to dissolve irradiated molybdenum-99 targets to fill NorthStar’s Mo-99 source vessels. It is expected to more than double NorthStar’s current output of the source vessels, which today are filled with Mo-99 processed through the University of Missouri Research Reactor Center in Columbia, Mo.
The vessels are ultimately shipped to radiopharmacy customers, which use NorthStar’s RadioGenix System to produce the diagnostic-imaging isotope technetium-99m.
NorthStar did not release the cost of the new facility.
Construction in Beloit wrapped up at the end of June, and is expected to be followed by 12 months of equipment installation, including multiple hot cells for dissolving the Mo-99 targets irradiated at the University of Missouri reactor and automated for filling the source vessels. The facility will then require state and federal regulatory approval to begin commercial production.
Approval from the U.S. Food and Drug Administration for operations like that planned for Beloit generally requires four months, a NorthStar spokesperson said by email. “However, these are entirely new processes and equipment, so it is difficult for us to provide specific timing guidelines. We anticipate that the entire process of approval, commissioning and licensing may take a couple of years. Site license amendments by the State of Wisconsin will also be required and will be managed in parallel with FDA submissions.”
Molybdenum-99 decays into technetium-99m, which NorthStar said is the No. 1 used isotope for diagnostic imaging. It is employed in roughly four-fifths of all nuclear medicine procedures around the world, according to the National Center for Biotechnology Information.
For decades starting in 1989 the United States did not have a domestic manufacturing source for molybdenum-99, leaving it at the mercy of sometimes erratic supplies from foreign manufacturers. NorthStar and a number of other U.S. companies have sought to address that situation.
NorthStar put its RadioGenix System on the market eight months ago. The Mo-99 source vessels to date are estimated to have provided technetium-99m for over 10,000 patients, the spokesperson said.
The company is also advancing development of a separate approach for molybdenum-99 production, which would use an accelerator rather than a nuclear reactor.
“NorthStar is further planning for expanded production capacity with the addition of electron beam accelerators to complement irradiation activities at Columbia,” the spokesperson wrote. “The initial pair of eight total accelerators have been ordered and should arrive next year. Groundbreaking for the accelerator facility in Beloit is slated for this autumn.”
NorthStar is one of four companies each set to receive up to $15 million from the U.S. National Nuclear Security Administration to further their molybdenum-99 production methods. The semiautonomous Department of Energy agency announced it would begin negotiations with the companies on cooperative agreements worth a total of $60 million. The other companies are SHINE Medical Technologies, of Janesville, Wis.; Northwest Medical Isotopes, of Corvallis, Ore.; and Niowave, of Lansing, Mich.
Each company is required to match the federal funding. Their production methods must not use nuclear weapon-usable highly enriched uranium and must show they can scale up to 3,000 6-day curies of mo-99 per week.
“NorthStar hopes to hear from DOE/NNSA soon about the Cooperative Agreement,” the spokesperson wrote. “In the interim, it is premature for the company to discuss potential use of funds.”
In 2010, the NNSA issued two cooperative agreements worth $50 million in matching funds to NorthStar. The company used that money to advance development and regulatory approval of its neutron capture and accelerator-based isotope production methods.
