August 31, 2015 — 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, Missouri. The company will now be able to 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 six-day curies per process; a curie (Ci) is a unit of radioactivity and six-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.
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, according to James Harvey, Ph.D., NorthStar senior vice president and chief science officer. The company anticipates ultimately producing up to 3,000 six-day Ci at MURR.
For more information: www.northstarnm.com