213Bi is a short-lived, alpha-emitting radionuclide that has been identified as an ideal isotope for the treatment of leukemia and other micrometastatic cancers. Clinical applications of this isotope are currently hindered by the limited supply of high purity 213Bi. The preferred method of supply is in the form of a generator in which 225Ac is immobilized on an ion exchange column and 213Bi is eluted as required. Current generators use organic ion exchange resins that are susceptible to radiation damage, leading to column blocking and/or the release of pyrogens and 225Ac into the 213Bi product. This proposal will design, construct and test an advanced, automated generator using radiation-resistant inorganic ion exchange materials. The generator will also produce the 213Bi product in a form suitable for the rapid synthesis of 213Bi radiopharmaceuticals. Existing generators typically produce the Bi product in HI or HCl solutions, which require multi-step processing to manufacture radiopharmaceuticals. This state-of-the art generator will fuel research in the fledgling field of alpha-emitters in cancer treatment by improving the reliability of the 213Bi generators, producing pure 213Bi in a suitable form for radiopharmaceutical manufacture and increasing the availability of 213Bi to cancer researchers.
It is envisioned that the generator will be used at medical research centers and hospitals to treat patients with cancers, such as leukemia and ovarian cancer. It will allow alpha therapy to be performed routinely with confidence that the 213Bi product will be pure and amenable for radiopharmaceutical processing. The automated generator design will also be amenable to other generator systems currently in use (e.g., 99Mo/99Tc).
