NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced that the U.S. Food and Drug Administration (FDA) has approved the addition of two molybdenum-99 (Mo-99) filling lines at its facility in Columbia, Mo. Addition of the filling lines is part of NorthStar’s ongoing expansion plans to increase production and capacity of domestic, non-uranium based Mo-99 for the U.S. healthcare system. Mo-99 is a medical radioisotope used to produce technetium-99m (Tc-99m), the most widely used diagnostic imaging radioisotope and of critical importance for patient healthcare. FDA approval of the filling lines was made through expedited review of a Prior Approval Supplement to the original RadioGenix® System (technetium Tc 99m generator) New Drug Application, which was approved in 2018. The RadioGenix System is an innovative, high tech radioisotope separation platform for use in producing Tc-99m from non-uranium based Mo-99. Since commercial availability nearly 16 months ago, RadioGenix® Systems have provided customers with reliable Tc-99m supply for tens of thousands of patients’ diagnostic imaging studies, despite ongoing shortages from suppliers using legacy, uranium-based production methods.
NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, the University of Missouri Research Reactor (MURR®), in Columbia, Mo., using neutron capture technology. Natural Mo-98 is converted to Mo-99 at the MURR reactor and then processed into a radioactive Mo-99 solution. Filling lines at NorthStar’s facility on the MURR campus transfer the Mo-99 solution into tungsten-shielded containers called source vessels which are then shipped to radiopharmacies that have a RadioGenix System for use in producing Tc-99m used in combination with radiopharmaceutical kits and then injected into patients for diagnostic imaging studies.
“FDA’s expedited review and approval of the additional filling lines in our Columbia, Mo. facility means an immediate increase in Mo-99 production efficiencies in Columbia,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “This is one component of our efforts to increase dependable, domestically produced radioisotope supply for the United States. We particularly wish to express appreciation to our manufacturing partner, MURR. We look forward to continuing to work with MURR in progressing production efforts for concentrated Mo-98 (cMo-98), which, pending licensures and approval, will dramatically increase Mo-99 production capacity and our ability to provide larger-sized source vessels for our customers. We also want to thank Von Gahlen, who designed, built and installed these state-of-the-art filling lines.”
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