NorthStar Medical Radioisotopes marked another milestone Wednesday as the company announced it had received a fifth federal approval for parts of its production process for substances used in medical testing.
The U.S. Food and Drug Administration approved NorthStar’s process for producing the medical radioisotope molybdenum-99, or Mo-99, from a concentrated isotope known as molybdenum-98.
The company uses its patented RadioGenix system to generate the isotope technetium-99m, or Tc-99m, that uses Mo-99 as its source material. Tc-99m is used in 40,000 patient imaging studies per day in the United States, helping doctors assess the extent of heart disease and cancer.
Wednesday’s approval marks the first and only commercial-scale application of Mo-98 technology and will increase domestic production and capacity of Mo-99 in the U.S.
NorthStar President and CEO Stephen Merrick said the recent FDA approval was a “transformational event” for the company. He called it a “key milestone in significantly increasing domestic production and capacity of non-uranium-based Mo-99 for the United States.”
In February 2018, NorthStar received its first FDA approval for aspects of its production process, paving the way for isotope production in partnership with the Missouri Research Reactor in Columbia, Missouri.
Since then, the company has grown rapidly in Beloit.
It ended 2020 at its 1800 Gateway Blvd. campus with the construction of a 34,700-square-foot expansion, part of an overall $40 million investment in the area. The project will accommodate two particle accelerators that will help produce radioisotopes, along with an accompanying processing facility.
Work on NorthStar’s isotope processing facility is complete, and equipment installation, testing and qualification remain on track, Merrick said.
After FDA approval, the isotope processing facility will augment processing at the Columbia-based reactor with an estimated completion by mid-2022.
Construction at the accelerator production facility remains on schedule, and the two particle accelerators are undergoing final testing in Belgium before being shipped to NorthStar.
“We expect the first pair of accelerators to be installed in early 2021 with FDA approval planned for late 2022, early 2023,” Merrick said.
He said the company expects to expand its full-time workforce of around 230 workers this year.