by John R. Fischer
, Senior Reporter | February 19, 2018
SHINE Medical Technologies Inc. (SHINE) has completed construction on and begun occupying the first building of its medical isotope production campus in Janesville, Wisconsin.
The completion of Building One moves the Wisconsin-based enterprise one step closer to being the first domestic source in the U.S. for the production of molybdenum-99 (Mo-99) which, along with other radioisotopes produced there, will go toward the detection and treatment of various diseases, such as heart disease and cancer.
"The fact that SHINE is building new moly-99 production and processing infrastructure means we will have the most reliable supply of moly-99 in the world," Katrina Pitas, vice president for business development at SHINE, told HCB News. "Because we don’t use a reactor, SHINE’s process creates dramatically less nuclear waste than any process that does, and creates moly-99 that is 10,000 times more concentrated than moly-99 produced by typical accelerator processes."
The completion of Building One follows the FDA’s clearance
of NorthStar’s RadioGenix System for the production of Mo-99, pushing the two enterprises further in their competition to bring a domestic, non-uranium-based source of Mo-99 to the U.S.
Building One, designed as a private, nuclear technology facility, will be the location for employee training and the development of operating history with equipment while the main SHINE production facility is under construction. It eventually will become a technology development center.
The country, which has lacked such a source for more than 25 years, currently relies on shipments of the radioisotope from other countries, placing it at risk of shortages and supply chain issues. All Mo-99 currently utilized is derived from enriched uranium, posing risks to the environment.
"SHINE's approach is the best because it’s safer, cleaner, lower cost, and more reliable than other methods," said Pitas. "It doesn't require a 50+-year-old, highly-enriched-uranium-fueled nuclear reactor, and produces moly-99 that fits into the existing moly-99 supply chain."
JP Cullen oversaw construction, finishing the six month project three weeks ahead of schedule with zero OSHA-recordable incidents and on budget.
Buildout of the inside the 11,400 sq. ft. building is beginning now, with the facility set to house the first integrated, full-size SHINE production system this summer.
The U.S. Nuclear Regulatory Commission awarded SHINE a construction permit for the facility in 2016.
Once the facility is operational, customers, such as GE Healthcare and Lantheus Medical Imaging, will have to submit a supplemental NDA to the FDA to update their current clearance for utilizing Mo-99 produced by SHINE in their Tc-99m generators.