SHINE Medical Technologies has submitted an application to operate its future Janesville medical radioisotope production plant, the final major regulatory hurdle SHINE must clear, the company said.
As SHINE readies for the construction of its 43,000-square-foot medical molybdenum-99 production plant on Janesville’s south side, the company announced Monday it has handed a 3,700-page operating license application to the federal Nuclear Regulatory Commission.
The application took SHINE employees the equivalent of 150,000 man hours to complete, the company said in a release.
Within 60 days, SHINE’s application will go on the federal nuclear agency’s docket, and it could take 18 to 24 months for SHINE to gain approval.
The license would allow SHINE to create moly-99 and other medical isotopes using nuclear particle accelerators, SHINE spokesman Rod Hise said.
SHINE would ship the material to specialty pharmacies globally, the company has said.
Katrina Pitas, SHINE’s vice president of business development, said the time during which federal authorities will vet SHINE’s application would coincide with SHINE’s timeline to ramp up and begin commercial production in Janesville sometime in 2022.
Construction of the Janesville plant will roll out in tandem with the review process, she said.
“There’s no change to the timeline,” Pitas said. “Our timeline has always assumed that the NRC will take the full 24 months.”
Federal nuclear authorities took a full 24 months to review and ultimately approve a construction permit for SHINE’s facility. Pitas said SHINE is optimistic the operating permit review process could take as little as 18 months.
SHINE broke ground earlier this year on the Janesville plant, which the company believes could supply up to one-third of the global supply of moly-99.
Moly-99 is a radioactive material used to illuminate bone and body tissue in medical tests.
Pitas said contractors have nearly completed preparation for the Janesville plant. She declined to give a date when physical construction of the plant might start.
SHINE has been on pace to be the first private company in the U.S. to use its own accelerators to produce moly-99. The company is now testing its equipment at a demonstration facility it built last year in Janesville.
Earlier this year, SHINE’s tests showed its accelerator technology has more than ample power for full- scale radioisotope production, the company said.