NorthStar Medical Radioisotopes announced yesterday that it's adding a new filling line at the University of Missouri Research Reactor (MURR) production operations that will quadruple the company's capacity to produce molybdenum-99 (Mo-99) — the parent isotope of technetium-99 (Tc-99m)

NorthStar and Von Gahlen International, a radiation shielding manufacturer, are working together to design and install the new system. When it's complete, it will include a high-capacity DPharm unit to fill source vessels quickly along with companion hot cells for radiation containment.

In addition to increasing the dispensing capacity at MURR, the new filling line will also be able to prepare source vessels with Mo-99 generated from natural or enriched Mo-98 targets. The enriched targets have higher concentrations of Mo-98 and produce about three times more Mo-99 than natural targets.
Tc-99m is derived from Mo-99 and is used in the majority of SPECT imaging exams. Currently, the parent isotope is only produced in aging reactors that use weapons-usable highly enriched uranium (HEU). HEU causes safety and national security concerns, so companies in the U.S. — which currently does not have a commercial supply of the nuclear imaging isotopes — are working on creating a sustainable, domestic supply of Mo-99 using low-enriched uranium (LEU).

“This increased capacity will enable us to meet the anticipated demand for our non-HEU Mo-99 and our RadioGenix isotope separation system,” said George Messina, NorthStar chairman, president and CEO, in a statement. “Our recent progress toward commercialization of our production processes, and the encouraging feedback we’ve received from the marketplace, justify this investment. We are confident it will pay dividends for years to come."

In August 2015, NorthStar received approval to start routinely producing Mo-99 at the MURR facility in Columbia, Missouri. The company operates its proprietary aliquoting system at the MURR site to fill source vessels with Mo-99.

The announcement comes about one week after news that Stephen Merrick was brought on board as chief operating officer, a new role within NorthStar. Merrick will oversee day-to-day operations including engineering, production, and customer service, as the company advances toward FDA approval of its RadioGenix intelligent isotope separation system and commercialization of the two processes it is developing to generate Mo-99.

As for partnering with Von Gahlen International, Messina described the company as having deep knowledge of and extensive experience in radioisotope production, and called it "The perfect partners to help us complete this project.”

Installation is scheduled to begin in November, with full operability targeted for the first half of 2017.

Molecular Imaging Homepage