BWXT Medical Ltd, a subsidiary of US BWX Technologies and NorthStar Medical Radioisotopes have signed a Master Services Agreement to facilitate the production of actinium-225 (Ac-225), a critical medical isotope used to kill cancer cells while minimizing the impact to healthy tissues.
Jonathan Cirtain, President & CEO of BWXT Medical, stated, “This collaboration is a significant step forward in our mission to support healthcare providers and patients by providing high-quality medical isotopes. Together, we are accelerating our radium-226 target design and fabrication efforts and establishing another irradiation relationship that will enable us to expand our production of Ac-225.”
BWXT Medical will collaborate closely with NorthStar, to streamline production processes, enhance safety protocols and innovate new methods of isotope generation. This collaboration will leverage the strengths of both organisations, combining cutting-edge technology with extensive industry knowledge.
“At NorthStar, we believe we’re on the cusp of a global paradigm shift in the development and commercialisation of effective new radio-diagnostics and radiotherapies that can potentially be applied to devastating cancers and rare, complex conditions,” said NorthStar President & CEO Dr Frank. “This agreement could be instrumental to the radiopharmaceutical industry and patient health.”
BWXT Medical recently announced that it has submitted a Drug Master File (DMF) for Actinium-225 API to the US Food & Drug Administration (FDA). DMFs provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drug products.
An active DMF enables clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has been used in an early clinical study, and the DMF is now ready for reference to support later stage clinical studies and, ultimately, new drug applications.
