Note: This story was last updated at 12:45 p.m.
Coquí Radio Pharmaceuticals Corporation announced Wednesday that it could invest $500 million at a new medical isotope production facility at the Heritage Center in west Oak Ridge.
The facility could start production in late 2025, said Carmen Bigles, founder and chief executive officer of Coquí Radio Pharmaceuticals.
The U.S. Department of Energy has transferred land for the facility and provided research support through the national laboratories, the company said in a press release Wednesday morning.
Coquí’s facility will produce medical isotopes that diagnose and treat diseases, primarily molybdenum-99 (Mo-99), which is used in 18 million medical procedures a year in the U.S., the press release said.
The facility will provide more than 200 high-paying, permanent jobs, Coquí said.
The Heritage Center site, known as Duct Island, was transferred to Coquí in late September. Heritage Center is the former K-25 site.
“The DOE land transfer to Coquí of 206 acres in the Heritage Center Industrial Park places the company in a strategic location adjacent to federal research assets, Oak Ridge National Laboratory and the Y-12 National Security Complex,” the company said.
The project will need to be licensed by the U.S. Nuclear Regulatory Commission.
“Now that the site has been selected and the facility will be built in Oak Ridge, the Coquí team is gearing up to begin its environmental report and NRC construction permit application,” Bigles said. “The submission of the application should occur sometime in mid-2020.”
Once it begins operating, the facility will be the first of its kind in the United States, which currently relies on imports to meet its Mo-99 needs, the press release said. The most widely used medical isotope in the world, Mo-99 is relied on to diagnose and treat diseases including brain, heart, lung, liver, renal, oncologic, and muscle skeletal diseases.
“Coquí is best positioned to meet the demand for lifesaving medical isotopes because our technology is commercially proven and is used in the current supply chain,” Bigles said in the press release. The design of Coquí’s facility is being led by INVAP, the world’s leading designer and developer of medical isotope production facilities. Coquí has an exclusive license with INVAP to use its technology in the United States.
“Global supplies of Mo-99 are becoming increasingly unreliable as facilities capable of producing the isotope age and shut down,” the press release said. “Mo-99 shortages, such as the one that occurred in November 2018, deprive patients from receiving lifesaving diagnostics and treatment. The U.S. currently has no domestic production source. The Coquí facility is expected to be fully operational in 2025 and will provide more than 200 high-paying, permanent jobs.”
In the press release, Bigles said the land acquisition provides many advantages.
“Oak Ridge is home to several DOE and Tennessee Valley Authority nuclear facilities, providing a strong nuclear and engineering workforce,” Bigles said. “By growing our company in Oak Ridge, we can leverage world-class research assets like Oak Ridge National Lab and the Y-12 National Security Complex.”
The press release said DOE has provided further support for the Coquí facility through research funding. These funds support Coquí’s partnership with ORNL and Y-12 to conduct further research on Mo-99 target plate fabrication and qualification. Coquí’s decision to locate its production facility in Oak Ridge makes its collaboration with ORNL and Y-12 easier and more efficient, the press release said.
“This research partnership is critical and supports our efforts to obtain Nuclear Regulatory Commission and Food and Drug Administration approvals for the facility,” Bigles said in the press release. “The sooner we can begin producing U.S.-made Mo-99, the sooner we can minimize our dependency on foreign imports to meet critical U.S. medical needs.”
At one time, the company had planned a $330 million medical isotope production facility in Alachua, near Gainesville, Florida. But a Florida newspaper, the Gainesville Sun, reported in October 2016 that Coquí would build the manufacturing facility in Oak Ridge, rather than relocating to Alachua in part because of the DOE land and the opportunity to work with Oak Ridge National Laboratory.
There has been a continued emphasis among federal officials, including during recent congressional budget hearings, on being able to produce Mo-99 in the United States.
Officials advocating for the proposed Oak Ridge Airport at the Heritage Center have cited Coquí and its need to fly out short-lived medical isotopes as one reason to build the airport in west Oak Ridge.
Coquí Pharma was founded in September 2009 with a mission to create a commercially scalable and reliable supply of molybdenum-99, which is used in more than 18 million medical procedures to treat and diagnose disease each year in the U.S. For more information, visit http://coquipharma.com/.
See the company’s press release here.
More information will be added as it becomes available.
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