In 2009, the supply of molybdenum-99, a precursor to technetium-99m used in more than 30 medical imaging procedures, fell short of demand due to maintenance idling of a pair of research reactors, one located in the Netherlands, forcing doctors to use more dangerous isotopes. By 2016, the largest global supplier of the isotope, a Canadian research reactor, was scheduled to go idle. In 2010, the National Nuclear Security Administration, a part of the United States Department of Energy, began funding a number of method development ventures aimed at ensuring that shortages in the United States could be avoided as well as reducing the use of highly enriched uranium and with it lowering the risk of nuclear proliferation. SHINE was among a handful of early recipients of funds from the NNSA program and received through it as of 2014. SHINE has also relied on venture capital funding, having secured up to from Deerfield Management beginning in October 2014. The 2014 market for medical isotopes was estimated to be about per year. Several companies in addition to SHINE are vying for part of this market, and the need for redundancy in production will support a number suppliers beyond the minimum needed to meet current demand. The company plans to start production scale generation of isotope in 2018, having pushed the proposed start date back several times, it has secured a number of supply agreements predicated on this start date. In addition to supplying Mo-99, SHINE has secured a National Science Foundation grant to develop production methods for Iodine-131, used in the treatment of Graves' disease and certain cancers.
Facilities and technology
Original technology for production of Mo-99 was reactor-based and unavoidably produced significant nuclear waste. SHINE plans to use particle accelerator technology developed at the University of Wisconsin–Madison by company founder Gregory Piefer. The method, referred to as "neutron generator technology", uses helium and free neutrons, produced by colliding a beam of deuterium particles with tritium gas, to bombard low-level enriched uranium targets leading to the production of "useful isotopes with minimal waste." In addition to the diagnostically useful Mo-99, the process can also produce Iodine-131, used in medical treatments. In 2013, SHINE constructed a full-scale prototype particle accelerator at their Monona, Wisconsin facility to be used to demonstrate the technology. Eight accelerators would be used at the Janesville facility. On June 15, 2015, Argonne National Laboratory demonstrated that SHINE's production, separation and purification process could produce Mo-99 which meets purity specifications of the British Pharmacopoeia. The NRC approved SHINE's construction permit for a facility in Janesville, Wisconsin in late February 2016. If constructed, the facility would still require NRC licensing to operate. In 2014 the facility was originally slated for opening in 2016, was then delayed to 2017. As of February 2016, construction was planned for 2017 with production potentially beginning in 2019.
