The Monday session “Advancement in Medical Isotopes Production and Applications” of the 2020 ANS Virtual Winter Meeting was sponsored by the Isotopes & Radiation Division and co-chaired by Lin-Wen Hu of Massachusetts Institute of Technology and James Bowen of Pacific Northwest National Laboratory.
Radioisotopes produced from nuclear reactors and accelerators are widely used for medical diagnostics and cancer therapy. Technetium-99m (decay product of molybdenum-99), for example, is used in more than 80 percent of nuclear medicine diagnostic procedures. The session featured speakers who discussed the advancement and status of domestic production and applications of medical isotopes.
Mo-99 without HEU: Peter Karcz of the National Nuclear Security Administration said that the agency uses international and U.S. efforts to produce Mo-99. NNSA assists Mo-99 production facilities in various part of the world to convert to use low-enriched uranium targets, and it also is working to accelerate the establishment of commercial non-highly enriched uranium-based Mo-99 production in the United States. NNSA’s end goal is to have reliable supplies of Mo-99 produced without HEU.
Karcz added that its efforts are accomplished through inter-agency cooperation with the White House’s Office of Science and Technical Policy, the Nuclear Regulatory Commission, the Food and Drug Administration, the Centers for Medicaid and Medicare Services, and the State Department.
New facility: Greg Piefer, founder and chief executive officer of SHINE Medical Technologies, explained that his company is building an isotope production facility in Wisconsin. It will be the world’s largest such facility, Piefer noted, and will be the only privately owned large-scale fission-based irradiation plant dedicated to medicine. The facility will have an initial capacity of more than 300,000 doses per week. The start of Mo-99 production is expected to take place in the second half of 2022.
Security of supply: Ira Goldman, a senior director at Lantheus Holdings, talked about isotope supply during the COVID-19 pandemic. “The medical radioisotope supply chain demonstrated resiliency” during the pandemic, he said, adding that patients were able to receive diagnostic and therapeutic isotopes despite various challenges posed by the pandemic.
Goldman said that certain regions were impacted by reduced or rescheduled deliveries, but that global Mo-99 production continued uninterrupted.
He noted that the Mo-99 supply chain-–medical isotope target producers, research reactors, Mo-99 processing facilities, technetium-99m generator production facilities, and logistics/transportation providers-–took actions to protect workforces from COVID-19 to ensure continuity of service.
The greatest challenge, Goldman said, has been in the global transport of product from the Mo-99 and Tc-99m generators, due to the major disruptions and reductions in commercial air passenger and related cargo service.
“Security of supply of medical isotopes has been maintained by the sustained efforts of many institutions, companies, and employees during this difficult and challenging period,” he said.
The MURR research reactor: Les Foyto, associate director of reactor and facilities operations at the University of Missouri-Columbia, discussed MURR, the university’s research reactor.
Foyto said that MURR operates 24 hours a day, seven days a week, and 52 weeks a year, and is available 90 percent of the time at 10 MW power. The facility has about 200 full-time employees
“In 2019, MURR produced 33 different isotopes with 2,491 shipments to nine different countries,” he said, adding that each week MURR supplies the active ingredients for four FDA-approved drugs: Quadramet, TheraSpheres, Lutathera, and Iodine-131.
Foyto noted that MURR is the sole producer of iodine-131 and Mo-99 in North America.
DOE production: Jon Neuhoff, program manager of the isotope reactor facilities for the Department of Energy’s Office of Isotope R&D and Production (Isotope Program), explained that the Isotope Program manages the nation’s inventory of stable isotopes.
The program has the sole authority within the DOE to produce isotopes for sale and distribution (except for Mo-99, plutonium-238, and special nuclear materials for weapons).
Neuhoff said that the program produces the following medically-relevant isotopes: actinum-225/bismuth-213, actinum-227, astatine-211, cobalt-60, copper-67, iron-52, lutetium-177, lead-212/bismuth-212, radium-223, thorium-227, thorium-228/radium-224, strontium-89, strontium-90, rhenium-188, yttrium-86, yttrium-88, and zinc-65.