BWXT announces new Mo-99 technology

08 May 2018

BWX Technologies Inc (BWXT) has developed an innovative process developed to manufacture molybdenum-99 (Mo-99) which it says is a breakthrough for medical radioisotope manufacturing technology. The company plans to introduce the technology by the end of 2019, subject to regulatory approvals.

 BWXT's prototype Tc-99m generator (Image: BWXT)

Featuring a patent-pending neutron capture process, BWXT's technology produces Mo-99, the parent isotope of technetium-99m (Tc-99m), which is used globally in more than 30 million medical procedures each year. BWXT's process will produce Mo-99 from natural molybdenum, rather than enriched uranium targets, which the company says eliminates fission waste, reduces environmental impacts and eliminating proliferation risk.

The Mo-99 will be housed in BWXT-manufactured Tc-99m generators, from which Tc-99m will be extracted for medical imaging and diagnostic procedures. The generators are still under development.

Tc-99m is the most widely used radionuclide for medical imaging, but as it has a short half-life.Both it and the Mo-99 it is generated from have to be used quickly once they are produced and a constant, stable supply of them is needed. Mo-99 has primarily been produced by a limited number of research reactors, many of which have been operating since the 1960s, and at times supply has been subject to disruptions and significant radioisotope shortages following outages at those reactors.

Speaking to investors yesterday, BWXT President and CEO Rex Geveden described the current Mo-99 manufacturing infrastructure, with no production at all in North America, as inefficient, globally dispersed and "extremely aged", with "burdensome" logistics. He said BWXT's breakthrough technology addresses all the problems of an expensive, unstable supply producing complex radioactive waste streams, with an associated proliferation risk.

The company anticipates entering the market through generator sales to radiopharmacies, initially focusing on the North American market where it says it will have sufficient production capacity to satisfy all Mo-99 demand.

"We are presently working to finalise agreements that will provide us with a long-term and stable irradiation supply of Mo-99 and other medical radioisotopes from multiple sources," Geveden said.

The Tc-99m generators, which will require approval by the US Food and Drug Administration (FDA), are being designed to integrate "naturally" into the existing configurations and processes of radiopharmacies to be a "plug and play" solution, with no special hardware or adaptation needed.

BWXT in April signed a definitive agreement to acquire Sotera Health's Nordion medical isotope business, to accelerate and de-risks its entry into the medical radioisotope market by adding licensed infrastructure, about 150 highly trained and experienced personnel, and two production centres. Subject to Canadian and US regulatory approvals, the acquisition is expected to close by the end of 2018.

Geveden said BWXT intends to use the assets from the acquisition to bring the Mo-99 product through the commercialisation stage and the BWXT technetium generators through the FDA approval process. It plans to adapt the two licensed production facilities included in the acquisition to process molybdenum targets and produce technetium generators.

Researched and written
by World Nuclear News