GE Healthcare and SHINE Medical Technologies announced today that GE’s DRYTEC Technetium-99m (Tc-99m) generator has successfully produced pharmaceutical-grade Tc-99m using SHINE’s process to produce the parent isotope, molybdenum-99 (Mo-99).

"The successful test is a proof of concept for SHINE's Mo-99 right now; once SHINE is at full manufacturing capacity, it should be able to supply approximately two-thirds of U.S. demand and approximately one-third of world demand," Rick Cornell, global SPECT manufacturing and radiopharmacy leader at GE, told HCB News. "GE sources from multiple suppliers of Mo-99, including SHINE's Mo-99, to ensure we don't have any future shortages."

Conventional production methods depend on a nuclear reactor to generate neutrons, but the SHINE system is driven by neutrons from an accelerator and those neutrons strike the uranium target and create Mo-99.
The company claims that its accelerators are safer, more affordable, and more environmentally friendly to build and operate than reactors, which depend on highly enriched uranium (HEU) and can be hazardous.

Over 40 million medical imaging exams per year — including stress tests for heart disease and bone scans to determine cancer progression — require Tc-99m. The U.S. uses half of the global supply of Mo-99 and imports all of it from nuclear reactors overseas and in Canada.

Many of those reactors are experiencing outages, which could lead to a shortage of Mo-99. Canada announced that it intended to discontinue Mo-99 production in 2016.

There are a number of U.S. companies looking for ways to commercially and safely manufacture the workhorse SPECT isotope. With support from the U.S. government, SHINE and its Wisconsin neighbor, NorthStar Medical Radioisotopes, are among the ones making the biggest headway.

GE also tested the Tc-99m in the preparation of finished radiopharmaceuticals using its Myoview kit, which is used for the preparation of Tc-99m-tetrofosmin for injection, and its Ceretec kit, which is used for the preparation of Tc-99m exametazime for injection. They found that those kits can successfully prepare Tc-99m radiopharmaceuticals.

Now that commercial and technical compatibility of SHINE’s product has been proven, the company is looking forward to receiving a Construction Permit from the U.S. Nuclear Regulatory Commission in the first quarter of 2016. After that, they will finish the construction of their manufacturing facility in Janesville, Wisconsin.

“The key will be running a safe and effective construction and commissioning process to stay on schedule, and we believe we have the strong team needed to do that,” said a spokesperson from SHINE.

The company is expecting to start commercial production in 2019.

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