The Department of Energy on Wednesday announced plans to provide another $60 million in funding for domestic commercial programs to produce the medical isotope molybdenum-99 (Mo-99).
The department’s semiautonomous National Nuclear Security Administration (NNSA) intends to begin negotiations with four companies on cooperative agreements, each worth as much as $15 million. The anticipated recipients are: NorthStar Medical Radioisotopes, of Beloit, Wis.; SHINE Medical Technologies, of Janesville, Wis.; Northwest Medical Isotopes, of Corvallis, Ore.; and Niowave, of Lansing, Mich.
As many as seven companies bid on the agreements when the procurement process began last year. An independent panel of technical specialists assessed the plans and selected the four companies.
“SHINE is happy the DOE independent review panel has once again validated our technical approach and we’re proud to be considered for a new cooperative agreement,” spokeswoman Katrina Pitas said by email Wednesday. The company would use the funding for construction of its isotope production plant, which is due to begin this spring.
All recipients would be required to match the NNSA funding.
Negotiations on a cooperative agreement generally last six months, the NNSA said Friday. The goal will be to define the specific functions that would be funded under the deal. The money has already been appropriated by Congress, so up to $15 million will be available immediately upon signing of each agreement. The funds would be distributed over the course of the agreements, which are good for up to three years.
“We’re excited to go to the next step and work with the NNSA,” Carolyn Haass, chief operating officer at Northwest Medical Isotopes, told RadWaste Monitor on Thursday.
The companies are working to re-establish U.S.-based manufacturing of Mo-99, which last existed in 1989. The United States has since then relied on foreign supplies, which are at risk of interruption and shortates.
To meet the NNSA’s standards, the companies’ production methods must not use nuclear weapon-usable highly enriched uranium and must show they can scale up to 3,000 6-day curies of Mo-99 per week.
Molybdenum-99 decays into the isotope technetium-99m, which is used extensively around the world in a range of medical services, including diagnosing heart disease and cancer.
The NNSA in 2010 issued four cooperative agreements to Mo-99 projects managed by NorthStar, SHINE, and General Atomics. Each cost-sharing agreement was worth $25 million; NorthStar received two agreements for separate production approaches. General Atomics ultimately abandoned its program after one of its partners, Nordion, withdrew.
SHINE this spring plans to begin building its commercial-scale facility in Janesville that would use non-reactor, accelerator-based technology to produce molybdenum-99. The first tranche of NNSA funding supported its technology advancement and demonstration process, along with designing the plant and the application for a Nuclear Regulatory Commission construction permit.
New funding would help pay for construction, Pitas said. The company expects to file its application for a NRC operating license by the end of June and to begin commercial production of the isotope in 2021 – eventually, SHINE says, providing more than one-third of worldwide need for molybdenum-99.
NorthStar Radioisotopes has received the majority of $50 million previously pledged by the NNSA to support development and regulatory approval of two Mo-99 production methods: neutron capture and accelerator-based. It has already begun producing the isotope through its U.S. Food and Drug Administration-approved RadioGenix System.
The company, in a statement Wednesday, declined to say how it might use new funding from the NNSA: “The announcement states we will be in negotiations with NNSA related to any potential award for several months. If an award is made to NorthStar at the end of those negotiations, we will then be able to discuss how that award fits into our overall Mo-99 programs.”
Following NRC approval, Northwest Medical Isotopes last year broke ground on its production plant. Construction is expected to be completed in 2020, followed by the start of operations in 2021. Low-enriched uranium targets irradiated at partnering reactors would be sent to the facility for isotope recovery and uranium recycling.
Niowave, which already produces other medical isotopes, said Friday it has already built research and development and production facilities. It is scaling up its system, using a superconducting electron linear accelerator, and hopes to shift from the R&D facility to production in the next 12 months. The company hopes to be able to meet 30 percent to 50 percent of U.S. need within five to seven years, spokesman Jerry Hollister said by email.
“The funding will be used to continue to scale our process and continue the regulatory process with both the Nuclear Regulatory Commission and the Food and Drug Administration,” Hollister said.
