BWXT Medical Ltd. has officially filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active Pharmaceutical Ingredient. Ac-225, an alpha-emitting isotope, plays a pivotal role in targeted alpha therapies (TATs), which utilize specific tumor-seeking targeting vectors to eradicate cancer cells while minimizing harm to healthy tissues.
The demand for Ac-225 is on the rise, yet there are few suppliers capable of producing substantial quantities of high purity actinium. One notable technology involves high-energy proton spallation of thorium targets, a process executed in collaboration with TRIUMF. This method favors the production of Ra-225, which can then be isolated and loaded onto a generator. Upon elution, this generator yields high purity Ac-225 devoid of the long-lived impurity Ac-227.
Jonathan Cirtain, President and CEO of BWXT Medical, expressed, “Our submission of a Drug Master File to the FDA signifies a significant milestone for our company. This step underscores our steadfast dedication to upholding quality and regulatory standards, ensuring that our medical isotopes meet the highest criteria of safety and efficacy. It reflects not only our commitment to advancing healthcare but also our readiness to assist our customers and partners in delivering crucial treatments to patients in need.”
The FDA’s role encompasses advancing public health by accelerating innovations that enhance the effectiveness, safety, and affordability of medical products, and by furnishing the public with accurate, science-based information necessary for utilizing medical products and foods to maintain and improve health. Drug master files (DMFs) serve as submissions to the FDA, offering confidential, comprehensive insights into facilities, processes, or articles utilized in the manufacturing, processing, packaging, and storing of human drug products.
An active DMF empowers clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has already been utilized in an early clinical study, and the DMF is now primed for reference to bolster later-stage clinical studies and, ultimately, new drug applications.
