US regulator accepts SHINE's radioisotope operating licence application

16 October 2019

The US Nuclear Regulatory Commission (NRC) has accepted SHINE Medical Technologies' operating licence application for its medical isotope production facility in Janesville, Wisconsin. SHINE said the NRC's acceptance confirms that its application was "complete and of sufficient quality" for the NRC to start its detailed technical review of the application.

An artistic impression of how SHINE's production facility could appear (Image: SHINE)

SHINE's application seeks regulatory approval to operate its transformational non-reactor technology that will produce medical isotopes, including molybdenum-99 (Mo-99), which the company says is used in more than 40 million medical procedures every year. The facility will be capable of supplying two-thirds of US patient demand for the isotope. SHINE expects to begin production of Mo-99 in 2021, with commercial production starting in 2022.

"The NRC's review of our operating license application is another step forward for SHINE’s effort to commercialize the Mo-99 isotope through our first-of-its-kind medical isotope production facility," said Greg Piefer, SHINE's founder and CEO.

Jim Costedio, SHINE's vice president of regulatory affairs and quality, added that development of the operating license application had logged more than 150,000 person-hours of work.

SHINE, which broke ground on construction in May, said ongoing excavation at the site of the facility began in September. The next step in the construction process, concrete work, is expected to start this month.

The next step involves the NRC conducting a regulatory audit to determine a detailed schedule for the remainder of the review.

Researched and written by World Nuclear News