Building a prototype “wasn't part of the original plan,” Katrina Pitas, SHINE vice president, explained at the time, adding that, “frankly, the reason we're breaking ground on that facility instead of the manufacturing facility is that we have raised money slower than we'd intended.”

Pitas said that SHINE needed to raise more private equity before beginning construction of the full-scale manufacturing plant. Last year the company raised $18 million in private funding and was also awarded $10 million from the DOE as part of a $20 million cooperative agreement.


The smaller facility is expected to demonstrate the appeal of the full-scale production plant to potential investors.

“We'll say, 'We've already produced moly 99. Here's the technology. All we have to do is build eight more accelerators.' Also, at the same time, we're really moving toward production. It's a path that helps us serve multiple purposes, but really, it helps us get closer to [Mo-99] commercialization," Pitas said.

In March, the University of Missouri Research Reactor (MURR), along with its partners Nordion, a business of Sterigenics International, and General Atomics (GA), submitted a license amendment request (LAR) to the U.S. Nuclear Regulatory Commission (NRC) to begin making the isotope.

Calling the move a “critical step,” Nordion stated that the facility could provide “nearly half of U.S. demand for Mo-99, which currently must be imported from outside North America.”

"We will start receiving Mo-99 from MURR in mid- to late-2018," said Phil Larabie, vice president, medical isotopes for Nordion. "Filing this license amendment is a key step in our efforts to stabilize and support the nuclear medicine community in North America and beyond for decades to come."

In the June 2017 issue of DOTmed HealthCare Business News magazine Tiffany Olson, president, nuclear pharmacy services, Cardinal Health spoke about the Mo-99 challenge.

“When I started in the radiopharmaceutical industry in 2013, I was astonished at the complexity of the supply chain,” she recalled.

She also addressed the shortage issue, stating that, “the Mo-99 supply shortage in 2009 created an impetus for the industry to focus on enhancing the reliability of supply. Over the last several years, the industry has increased outage reserve capacity and added extra targets at current reactors. Generator manufacturers, downstream to reactors, have diversified their supply chains and incorporated multi-source agreements for Mo-99. Industry groups such as the Organisation for Economic Co-operation and Development (OECD) are meeting with groups to ensure reactor maintenance schedules are coordinated. Mo-99 production has become more reliable with these additional reactors and processing capacity.”

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