BWX Technologies said this week it had reached a significant milestone in preparing for production and commercialization of the medical isotope molybdenum-99 (Mo-99), while acknowledging that its overall program has fallen behind schedule.
Based in Lynchburg, Va., the company is best known as a manufacturer of naval reactors and contractor for the Department of Energy. But it has aggressively joined the race to provide domestic sources of Mo-99.
Molybdenum-99 decays into another isotope, technetium-99m, which in the United States alone is used in over 40,000 medical procedures each day. It is reportedly used in roughly 85% of nuclear medicine diagnostic imaging procedures.
BWXT has developed a neutron-capture process for manufacturing Mo-99 without use of nuclear weapon-usable highly enriched uranium (HEU). Along with addressing proliferation concerns, the system would reduce waste levels and production costs in comparison to potential competitors, the company says.
On Tuesday, BWXT said it had succeeded in labeling technetium-99m generated by its Mo-99 production process with nine “cold kits” used widely across North America. Labeling involves combining the technetium-99m produced by a generator with a chemical reagent, forming a radiopharmaceutical that can be used for a patient.
“The Tc-99m that is eluted from the generator is combined with different cold kits, depending on the medical procedure being conducted,” BWXT spokesman Jud Simmons said by email Wednesday. “The cold kits contain the doses of the radiopharmaceutical that are administered to patients.”
That demonstration will be key in securing regulatory approval for BWXT’s product and then succeeding in the market, the company said.
As late as June 2018, BWXT had anticipated beginning production of Mo-99 last year at Ontario Power Group’s Darlington nuclear power plant. The isotope would be processed into technetium-99 at a facility in Kanata, Ontario, acquired in its 2018 purchase of Sotera Health’s Nordion medical isotope business.
“The multifaceted commercialization efforts continue to make solid, but slower progress than anticipated,” BWXT President and CEO Rex Geveden said Tuesday during the company’s quarterly earnings call with financial analysts.
As an example of progress, Geveden noted acceptance testing of the first hot cell to be used for processing Mo-99 at Kanata. However, delays are forcing management to revise the program schedule, he added. The company expects “to provide investors with an update as we work through the risks and approaches and detailed plans crystallize,” the CEO said.
The most challenging component of the production system is the radiopharmacy system, where the technetium-99m generators would be loaded for use, according to Simmons. BWXT has not yet filed a new drug application for the generators with the Food and Drug Administration.
“Previously, we were anticipating FDA approval for our Tc-99m generators in the first quarter of 2021,” Simmons stated. “Although our progress has been strong, we are working through some schedule delays. Due to these delays, we are re-baselining our program schedule and expect to provide an update at a later date.”
Starting in 1989, the United States for decades had no domestic commercial production of Mo-99. That left it reliant on sometimes-unreliable sources from other nations, which generally involved use of proliferation-sensitive highly enriched uranium.
A number of U.S. companies now are working toward addressing that vulnerability. NorthStar Medical Radioisotopes, based in Beloit, Wis., is already producing the isotope. On Feb. 18, the company announced that it had received FDA approval for two new filling lines at a facility in Columbia, Mo. The lines transfer a Mo-99 solution into source vessels for use by radiopharmacies with NorthStar’s RadioGenix System to manufacture the technetium-99m.
The Department of Energy’s National Nuclear Security Administration in recent years has committed upward of $160 million to help several U.S. companies stand up Mo-99 production. The most cooperative agreements for $15 million each were sealed last year with NorthStar and three other companies.
The topic briefly came up Thursday when Energy Secretary Dan Brouillette appeared before the House Appropriations energy and water subcommittee to answer questions on his agency’s $35.4 billion budget proposal for fiscal 2021.
Brouillette noted that he in January had pushed back by two years the legal ban on export of U.S. highly enriched uranium for production of medical isotopes in other nations. The deadline could have been extended by six years, he said in conversation with Rep. Mark Pocan (D-Wis.).
“I chose to move it much shorter than that that, two years, because I want to see the companies in your district and other parts around the world come up and produce this important isotope with” proliferation-resistant low-enriched uranium,” Brouillette said. “I think that’s a critical step forward for us, for our nonpro efforts, but as well as just servicing the market itself.”
