Electron Beam Accelerator Will Scale Production of Ac-225
Under a new contract, NorthStar Medical Radioisotopes will purchase a third Rhodotron TT300 HE electron beam accelerator from IBA. NorthStar’s proprietary process for the production of actinium-225 (Ac-225) will use IBA’s Rhodotron accelerator to enable commercial-scale n.c.a. Ac-225 production that is free of long-life radioactive byproducts associated with other production methods.
N.c.a. Ac-225 is an important therapeutic radioisotope that is in highly limited supply and for which no commercial-scale production technology currently exists. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology.
NorthStar previously purchased two Rhodotron accelerators from IBA for its newly completed molybdenum-99 (Mo-99) production facility. NorthStar is positioned to be the first commercial-scale producer of Ac-225 by applying its production technology expertise to provide reliable supply for advancing clinical research and supplying commercial radiopharmaceutical products.
“We look forward to continuing to work with IBA, who have shown extensive commercial expertise and excellent performance in delivering electron beam accelerators for our Mo-99 production expansion project,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “NorthStar is at the forefront of US radioisotope production as the only commercialized producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99). We are applying that same development expertise to rapidly advance large-scale availability of the therapeutic radioisotope Ac-225 for use in oncology and other indications, and we are excited about its potential in these disease areas.”
“We are delighted to sign this latest contract with NorthStar Medical Radioisotopes and to continue to deliver innovative solutions for reliable radioisotope supply. IBA’s Rhodotron accelerators provide the most advanced electron accelerator technology in the world, and we are excited for the opportunity to create new therapeutic radioisotopes such as Ac-225. With its radiotheranostic capabilities, combining targeted diagnosis and therapy, we believe that this radioisotope has significant potential in the treatment of cancer,” said Olivier Legrain, Chief Executive Officer of IBA.
The final stage of facility design is underway for NorthStar’s state-of-the-art Therapeutic Radioisotope production facility, which will be exclusively dedicated to Ac-225 production, with construction scheduled to begin in early 2022. Initial production of Ac-225 is planned for late 2023, and a Drug Master File will be submitted to the FDA in 2024.
Ac-225 is a high energy alpha-emitting radioisotope for extensive use in clinical studies of targeted radiopharmaceutical therapy (RPT). RPT combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while minimizing undesired dose to adjacent cells in patients.