Shine Medical Isotopes yesterday broke ground on its first medical isotope production facility in Janesville, Wisconsin. Commercial production of isotopes, including molybdenum-99 (Mo-99), is scheduled to begin in 2021.

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

The groundbreaking ceremony was attended by federal, state, and local officials, including US Department of Energy (DOE) Under Secretary for Nuclear Security and Administrator of the National Nuclear Security Administration (NNSA) Lisa Gordon-Hagerty; Lantheus Medical Imaging President and CEO Mary Heino; and Janesville City Manager Mark Freitag.

"Construction of the Janesville production facility is a critical step toward establishing a reliable global supply of life-saving diagnostic and therapeutic isotopes for patients around the world," said Shine founder and CEO Greg Piefer.

Once complete, the 43,000-square-foot (4000-square-metre) facility will house eight of Shine's accelerator-based medical isotope production systems, capable of producing over one-third of global demand for Mo-99.

Ground was broken for Building One at the Janesville site in August 2017. Shine announced in February 2018 that it had completed construction and taken occupancy of that building, which will initially be used to house the first fully-integrated, full-size Shine production system. During construction of Shine's main production facility, Building One will be used to train employees and develop operating experience with equipment.

Shine submitted its construction licence application to the US Nuclear Regulatory Commission (NRC) in 2013. In October 2015, following an independent review of Shine's preliminary safety analysis report, the NRC's advisory committee on reactor safeguards recommended that a construction permit should be issued. In February 2016, the NRC issued a construction permit for the facility, the first it had issued for a non-power utilisation or production facility since 1985.

The groundbreaking follows the transfer by the city of Janesville in early April of a 91-acre plot of land on the south side of Janesville to Shine. The transfer was part of a tax increment financing deal between the company and the city. The land transfer came after Shine met several conditions set by the City, including approval of the necessary construction permits from the city, state, and the NRC, as well a financial audit providing proof of financial viability through construction of the facility.

Mo-99 is used in hospitals to produce the technetium-99m employed in around 80% of nuclear imaging procedures. Produced in research reactors, Mo-99 has a half-life of only 66 hours and cannot be stockpiled, and security of supply is a key concern. Most of the world's supply currently comes from just four reactors in Belgium, the Netherlands, Russia and South Africa, and recent years have illustrated how unexpected shutdowns at any of those reactors can quickly lead to shortages. Furthermore, most Mo-99 is currently produced from highly-enriched uranium (HEU) targets, which are seen as a potential nuclear proliferation risk.

Technetium-99m is used in over 40,000 procedures in the USA per day. However, there has been no commercial production of the isotope in the USA since 1989. Since 2009 the NNSA has been working in partnership with US commercial entities to accelerate the development of technologies to produce the radioisotope domestically, without the HEU, which are themselves seen as a potential nuclear proliferation risk.

Shine's system uses low-energy, accelerator-based neutron source to fission a low-enriched uranium target dissolved in an aqueous solution.

NNSA has supported Shine with a USD25 million cooperative agreement. Industry partners must match any funding amount. Shine was also recently selected with three other US companies to begin negotiations for another award of up to USD15 million to continue efforts to accelerate the establishment of a domestic supply of Mo-99.

"Today's groundbreaking is a win-win for our national security and the healthcare industry," said Gordon-Hagerty. "Domestic production of 'Moly-99' without HEU reduces global proliferation threats and ensures a reliable supply to healthcare providers who need it every single day for diagnostic medical procedures."