A new facility in Beloit will help Wisconsin increase domestic supplies of a critical isotope for the healthcare industry.
NorthStar Medical Radioisotopes recently completed the construction and installation of equipment at a new facility in Beloit to produce molybdenum-99 medical radioisotope. NorthStar will produce the isotope without using highly enriched uranium, reducing global risks of nuclear proliferation.
Max Postman, program manager for the domestic molybdenum-99 program at the US Department of Energy’s National Nuclear Security Administration, said the isotope is used in 40,000 diagnostic medical procedures every day.
“That’s a huge number of people benefiting from this isotope every day,” he said. “It’s often used in heart scans.”
According to Jim Harvey, NorthStar senior vice president and chief science officer, molybdenum-99 decays to technetium-99m, the radioisotope used in healthcare.
“The half-lives of these two isotopes are so long that you can’t mass-produce them and put them on a shelf,” he said. “They’re both ephemeral, so production has to be continuous.”
Harvey said the new facility will roughly double the company’s production capacity.
According to the National Nuclear Security Administration, NorthStar is currently able to meet approximately 20 percent of domestic demand for molybdenum-99. When the new plant is up and running, it will be able to meet almost 40 percent of US demand.
“We will significantly increase our ability to produce molybdenum-99, which will allow us to potentially serve a much larger portion of the overall market,” said Harvey.
The increased capacity will help ease supply shortages that hit the healthcare industry in November, according to Harvey.
Though NorthStar has been able to ramp up production to serve its customers during the shortage, the rest of the market hasn’t been so lucky, he said.
“The market suffered from major shortages from the current suppliers,” he said. “Unfortunately, there were patients who might have forgone their diagnostic scans, meaning they had to be postponed to a later date.”
At the facility, NorthStar will use a new process to produce the isotope that uses an electron accelerator.
Officials say the Beloit manufacturing site will be the first in the world to use this technology for molybdenum-99, and it also includes new equipment for packaging and distribution of the isotope.
“We are in the process of setting up a second production route that uses electron accelerators,” Harvey said. “At the same site we will also produce the therapeutic isotopes copper-67 and actinium-225, also using electron accelerators.”
While NorthStar has been producing molybdenum-99 since 2018, the United States has not been able to produce the isotope domestically for many decades, Postman said.
“The United States consumes about half of the world’s supply of molybdenum-99,” he said. “But for the most part over the past 30 years, we haven’t been able to produce this material domestically.”
He described highly enriched uranium as “weapons-grade nuclear material”. Postman said Congress passed legislation that would allow the National Nuclear Security Administration to work with the private sector to bring production back to the US — without using highly enriched uranium.
In fact, in 2018, NorthStar became the first American company in almost 30 years to produce molybdenum-99 domestically without using highly enriched uranium.
“We have recently not only completed our four-year history of reliably supplying the market, but also achieved another milestone of more than 200 production runs in the last four years,” said Harvey. “We are very proud of what we do.”
According to Postman, increasing domestic production of molybdenum-99 is critical as it will help shore up supply and make the US a global leader.
“You might think of molybdenum-99 as the ultimate perishable,” he said. “If you make a batch of molybdenum-99 and wait a little less than three days, about half of that material will have been lost to radioactive decay.”
Federal authorities have yet to approve the new method the facility will use to produce the isotope.
“The task now is to go through and generate the data that we need to submit to the FDA (US Food and Drug Administration) for approval in order to start using the equipment to sell material to our customers,” said Harvey . “Because these are human patients, FDA approval is required.”