Wisconsin-based fusion technology company SHINE Technologies has signed a long-term supply agreement with Nucleus RadioPharma for the supply of lutetium-177, a radioisotope used in cancer treatment therapies, including those in development for the treatment of neuroendocrine tumors, prostate cancer, and other solid tumors.

Fusion tech company SHINE Technologies announced that it is opening the largest facility in North America dedicated to the production of non-carrier-added lutetium-177, a medical isotope used in targeted cancer therapies.

An international collaboration between Bruce Power, Isogen (a Kinectrics and Framatome company), and ITM Isotope Technologies Munich SE (ITM) announced they have begun commercial production of lutetium-177 using Unit 7 of the Bruce nuclear power plant in Kincardine, Ontario. According to the companies, this marks the first time a commercial power reactor has been used to commercially produce short-lived medical radioisotopes.

SHINE Technologies, the Janesville, Wis.–based producer of medical radioisotopes, announced that it has submitted a drug master file (DMF) with the U.S. Food and Drug Administration for non-carrier-added (n.c.a.) lutetium-177 chloride, a radiopharmaceutical used for the treatment of cancer.

An international collaboration between Bruce Power, Isogen (a joint venture of Kinectrics and Framatome), and ITM Isotope Technologies Munich SE, announced a milestone marking the first time that lutetium-177, a short-lived medical radioisotope, has been produced in a commercial nuclear power reactor.

Bruce Power and Isogen, a partnership between Kinectrics and Framatome, have completed the installation of Isogen’s isotope production system (IPS) at Unit 7 of Bruce’s CANDU nuclear power plant in Ontario, Canada, making it the first power reactor in the world with installed capability to produce lutetium-177.

Bruce Power has received approval from the Canadian Nuclear Safety Commission (CNSC) to begin the production of lutetium-177, becoming the first power reactor globally to commercially produce the medical radioisotope. Isogen, a joint venture between Framatome and Kinectrics, will produce Lu-177 at Bruce’s eight-unit CANDU nuclear power plant in Ontario, Canada, using Isogen’s isotope production system (IPS).

SHINE Medical Technologies plans to locate its European medical isotope production facility in the Netherlands after a yearlong search and a review of more than 50 proposals from sites across Europe. The company announced on May 20 that construction at the site should begin in 2023 with commercial production starting in late 2025.

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.