SHINE Medical Technologies expects in the next five years to site isotope production facilities in Europe and Asia, one staffer said Wednesday.
The company is currently more than a year from receiving anticipated federal regulatory approval to open its first production plant, in Janesville, Wis., for the medical isotope molybdenum-99 (Mo-99).
“At full capacity, SHINE intends to carry roughly two-thirds of international supply, although we potentially could grow,” Joseph Christensen, criticality safety engineering lead at SHINE, said during a session at the American Nuclear Society’s virtual 2020 annual meeting. “We have plans to site a European facility and eventually an Asian facility sometime in the next five years. We intend, as a company, to be able to handle the majority of the need for moly-99 worldwide.”
Christensen did not elaborate on the potential European and Asian operations. In a follow-up email Friday, SHINE declined to discuss factors it is considering in siting the facilities, nor the construction costs.
SHINE plans to use accelerator-based neutron source technology to produce Mo-99. Molybdenum-99 decays into technetium-99m, which the company says is used in 40 million medical procedures each year around the world, including diagnosing various cancers.
In July 2019, SHINE applied to the Nuclear Regulatory Commission for a 30-year operating license for its production facility. Last month, the company said it had been informed that the NRC expects to make a decision by October 2021.
The 43,000-square-foot plant, now under construction, is to have eight production units in which low-enriched uranium would be irradiated to produce Mo-99. Each unit will hold a neutron generator that SHINE has been co-developing with Phoenix LLC, a Monona, Wis., company that designs and builds neutron generators for various purposes. A neutron generator contains a particle accelerator that bombards a target with ions — a process starting to be used for production of Mo-99 without having to send highly enriched or low-enriched uranium to a reactor, which is the current standard approach for generating the isotope.
“The review schedule established by the NRC for our application reflects the quality of our submission, our effective engagement with NRC staff, and the diligence and hard work of the entire SHINE team,” SHINE CEO Greg Piefer said in the May 11 press release.
Construction of the Wisconsin facility has continued during the COVID-19 pandemic. SHINE expects to begin commercial output by 2022.
“We expect to begin construction of the European plant once the U.S. plant is up and running,” spokesman Rod Hise said by email Friday. When it is running at commercial scale, we expect the European plant to be capable of producing another one-third of the global patient need.”
SHINE is among several U.S. companies striving to re-establish domestic production capacity for molybdenum-99 that does not use weapon-grade uranium. For decades after 1989, the nation relied on foreign sources. One company, NorthStar Medical Radioisotopes, of Beloit, Wis., is already producing the isotope.
