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.

The Nuclear Regulatory Commission is holding a virtual event and teleconference on SHINE Medical Technologies’ plans to license and operate a medical isotope production facility in Janesville, Wis. The online public meeting will be held on July 27 from 7:00 p.m. to 9 p.m. (EDT).

The NRC is also seeking the public’s views regarding the agency’s draft supplemental environmental impact statement for SHINE’s application for a license to operate the facility, particularly regarding the conclusion that the environmental impacts are not great enough to prevent the NRC from considering issuance of the license.

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.

SHINE Europe, a nascent subsidiary of Wisconsin-based SHINE Technologies, announced Wednesday that it has secured funding to begin designing an advanced medical isotopes facility in Veendam, the Netherlands. The new facility will use the same fusion-based neutron generator system SHINE is employing at its Janesville, Wis., facility to produce medical isotopes, including molybdenum-99, which is used in diagnostic imaging.

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).

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.

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.

Bruce Power has harvested a second batch of Co-60 this year. Image: Bruce Power

Bruce Power announced on October 22 that it has completed its second harvest of cobalt-60 this year during an outage of Unit 8 of the Bruce nuclear power plant in Kincardine, Ontario, Canada. The company said that with this latest harvest, it will have provided the world enough of the medical isotope to sterilize 20 billion–25 billion pairs of gloves or COVID-19 swabs.

The Co-60 will be sent to Ottawa-based Nordion for processing and distribution over the next several weeks, according to Bruce Power. From there, the isotope will be shipped around the world for use in gamma irradiation to sterilize medical devices such as single-use gowns, surgical gloves, scalpels, syringes, and other critical health care equipment.

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.

The latest season of Amazon’s detective series Bosch premiered recently on its streaming service, Prime. The season opens with the murder of a medical physicist and the theft of radioactive cesium, with plenty of drama following as the protagonist tries to solve the murder and end the “catastrophic threat to Los Angeles.” The show is a work of fiction, but let’s take a closer look at the depiction of radiation to sort out the scientific facts.

The setup: The series stars Titus Welliver as Los Angeles Police Department detective Harry Bosch and Jamie Hector as his partner, Jerry Edgar. The first episode of the sixth and latest season begins late in the evening at a Los Angeles hospital. We are shown a nervous-looking medical physicist as he walks into a laboratory, the camera dramatically focusing on the radiation sign on the door. No one else is around as the medical physicist clears out the lab’s inventory of what we find out later is cesium. The physicist then walks the material out of the hospital without anyone giving him a second look.