News | Radiopharmaceuticals and Tracers | August 31, 2015

NorthStar Medical Radioisotopes Approved to Begin Routine Production of Molybdenum-99

Company will regularly operate aliquoting line at University of Missouri Research Reactor

NorthStar Medical Radioisotopes, approval, routine production, Molybdenum-99, Mo-99, University of Missouri Research Reactor, MURR

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

Related Content

Spectrum Dynamics Sues GE for Theft, Misappropriation of Trade Secrets and Unfair Competition
News | SPECT Imaging | December 06, 2018
Single-photon emission computed tomography (SPECT) cardiac imaging company Spectrum Dynamics filed a lawsuit Dec. 6,...
Subtle Medical Receives FDA Clearance, CE Mark for SubtlePET
Technology | PET Imaging | December 05, 2018
Subtle Medical announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtlePET. Subtle...
Mirada Medical Joins U.K. Consortium Exploring Healthcare AI
News | Artificial Intelligence | December 04, 2018
Mirada Medical, a leading global brand in medical imaging software, will form part of an artificial intelligence (AI)...
GE Healthcare Recalls Millennium Nuclear Medicine Systems
News | Nuclear Imaging | November 15, 2018
GE Healthcare announced it is recalling its Millennium Nuclear Medicine Systems due to an incident in which the the top...
Artificial Intelligence Predicts Alzheimer's Years Before Diagnosis
News | Neuro Imaging | November 14, 2018
Artificial intelligence (AI) technology improves the ability of brain imaging to predict Alzheimer’s disease, according...
Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
Subtle Medical Showcases Artificial Intelligence for PET, MRI Scans at RSNA 2018
News | Artificial Intelligence | November 13, 2018
At the 2018 Radiological Society of North America annual meeting (RSNA 2018), Nov. 25-30 in Chicago, Subtle Medical...
University of Missouri Research Reactor First U.S. I-131 Supplier in 30 Years

MURR is the only supplier of I 131 in the United States and the first U.S. supplier since the 1980s. Image courtesy of University of Missouri

News | Radiopharmaceuticals and Tracers | November 13, 2018
The University of Missouri Research Reactor (MURR) recently shipped its first batch of Iodine-131 (I-131), a...
MEDraysintell Projects Increasing Mergers and Acquisitions in Nuclear Medicine
News | Nuclear Imaging | November 07, 2018
With the recent announcement by Novartis to acquire Endocyte , interest from the conventional pharmaceutical industry...
A PET/CT head and neck cancer scan.

A PET/CT head and neck cancer scan.

Feature | Nuclear Imaging | November 05, 2018 | By Sabyasachi Ghosh
“Experimental validation implemented in real-life situations and not theoretical claims exaggerating small advantages