Ongoing product development programs such as the FDA-approved RadioGenix System version 1.2 continue to help maximize operational utility and efficiency for customers in the production of Tc-99m.
Progress on initiatives to increase U.S. Mo-99 manufacturing and production

In its efforts to support increased Mo-99 production efficiencies and capacity, NorthStar is aggressively expanding for the future to ensure continued reliable domestic Mo-99 supply for the U.S. healthcare system. The company is executing on its multi-pronged expansion strategy for dual production hubs in Beloit, Wis., and Columbia, Mo.


In February, 2020, the FDA approved the addition of two Mo-99 filling lines at NorthStar’s facility in Columbia, Mo., enabling an immediate and significant increase in the speed in which RadioGenix System source vessels are filled, and thus increasing production efficiency and output. NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, MURR®.
NorthStar has two ongoing expansion projects underway in Beloit. The company’s isotope processing facility is nearing completion, and will augment processing at MURR® once approved. Upon appropriate licensure by Wisconsin DHS and FDA approval, the facility will enable NorthStar to more than double its production of source vessels, which are used by radiopharmacies with RadioGenix Systems to produce Tc-99m for physicians and their patients.
In March 2019, NorthStar signed a contract with IBA for eight electron beam accelerators. Groundbreaking on its accelerator production facility took place in September 2019, and construction in Beloit is well underway. The initial pair of accelerators is being assembled in Belgium, with installation planned for Q4 2020. Like other NorthStar processes, accelerator production of Mo-99 using the “neutron knock-out” method is non-uranium based, highly efficient and, pending FDA approval, can provide customized scheduling flexibility and minimize supply risks for customers.
In mid-2020, NorthStar anticipates submitting a Prior Approval Supplement (PAS) to the FDA for concentrated Mo-98 (cMo-98). Pending FDA approval, the cMo-98 production process will improve Mo-99 specific activity concentration up to four-fold, and immediately enable larger capacity and multiple sizing options for Mo-99 source vessels for RadioGenix System customers.
NorthStar currently has the capability to meet up to approximately 10% of the U.S. demand for Mo-99. The company’s production capacity is expanding approximately every six months, with the expectation that within three to five years, it will have the capability to regularly supply an estimated 65% of U.S. Mo-99 demand, and up to 100% of U.S. demand in an emergency.

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