NorthStar Medical Radioisotopes has begun routine production of molybdenum-99 (Mo-99) at the University of Missouri Research Reactor facility in Columbia, MO.
The company will now be able to operate its proprietary aliquoting system at the site to fill source vessels with Mo-99, allowing NorthStar to establish a weekly production schedule and increase its output of the radioisotope.
Production at the Missouri site is a significant step toward establishing a U.S. source of Mo-99, according to NorthStar. This also means NorthStar can immediately boost its output at the facility to as much as 200 6-day curies (Ci) per process; 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 anticipates ultimately producing up to 3,000 6-day Ci. The firm also will be able to increase its Mo-99 output at the Missouri site 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). Currently, nearly all Mo-99 is generated using highly enriched uranium (HEU) at aging facilities located outside of the U.S. with chronic product shortages and safety and national security concerns. NorthStar uses two technologies for producing Mo-99 from stable isotopes of molybdenum without the use of HEU -- a neutron-capture process where the Missouri site supplies Mo-99 under its drug master file, and an accelerator process using Mo-100.
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, which is expected to occur late this year.
