NorthStar Medical Radioisotopes Receives Approval to Begin Routine Production of Molybdenum-99 at University of Missouri Research Reactor
Company can now regularly operate aliquoting line to fill source vessels with vital medical radioisotope
MADISON, Wis. – NorthStar Medical Radioisotopes LLC has received approval to begin routine production of molybdenum-99 (Mo-99) at the University of Missouri Research Reactor (MURR) facility in Columbia, Mo. The company will now be able regularly operate its proprietary aliquoting system at the MURR site to fill source vessels with Mo-99, enabling the company to establish a weekly production schedule and increase its output of the vital medical radioisotope.
This transitioning of NorthStar’s Mo-99 line at MURR from a development process to a routine production process is another significant step toward establishment of a domestic source of Mo-99. The company can immediately boost its output at MURR to as much as 200 6-day curies per process; a curie (Ci) is a unit of radioactivity and 6-day Ci is the number of curies present in a shipment of Mo-99 six days after it leaves the producer’s facility. NorthStar also will be able to further increase its Mo-99 output at MURR after the production process receives final approval from the U.S. Food and Drug Administration (FDA).
Mo-99 is the parent isotope of technetium-99m (Tc-99m), the most widely used radioisotope in medical diagnostic imaging. Currently, nearly all Mo-99 is generated using weapons-useable highly enriched uranium (HEU) at aging facilities located outside of the United States, leading to chronic product shortages and creating safety and national security concerns. NorthStar utilizes two technologies for producing Mo-99 from stable isotopes of molybdenum without the use of HEU – a neutron capture process wherein MURR supplies Mo-99 under its Drug Master File, and an accelerator process using Mo-100.
“Approval to routinely operate our aliquoting line is a major milestone toward becoming the first commercial producer of Mo-99 in the United States in more than 25 years and giving health care professionals nationwide reliable access to the Tc-99m they need to provide patients accurate diagnoses and conduct important research,” said James Harvey, Ph.D., NorthStar senior vice president and chief science officer.
“MURR is pleased to continue supporting NorthStar’s efforts to launch a domestic supply of Mo-99,” said Ralph Butler, MURR executive director.
The next significant step in the regulatory approval process will be submission of a final amendment to NorthStar’s New Drug Application (NDA) with the FDA. This is expected to occur late this year, Harvey said.
“NorthStar also will soon make a substantial investment in its operations at MURR to enable future production increases,” Harvey said. The company anticipates ultimately producing up to 3,000 6-day Ci at MURR.
NorthStar Medical Radioisotopes LLC
Based in Madison, NorthStar Medical Radioisotopes LLC (northstarnm.com) was founded in 2006 to address the needs of the nuclear medicine market in the United States. A wholly owned subsidiary of NorthStar Medical Technologies LLC, the company is committed to resolving industry-wide supply challenges that have caused shortages of vital medical isotopes, negatively impacting patient care and stalling clinical research. Its patented technologies include innovative non-uranium based molybdenum-99 production methods, a novel separation chemistry system and tools for the nuclear medicine market.