Shine Medical Technologies, which is building a medical isotope production facility in Janesville, Wis., said on May 11 that it expects to have an operating license issued by the Nuclear Regulatory Commission by October 2021. Shine’s application seeking approval to operate the facility, which will produce isotopes including molybdenum-99, was accepted and docketed by the NRC last October. Mo-99, the precursor to technetium-99m, is used in more than 40 million medical patient procedures every year.
According to Shine, the facility’s construction has continued during Wisconsin’s stay-at-home order under applicable health guidelines and is moving forward according to plan. Shine expects the building to be weather-tight by the end of 2020 and hopes to be producing Mo-99 at commercial scale by 2022. Shine said that the facility, once completed, will be capable of supplying two-thirds of the U.S. patient demand for Mo-99.
What they’re saying: “The completion of Shine’s production facility is critical to patients in the United States,” said Greg Piefer, the company’s chief executive officer. “The supply chain that serves U.S. patients is almost entirely reliant on foreign suppliers. The restriction of isotope shipments from Europe during the current global health crisis reinforces the profound need for substantial, reliable domestic production of Mo-99.”
Piefer added that the NRC’s schedule for reviewing Shine’s license application “reflects the quality of our submission, our effective engagement with NRC staff, and the diligence and hard work of the entire Shine team.”