Ionetix completes commissioning of a 30 MeV cyclotron and produces Astatine-211.
Lansing, MI, April 18, 2023 — Ionetix, a leading cyclotron technology innovator, isotope producer and radiopharmaceutical manufacturer, announced today the successful production of Astatine-211 at its new Alpha Isotope Manufacturing facility located in Lansing, Michigan.
This first-of-its-kind facility is highly specialized and dedicated exclusively to producing alpha-emitting radionuclides using cyclotrons. The company completed the installation of the first of two cyclotrons at the facility earlier this year and initial commissioning was successfully completed in March. The cyclotron is a multiparticle, 30 MeV cyclotron and, once fully optimized by Ionetix, it will be used to generating high-yields of Astatine-211 (At-211) and Actinium-225 (Ac-225).
“Producing At-211 for the first time is a significant and timely milestone for our alpha isotope program”, said David Eve, Vice President, Medical Affairs. “We are seeing an acceleration in demand for alpha-emitting radionuclides as researchers and drug developers begin to move into early phase clinical trials.”
“Increasing access to alpha-emitting radionuclides to meet growing demand requires implementing new cyclotron solutions,” said Xiaoyu Wu, PhD, Vice President of Cyclotron R&D at Ionetix. At-211 production requires a cyclotron that can accelerate alpha particles up to an energy of 29 MeV, which is a capability currently found on only a few legacy cyclotrons at academic research institutions. Therefore, in order to increase the availability of At-211 for current clinical research needs and future commercial scale, the industry requires investments in new cyclotrons with a 30 MeV alpha particle beam, which Ionetix is committed to do.
“We specifically chose a 30 MeV cyclotron to provide us with a cyclotron platform that we can fully leverage to produce alpha-emitting radionuclides, including Astatine-211.” said Wu. With extensive accelerator engineering and cyclotron operating expertise, the Ionetix team has successfully enabled the 30 MeV cyclotron for At-211 production. “We accelerated the alpha beam to the desired energy, designed and implemented a new target station to improve At-211 production and completed several At-211 production runs,” said Wu. The company now has a new cyclotron solution that will enable commercial scale production and distribution of At-211 and is currently working to do the same with Ac-225.
“This is a great first step towards establishing a secure and robust supply chain for alpha-emitting radionuclides,” said Eve. “We look forward to building upon this early success and working alongside our partners and collaborators to scale up production of both At-211 and Ac-225 to meet their needs as they work to advance the clinical development of these promising new cancer therapies.”
Ionetix expects the alpha facility to be fully operational in the fourth quarter of 2023 and ready to initiate supply of high-purity, non-carrier-added (n.c.a.), GMP grade alpha-emitting radionuclides. Ionetix currently plans to submit a Drug Master File (DMF) for Ac-225 in early 2024.
Contact us to learn more.