SBIR Phase I: Development of a Novel Process for the Manufacture of Iodine-131 for Medical Use

The broader impact/commercial potential of this Phase I Small Business Innovation Research (SBIR) project is to provide a domestic manufacturing source of the critical medical isotope Iodine-131 (I-131). I-131 is the primary therapeutic for several malignancies and is a key element of several new cancer treatment medicines. Despite its highly attractive features, manufacturing a high-specific activity I-131 product in conformance with strict pharmacopeial requirements is extremely challenging; the high specific activity product is only made by fissioning actinides, such as uranium. This route, although more complicated than the neutron irradiation of tellurium, produces a more favorable product in terms of ease of use and efficacy. SHINE Medical Technologies, Inc. is working on a highly innovative, fissioning technology for manufacturing manufacture several important medical isotopes here in the U.S. Due to the transitory nature of medical isotopes, they have no meaningful shelf life and cannot be stockpiled. Having a domestic supplier is critical to supply and logistics issues. Alleviating such supply concerns will considerably reduce the health risk to patients who rely on these beneficial healthcare products. With manufacturing located in the U.S., SHINE could create a number of high-technology, well-paying jobs for the economy of Wisconsin. The objectives of this Phase I research project are to better understand and, thus, control the oxidation state of iodine in an aqueous homogeneous nuclear irradiation vessel so that it may be extracted and purified for medical use. Iodine has a rich chemistry, particularly in an aqueous system and which is subjected to considerable irradiation by alpha, beta, gamma and x radiation. Without controlling its oxidation state, we cannot control its chemical speciation and, therefore, its extraction and purification from the irradiated aqueous solution. Extraction of the radioiodine is greatly complicated by the need to preserve efforts to extract the more valuable Mo-99 and eliminate impact on other safety and environmental concerns of the chemical plant (corrosion control, waste management, etc.) Accomplishing these goals will allow SHINE to become a domestic manufacturer of I-131 (as well as other medical isotopes) relieving supply issues and risks for patients and healthcare providers.