US-based NorthStar Medical Radioisotopes has completed construction on its 20,000 square foot molybdenum-99 (Mo-99) processing facility in Beloit, Wisconsin, with equipment installation underway. 

The facility is part of NorthStar’s staged development and dual processing pathway approach to expanding current capacity and efficiencies in Mo-99 production. Domestically produced, non-uranium based Mo-99 is used in NorthStar’s RadioGenix System (technetium-99m generator). Northstar said the RadioGenix System, which is commercially available and approved by the Food and Drug Administration (FDA), is an innovative, high tech separation platform for processing non-uranium/non-highly enriched uranium based Mo-99 for production of Tc-99m.

Stephen Merrick, President and CEO of NorthStar said: “In conjunction with our partners at the University of Missouri Research Reactor (MURR), NorthStar is consistently providing domestic, non-uranium based Mo-99 now, and actively planning for the future. Upon appropriate licensure and FDA approval, this processing facility in Beloit will augment current processing at MURR, providing us with dual production hubs for Mo-99. The new facility will enable us to double production of RadioGenix System source vessels.”

He noted that, during the eight months since becoming commercially available, RadioGenix Systems have provided continuous, undisrupted domestic Mo-99 supply to meet customer and patient needs for Tc-99m. “In contrast, during the same time period, Mo-99 supply from the current supply chain, which is dependent on overseas nuclear reactors and processors, has been impacted by almost weekly disruptions, some being pronounced and lengthy,” he said.

In addition to the processing facility expansion, Northstar is working toward final validation of two state-of-the-art fill lines at our Columbia, Missouri facility that, pending expected FDA approval this year, will further substantially increase the number of Mo-99 source vessels. Activities for accelerator production of Mo-99 are also underway, with the initial accelerators ordered and ground-breaking for a 20,000 square foot accelerator facility in Beloit scheduled for later this year.