Employees of SHINE Medical Technologies huddled around the office TVs Thursday morning, watching a live webcast of the U.S. Nuclear Regulatory Commission.
It was decision day for the Monona company that has been working for four years to get approval to make a critical radioactive substance used in millions of medical procedures in the U.S. each year.
With no discussion, the four-member NRC quickly gave its unanimous approval for staff to issue a construction permit so that SHINE can build a plant in Janesville to produce the radioisotope.
“The room erupted in cheers when we heard the vote,” said SHINE CEO Greg Piefer.
Employees shared hugs, exchanged high-fives, and some even shed a few tears, said Katrina Pitas, vice president of business development.
SHINE will produce molybdenum-99, which decays into technetium-99m, an isotope used in millions of medical procedures in the U.S. each year, mainly stress tests to diagnose heart disease and bone scans to check for cancer.
There’s been no commercial production of molybdenum-99 in the U.S. since 1989, the NRC said.
Worldwide, the substance is made in aging nuclear reactors, primarily in Canada and the Netherlands, that have suffered outages in recent years, creating shortages of the isotope. The Canadian reactor is scheduled for permanent shutdown by 2018.
SHINE has developed a new way to make molybdenum-99 without using a nuclear reactor. The company says its process also uses less electricity and generates less waste.
Over the past four years, SHINE has conducted environmental and safety analyses, and the NRC has reviewed the data. NRC staff recommended approval of the permit last October.
“We’ve developed a greener, safer and cheaper way to produce these life-saving isotopes on a global scale,” Piefer said. “Once operational, we expect the Janesville facility will improve the lives of over 1 billion people over its lifetime.”
Piefer was in the UW-Madison’s nuclear engineering Ph.D program, and after getting his degree, he developed the technology, he said, and forged a partnership with the private, nonprofit Morgridge Institute for Research on the UW campus.
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“This kind of progress is a perfect example of why this university is such an economic engine for the state,” UW-Madison Chancellor Rebecca Blank said in a statement.
SHINE has said construction of the 57,000-square-foot plant — which will employ about 150 people — will begin in 2017. After some test runs are conducted, the company will have to apply for an operating license and if the NRC approves, production could start in 2019.
The estimated cost to build the facility, hire staff and start operations is more than $100 million. “We have over half of what we need lined up already,” Piefer said.
He said Thursday’s NRC vote gave him a huge sense of satisfaction. “This is something that a lot of people told me, for a long time, we’d never be able to do with new technology. And we got it done, and got it done efficiently. I couldn’t be more proud of our team,” Piefer said. SHINE currently has 25 employees.
SHINE is one of four commercial projects — three of which are in Wisconsin — chosen to work with the Department of Energy’s National Nuclear Security Administration to establish a U.S. source for molybdenum-99.
NorthStar Medical Radioisotopes, of Madison and Beloit, is developing the other two Wisconsin projects.
In the first project, NorthStar is working with the University of Missouri Research Reactor (MURR) to produce molybdenum-99. Its process involves transforming another form of molybdenum, obtained from Russia, using neutron activation, said Ed Fennell, vice president of business development. The second process will use electron accelerators, he said.
Fennell said NorthStar needs an OK from the Food and Drug Administration but not the NRC.
NorthStar has built a 50,000-square-foot plant in Beloit that will house the company’s administration and customer service and will recycle the vessels that hold the molybdenum. Eventually, some production will be done there, too.
Design and engineering will stay in Madison, and some manufacturing will continue at MURR, Fennell said.
He said NorthStar hopes to get the nod for commercial production to start by the end of 2016. The company has about 70 employees in Beloit, Madison and Columbia, Missouri.