GMP validation of actinium-255 radiopharmaceutical

CIRC collaboratively developed and GMP validated a novel Ac 225 based radiopharmaceutical, representing a significant scientific and translational milestone. In parallel, CIRC supported the sponsor with regulatory activities, including contributions to the FDA filing process. The radiopharmaceutical demonstrated high radiochemical purity, stability, and reproducibility, thereby establishing a robust and reliable manufacturing process for alpha emitter therapeutics. This work also resulted in a peer reviewed publication, co authored by CIRC, entitled Development of [225Ac]Ac LNC1011 for targeted alpha radionuclide therapy of prostate cancer (European Journal of Nuclear Medicine and Molecular Imaging, 2025). Collectively, these achievements position the institution to support external translational and clinical partners, strengthen the national alpha therapy ecosystem, and enhance CIRC’s attractiveness for future research, development, and funding opportunities.