Lansing, MI. – Ionetix, a leading cyclotron technology innovator, isotope producer and radiopharmaceutical manufacturer, announced today that the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new production facility located in Lansing, Michigan.
This facility will be the first commercial facility in the U.S. dedicated exclusively to the production and supply of alpha-emitting radionuclides, Actinium-225 (Ac-225) and Astatine-211 (At-211), which are both being used to develop new Targeted Radionuclide Therapies to treat various types of cancer. The materials license comes just as Ionetix is in the process of completing the installation of a 30 MeV cyclotron at the facility that will be used to produce these radionuclides.
“Attaining the NRC materials license is a significant milestone for our alpha isotope program”, said David Eve, VP Medical Affairs. “The Material License will enable us to proceed with commissioning our first cyclotron to produce alpha-emitting radionuclides by the end of 2022.” Work is already underway to extend the building where a second cyclotron will be installed that will provide manufacturing redundancy and increased production capacity to meet growing demand.
The NRC Materials License authorizes Ionetix to manufacture and possess radiochemicals, including radioisotopes Radium-226, Actinium-225, Astatine-211, and other byproduct materials. The Material License also authorizes packaging and distribution of manufactured radioactive materials for medical use to authorized recipients.
Ionetix expects the Lansing facility to be fully operational in 2023 and ready to supply high-purity, non-carrier-added (n.c.a.), GMP grade Ac-225 and At-211. Ionetix plans to file a Drug Master File (DMF) for both Ac-225 and At-211 by mid-2023.
IONETIX is a US-based cyclotron and technology company founded in 2009. Utilizing a proprietary cyclotron technology platform, IONETIX is focused on developing innovative accelerator solutions for the production and distribution of radioisotopes used for both diagnostic and therapeutic radiopharmaceuticals. IONETIX offers turnkey services for the point-of-care supply of the diagnostic positron emission tomography (PET) radiopharmaceutical N-13 Ammonia. IONETIX is now expanding its services to include the supply of therapeutic alpha isotopes used in radiopharmaceuticals being developed to treat various cancers. Located in Lansing, Michigan, IONETIX is establishing the first dedicated alpha isotope manufacturing and distribution facility to produce alpha isotopes Actinium-225 (Ac-225) and Astatine-211 (At-211). Contact us to learn more.