DOE transfers land to Coquí Pharma for isotope production facility

Model of completed production facility

April 15, 2019
by John R. Fischer , Staff Reporter
The movement to establish domestic sources of Molybdenum-99 in the U.S. has received a boost from the U.S. Department of Energy, which has transferred a portion of land to Coquí Radio Pharmaceuticals Corporation for the location of its Medical Isotope Production facility.

The 206 acres in the Heritage Center Industrial Park of Oak Ridge, Tennessee will enable the company to produce primarily Mo-99, along with other medical isotopes for diagnosis and treatment. It also places it adjacent to federal research assets, Oak Ridge National Laboratory and Y-12 National Security Complex, which will offer research support.

“Unlike other companies that are developing technologies to produce Mo-99, Coquí Pharma's technology is the only proven, demonstrated, safe, and reliable method for commercially scalable Mo-99 production,” Carmen I. Bigles, founder and CEO of Coquí Pharma, told HCB News. “Coquí Pharma employs a previously FDA-approved process that will meet more than 50 percent of the U.S. medical demand for Mo-99.”

Used to produce technetium-99m for the diagnosis of cancers and diseases of the brain, heart, lung, liver, renal system, and muscular skeleton, foreign imports are currently the main source of Mo-99 in the U.S.

Supply chain issues, however, along with the aging and shutting down of facilities capable of producing the radiopharmaceutical, have made this source unreliable and led to Mo-99 shortages, which, in turn, have delayed access to lifesaving diagnostics and treatment for patients.

Coquí plans to utilize the resources of Oak Ridge National Lab and the Y-12 National Security Complex to conduct further research on Mo-99 target plate fabrication and qualification, with funding provided by the DOE.

Its production of Mo-99 will be fission-powered, with the company irradiating low-enriched uranium (LEU) targets in LEU-fueled open pool research reactors. Low-enriched uranium will be supplied by INVAP, an Argentinean nuclear engineering firm whose reactor is a commercially proven design for Mo-99 production and is the only fully functional research reactor built to use LEU.

The technology that Coquí Pharma plans to employ is currently used to produced FDA-approved medical radioisotopes for Australia’s Nuclear Science and Technology Organisation (ANSTO), whose OPAL research reactor was constructed by INVAP.

The organization is not the only one in the nuclear medical industry to recently receive land for the construction of a new facility, however. The City of Janesville in Wisconsin transferred 91 acres on the south side of the city this week to SHINE Medical Technologies, which completed construction and began occupying the first building of its medical isotope production facility in February 2018. The transfer this week was made as part of a tax increment financing (TIF) deal between SHINE and the city, with the land set to become home to the company’s production plant.

"This transfer represents the next step toward production of lifesaving medical isotopes, and I am grateful to the entire Janesville community for their early support and belief in SHINE," said Greg Piefer, founder and CEO of SHINE, in a statement. "We are thrilled to take ownership of the SHINE site and begin construction."

The transfer to Coquí Pharma was approved by the DOE and Congress in December 2017.

The Coquí Pharma facility is expected to be up and running by 2025, with more than 200 permanent jobs in place.

Additional steps in its plan include obtaining Nuclear Regulatory Commission and Food and Drug Administration approvals for the facility.

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