A Dallas-based company has plans to ensure a steady U.S. supply of the most commonly used medical radiotracer, utilizing an expanded Australian reactor and an innovative supply chain.
The October shutdown of a Canadian reactor left North America without a homegrown source of technetium-99, used in around 80 percent of gamma camera imaging. While the remaining production facilities across the globe can meet baseline demand in the U.S., the supply chain is fragile with reactors that require frequent maintenance or shutdowns.
However, US Radiopharmaceuticals, a subsidiary of NuView Life Sciences, has partnered with the Australian Nuclear Science and Technology Organization (ANSTO) to create a scalable supply of technetium. The partnership is leveraging a $169 million investment from the Australian government that will go towards expanded production capacity at the Open Pool Australian Lightwater reactor, an isotope production facility just outside of Sydney.
The short half-life of technetium necessitates that production and transportation are squeezed into a tight window, although NuView Chairman and CEO Paul J. Crowe believe their system will run without any hiccups.
“Our logistics are ideal; they ship everything out of Sydney and everything comes into Dallas via Qantas Airlines,” said Crowe. “The cost is lowered because you have a big commercial air carrier where the alternative is flying FedEx to Boston or another hub.”
The product will be comparably priced with competitors like Mallinckrodt Pharmaceuticals and Lantheus Medical, both of whom import their isotopes from Europe. Crowe says the strong relationship with ANSTO and the scalable supply chain will give his firm the ability to supply 90 percent of North America’s technetium demand in the case of a shortage.
US Radiopharmaceuticals plans to introduce its technetium-99 product in early 2018, according to Crowe. While a shortage before then could disrupt the flow of the radiotracer to U.S. hospitals and clinics, he believes it could speed the regulatory process.
“The regulatory agencies don’t want to see a supply chain problem, they are charged with patient safety but they also want to make sure there’s plenty of product,” he said. “If a shortage did occur, that would provide us with a little more ammunition to go in and request a fast track approval process from agencies, so long as we’re in compliance with the build out and manufacturing processes.”