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More than 40,000 medical procedures conducted in the U.S. each day rely on a medical isotope called Molybdenum-99, yet this isotope is largely manufactured outside of the country.
And despite producing almost none, the U.S. uses nearly half of the world’s supply of Molybdeum-99 (Mo-99), which decays into an imaging agent used in medical diagnostic procedures for heart disease and cancer.
Two Wisconsin biotech companies are now on pace to become a critical part of the country’s Mo-99 supply network. Prior to 2018, the U.S. hadn’t produced this isotope domestically for 30 years.
Janesville-based SHINE Medical Technologies and Beloit-based NorthStar Medical Radioisotopes have each established unique methods to produce Mo-99 that they say are safer, cleaner and more reliable. In fact, neither method relies on a nuclear reactor nor highly enriched uranium (HEU), a factor that garnered each company millions in federal funding.
Since 2009, the Department of Energy’s National Nuclear Security Administration has been working with commercial partners to establish a domestic Mo-99 supply network. Part of the NNSA’s mission is to minimize the use of HEU in civilian applications.
Currently, the U.S. ships uranium to its suppliers outside the country. These nuclear reactor plants extract Mo-99 and then ship it back to the United States where pharmacies process Mo-99 into the imaging agent. From there, the isotope is delivered to hospitals around the country.
HEU is considered to be a proliferation-sensitive material that if diverted or stolen could be used as a component in nuclear weapons, according to the NNSA. Furthermore, Mo-99 decays at a rate of approximately 1% per hour, which means it can’t be stockpiled.
The proliferation risk is driving the NNSA to establish a domestic Mo-99 supply chain. However, the U.S. medical community’s reliance on foreign nuclear reactors for Mo-99 is another major factor, said Todd Senglaub, radiation safety officer at the Medical College of Wisconsin. He says these reactors are aging and will go offline on occasion, which can lead to Mo-99 shortages.
“This shortage issue and the reliance, it’s not just a Wisconsin problem or even a United States problem; it’s an international problem,” Senglaub said. “It just gets amplified here because we do so many more procedures.”
A Mo-99 production facility in the country could also curb any disruption in transportation, which Senglaub says U.S. isotope distributors likely experienced during the COVID-19 pandemic.
“This is going to dramatically help the molybdenum supply chain within the United States,” Senglaub said. “We could turn into a distributor for other places in the world then.”
In addition to SHINE and NorthStar, the NNSA has one other cooperative agreement with a Michigan-based company to produce Mo-99 using low-enriched uranium (LEU). However, NorthStar became the first domestic producer of non-uranium-based Mo-99 and has already begun supplying customers.
NorthStar’s technology uses a chemical processing technique to create a radioactive solution containing Mo-99. That solution is then shipped to radiopharmacies across the U.S., which use NorthStar’s onsite equipment to extract the imaging agent used in medical diagnostic procedures.
Meanwhile, SHINE finished exterior construction of its 46,000-square-foot medical isotope production facility in Janesville earlier this year and will start producing Mo-99 using LEU in late 2022.
SHINE currently has 329 employees and is looking to hire 36 more. The company expects to have 150 employees working at its new Mo-99 production facility in Janesville.
SHINE also plans to construct a second facility in Veendam, a municipality within the Netherlands’ Groningen province. Between both facilities, SHINE says it will have the capacity to produce double the European patient need for Mo-99, and 70% of the global patient need for this particular medical isotope by 2025.
Using steady-state neutron generators, SHINE smashes hydrogen isotopes together to create neutrons that split uranium atoms apart, which creates Mo-99. SHINE’s fusion technology can also be used to produce a myriad of isotopes used in nuclear medicine.
One of its Janesville facilities already produces Lutetium-177 or Lu-177, a medical isotope used in cancer treatment. Its Netherlands facility will eventually produce a broad range of medical isotopes.
While the technology these companies are producing have much broader implications for the world, their presence in Wisconsin has and will continue to have a local impact, said Lisa Johnson, chief executive officer of BioForward, an advocacy group and resource network for Wisconsin’s biohealth companies.
It’s estimated that Wisconsin’s biohealth industry generates $17.6 billion in direct annual economic output and more than $28.8 billion in overall economic impact (output) from direct, indirect and induced sources, according to BioForward’s 2020 report.
Employment in the industry has grown by 8%, outpacing overall job growth in Wisconsin (3%) since 2015. The industry contributes to 118,605 jobs in the state with an annual wage of about $87,000, according to the report.
“You have these very strong technology-oriented companies with high wages attracting more high wages into the state as these companies grow,” Johnson said.
SHINE, for example, relies on Wisconsin’s supply chain, and advanced manufacturing companies to build its technologies, said Greg Piefer, SHINE founder and CEO. In fact, Piefer thinks SHINE’s work could attract additional companies to Janesville in particular and Wisconsin in general.
“We’re going to be a highly technical company, so as we look towards building more complex and better technologies, anything that’s hard tech is going to like the skillset and ecosystem we’re building up here,” Piefer said.
It’s also possible that SHINE could attract companies to the state in the R&D pharmaceutical space, Senglaub said, adding that he expects SHINE will produce a variety of isotopes in the future.
“Maybe an R&D company wants to think outside of the box and use (a different isotope) as part of their research and development,” Senglaub said. “SHINE might be able to manufacture that for them, and they might be able to make it in small batches.”
But with a company like SHINE, it’s not just technology or high wages that will pull employees to Wisconsin; it’s the company’s long-term vision to use nuclear fusion to produce clean energy that will attract young talent, Johnson said.
The company is now on the second step of a four-phase plan to build additional capacity, capability and deepen its scientific understanding of fusion technology. However, it’s third phase, if achieved, will allow SHINE to recycle nuclear waste while its fourth phase would bring SHINE the capability to produce energy through fusion (the same process that powers the sun), which is cleaner and produces significantly more energy than coal, oil or gas.
“I consider that phase, if we achieve it, a level up moment for humanity,” Piefer said. “One of those key pivotal technologies that will drive human evolution for thousands of years going forward, if not longer.”