Every year, doctors order as many as 40 million medical imaging scans that require a radioactive isotope called technetium-99m (Tc-99m). The scans help them diagnose cancer, heart disease and other serious maladies.
Tc-99m comes from molybdenum-99 (Mo-99), another isotope. Mo-99 is typically produced in nuclear reactors, but many of those reactors are working beyond their planned life spans, going offline and at times causing shortages that can severely delay medical imaging scans.
Moreover, the United States, which accounts for half of the world’s demand for Mo-99, imports all of its Mo-99 from reactors abroad. The reliance on isotopes from only a few reactors around the world has made the Mo-99 supply chain a delicate one. The end result: a steadily growing need to find alternative sources of Mo-99.
GE Healthcare and SHINE Medical Technologies have done just that: they tested and verified a new way to manufacture Mo-99. Jan Makela, general manager of core imaging for GE Healthcare, and his team went out to the industry to find another source of Mo-99 that could help break through the bottleneck. SHINE answered with an innovative new way to produce Mo-99 in the United States, without relying on a nuclear reactor. The GE Healthcare team shipped in SHINE’s Mo-99 and tested it by processing it inside GE Healthcare DRYTEC generators to yield Tc-99m.
The team then used the Tc-99m to prepare two finished radiopharmaceuticals, confirming that SHINE’s Mo-99 could be an alternative source for their production.
Here's why it matters: When a batch of Mo-99 arrives at a hospital or nuclear pharmacy, it decays to the medically usable isotope Tc-99m. Doctors then prepare imaging agents compounded with Tc-99m for injection into the body to highlight organs or specific parts of the body using medical equipment such as SPECT (single-photon emission computed tomography) cameras. These imaging procedures can assist in assessing heart disease or determining the stage of bone cancer progression by highlighting abnormalities picked up by the scan.
With a relatively short shelf life — 2.75 days for Mo-99, and only six hours for Tc-99m — suppliers must quickly manufacture, ship and deliver generators to make sure that patients can get the scans they need. There’s no “stocking up” of these materials to prepare for future shortages, so delays in production immediately impact the healthcare facilities that need a continuous supply. “Our customers — clinics, hospitals and imaging specialists — rely on a secure supply of technetium-99m from Mo99 to make sure that they can conduct important diagnostic imaging scans their patients need,” Makela said. “We are working hard to make this key isotope readily available and cost-effective for them.”
SHINE’s alternative Mo-99 can be integrated into today’s Tc-99m production methods without making changes to the process. The company is expected to begin commercial production in 2019 using this new process, and expects to be able to produce enough Mo-99 to supply two-thirds of the country’s need.