News | Radiopharmaceuticals and Tracers | March 03, 2023

NorthStar is poised to be the first commercial-scale producer of rare radioisotope, in chronic short supply, for use in clinical studies and patient healthcare to treat many types of cancer 

100-foot crane lifting Rhodotron TTE-300 HE Electron Beam Accelerator at NorthStar Medical Radioisotope's new Ac-225 Production facility in Beloit, Wisconsin (Photo: Business Wire)

100-foot crane lifting Rhodotron TTE-300 HE Electron Beam Accelerator at NorthStar Medical Radioisotope's new Ac-225 Production facility in Beloit, Wisconsin (Photo: Business Wire) 

March 3, 2023 — NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, announced that it has achieved a major milestone in its efforts to deliver commercial-scale production of the scarce therapeutic radioisotope actinium-225 (Ac-225). A custom-built IBA Rhodotron TT 300-HE (High Energy) electron beam accelerator has been delivered to NorthStar’s new Ac-225 Production facility in Beloit, Wisconsin and installed in a specially designed building. This state-of-the-art facility will be dedicated exclusively to the production of non-carrier added (n.c.a.) Ac-225 and is part of NorthStar’s expansion plan to ensure scalable, reliable and environmentally preferable production of Ac-225 for treatment of patients with cancer and other serious diseases. 

Ac-225 is a high energy alpha-emitting radioisotope of increasing interest by the medical community for use in clinical studies that use targeted radiopharmaceutical therapy (RPT). RPT combines specialized molecules with therapeutic radioisotopes, such as Ac-225 or copper-67(Cu-67), to directly target and deliver therapeutic doses of radiation that destroy cancer cells in patients with serious disease, while sparing healthy tissue. Availability of Ac-225 for clinical trials, research, and eventual commercialized products is inadequate, due to limitations of current production technologies. Successful commercial-scale production is critical to ensuring that this promising therapeutic option is available for patients. 

NorthStar is positioned to be the first commercial-scale producer of the therapeutic radioisotopes Ac-225 and Cu-67 and is applying its expertise in production technology to provide robust, reliable supply for advancing clinical research and supplying commercial radiopharmaceutical products. The electron accelerator technology will produce high purity, non-carrier added (n.c.a.) Ac-225 that is free of long-lived radioactive byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals, health systems and other healthcare institutions. 

“Delivery of this electron beam accelerator brings NorthStar Medical Radioisotopes a step closer to commercial production of Ac-225 and marks a tremendous milestone event for NorthStar, nuclear medicine and patient health,” said Stephen Merrick, Chief Executive Officer, NorthStar Medical Radioisotopes. “NorthStar is applying the same development expertise to our therapeutic radioisotope programs that positioned us at the forefront of U.S. radioisotope production thanks to our novel Mo-99 program. We are utilizing innovative electron beam accelerator technology, which is one of the most effective methods of producing medical radioisotopes such as Ac-225 and Cu-67. The process is highly efficient, non-uranium based and environmentally preferable, and will provide scalable, flexible production capacity. With delivery and installation of this accelerator, progress on the new Ac-225 Production facility is well underway, with initial production of radiochemical grade Ac-225 planned for late 2023/early 2024. We expect to submit a Drug Master File to the FDA in 2024, which, upon acceptance, will allow NorthStar to provide cGMP grade Ac-225. NorthStar has n.c.a. Ac-225 production capacity to meet all customer needs from research through commercialization, and we can readily scale up further as market demand increases.” 

Mr. Merrick continued, “We are extremely appreciative to all of our partners and stakeholders for their support in achieving this milestone: our private commercial investors, NorthStar’s committed and talented employees, our supply chain partners and our customers. In particular, we are grateful for the important contributions of IBA, (Ion Beam Applications S.A., EURONEXT), a leading global supplier of accelerators that is focused on bringing integrated and innovative solutions for the diagnosis and treatment of cancer, continues to be a tremendous collaborator in this effort, and we look forward to additional projects with them in the United States and globally. This is a very exciting time for NorthStar and those involved in nuclear medicine. We all share a vision to accelerate the future of patient health by providing innovative solutions to ensure robust, reliable access to radioisotopes that can make a positive difference in healthcare for people around the world.” 

For more information: 

Related Radioisotope Content:     

NorthStar Medical Radioisotopes Announces Supply Agreement with Aktis Oncology, Inc. for Alpha-Emitting Therapeutic Radioisotope Actinium-225 (Ac-225)   

NorthStar Medical Radioisotopes and Convergent Therapeutics Announce Supply Agreement for Therapeutic Radioisotope Actinium-225 (Ac-225)     

Update on HFR Reactor Outage – Medical Isotope Supply Returning to Normal     

Update on Unplanned Outage of the HFR Reactor     

SNMMI Issues Alert That HFR Outage Will Impact Isotope Supply     

NorthStar Medical Radioisotopes Advances Focus on Therapeutic and Specialized SPECT Radiopharmaceuticals     

How Nuclear Fusion is Revolutionizing Medical Isotope Production     

FDA Approves Additional Molybdenum-99 (Mo-99) Filling Lines at NorthStar Medical Radioisotopes     

Medical Isotope Industry Opposes Export of Highly Enriched Uranium for IRE     

IBA and NorthStar Medical Radioisotopes Expand Collaboration to Enable Global Availability of Tc-99m  


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