The Nuclear Regulatory Commission has approved a request by SHINE Medical Technologies for an exemption from regulations on how commercial grade equipment is defined, allowing the company to more easily procure components for the medical isotope production facility it is building in Janesville, Wis.

Completing a 5,700-mile journey from Belgium, two 24-ton particle accelerators were delivered to NorthStar Medical Radioisotopes’ facility in Beloit, Wis., on April 22, the Wisconsin State Journal reported. Photos and a video of the accelerators being received at the facility are included in the report.

The Monday session “Advancement in Medical Isotopes Production and Applications” of the 2020 ANS Virtual Winter Meeting was sponsored by the Isotopes & Radiation Division and co-chaired by Lin-Wen Hu of Massachusetts Institute of Technology and James Bowen of Pacific Northwest National Laboratory.

Radioisotopes produced from nuclear reactors and accelerators are widely used for medical diagnostics and cancer therapy. Technetium-99m (decay product of molybdenum-99), for example, is used in more than 80 percent of nuclear medicine diagnostic procedures. The session featured speakers who discussed the advancement and status of domestic production and applications of medical isotopes.

Wisconsin-based SHINE Medical Technologies announced on November 4 that its Therapeutics division has made its first commercial sales of lutetium-177 to multiple customers. Lu-177 is a therapeutic isotope in demand by clinical trial sponsors because of its potential to treat a range of cancers.

SHINE said that its production process enables the company to produce the high specific activity, non-carrier-added Lu-177 that is required by today’s clinical trials. In the short term, SHINE will produce Lu-177 at Building One of the company’s Janesville campus while a larger facility is being constructed exclusively for the production of the radioisotope. Building One, which was completed in 2018, houses SHINE’s first integrated, full-size production system and is used to train staff and develop operating history with the equipment.

Groundbreaking for the larger facility is expected in November. According to SHINE, the new production facility will be able to scale to support the company’s anticipated Lu-177 demand for the next five years. It will be capable of producing more than 300,000 doses of Lu-177 per year, the company said.

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.