Cardinal Health is dramatically expanding its production of Actinium-225 (Ac-225), a key ingredient in next-generation cancer therapies, at its Center for Theranostics Advancement (CTA) in Indianapolis.
The company has added a high-capacity production line to its Drug Master File (DMF), significantly increasing its supply of cGMP-compliant Ac-225 for investigational drug products and future commercial manufacturing.
Ac-225, an alpha-emitting radionuclide, can be paired with molecules designed to selectively target cancer cells. It is fueling a promising wave of therapies for cancers including prostate, neuroendocrine, breast, colon, melanoma, and lymphoma. Despite surging demand, clinical progress has been hampered by limited global availability.
Since launching routine Ac-225 production at scale in late 2024, Cardinal Health has quadrupled weekly output. The company plans further increases in 2026 to meet 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."
The expanded production line also boosts material availability for research and clinical trials. Cardinal Health’s Ac-225 has already supported more than 15 clinical trials worldwide, underscoring its collaboration with pharmaceutical innovators.
"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."