DUBLIN, Ohio – Cardinal Health has announced a significant expansion of its Actinium-225 (Ac-225) production capabilities at the company's Center for Theranostics Advancement (CTA) in Indianapolis, Indiana. The addition of a high-capacity production line to its Drug Master File (DMF) will substantially increase Cardinal Health's supply of cGMP-compliant Ac-225 for use in investigational therapeutic drug products and future commercial manufacturing novel therapies.
Ac-225 is an alpha-emitting radionuclide that can be linked to molecules like those designed to selectively target cancer cells. New, cutting-edge Ac-225 drug products are being developed and are becoming an increasingly promising new class of therapies for cancers including prostate, neuroendocrine, breast, colon, melanoma, and lymphoma. Despite growing demand, worldwide clinical progress has been slowed by limited availability.
Since announcing routine Ac-225 production globally at scale at the end of 2024, Cardinal Health has quadrupled its weekly output. The company expects to continue increasing production capacity in 2026, supporting the rapidly growing global demand for targeted alpha therapies.
"Expanding our Ac-225 production capacity is a critical step forward for the industry and for patients," said Shane Thrasher, Vice President of Radiopharmaceutical Manufacturing, Cardinal Health Nuclear & Precision Health Solutions. "As targeted alpha therapies progress through clinical trials, reliable access to Ac-225 remains essential. This expanded capacity strengthens our ability to meet customer needs today while preparing for significantly larger commercial volumes that may occur in the coming years."
Cardinal Health's expanded production increases access to material for research and clinical development. To date, Cardinal Health's Ac-225 has supported more than 15 clinical trials worldwide, reflecting broad engagement with pharmaceutical innovators advancing targeted alpha therapies.
"The reliable availability of Ac-225 is essential for advancing targeted alpha therapies and enabling innovation in clinical research," said Eric Bischoff, Chief of Product Development and Operations at RayzeBio (a Bristol Myers Squibb Company). "Cardinal Health's commitment to expanding production capacity helps ensure a more robust supply chain, accelerating our ability to drive progress and deliver new treatment options to patients."
Cardinal Health has supported regulatory applications for cGMP-compliant Ac-225 for customers across multiple regions worldwide.
For more information, or to secure cGMP-compliant Ac-225 supply, visit us here.
