SBIR-STTR Award

The Department of Energy has a mission to ensure America's prosperity and security by addressing energy and environmental challenges. Radioactive isotopes are used in nuclear medicine, energy and environmental sciences and for national security. This Phase I project aims to produce domestic, economic and environmentally responsible separation process for radioactive isotopes from lanthanides - rare earth metals, particularly ytterbium and lutetium using clean and green supercritical fluids. Radioactive lutetium is a short-lived isotope used in cancer detection and therapies, with particularly positive results in gastroenteropancreatic neuroendocrine tumor therapy, which effects over 20,000 patients annually in the US. The proposed project will test the supercritical fluid separation capabilities of irradiated isotopes, providing a domestic supply for medicine. Currently, the radiopharmaceuticals are not developed in the US. Our innovative approach will reduce processing time resulting a higher specific activity of the isotopes to improve results. Conventional processes result in significant amounts of waste and acidic solvents for disposal as well as time consuming processes. This successful technology will provide radiopharmaceutical therapy, developed, produced and transported within the United States to increase access at a lower cost than currently available.

Lutetium 177 (177Lu) is a key ingredient in promising cancer treatments for gastroenteropancreatic neuroendocrine tumors, prostate cancer, and non-Hodgkin’s lymphoma. The problem is that 177Lu has a short (6.65 day) half-life and current manufacturing processes for high purity 177Lu are complex and time consuming. This includes irradiation of a target followed by complex chemical purification techniques, resulting in significant loss of the product from radioactive decay and other losses. The goal of this project is to develop an improved purification process that can deliver 177Lu faster, at lower costs and with higher efficacy, resulting in a better supply for cancer patients. This is directly related to the US Department of Energy Isotope Program’s mandate to support production of isotopes that are in short supply for research and applications and of strategic importance to the United States. The approach is the application of innovative high-pressure fluids to rapidly isolate the 177Lu. In Phase I, a chemical system was demonstrated to deliver chemical purification which exceeds the industry standard by 30%. A full-scale prototype was built and demonstrated for purification of non-radioactive lutetium. A provisional patent was filed for the technology. In the first year of Phase II, the prototype will be enhanced and automated, and process parameters will be optimized by continued testing with non-radioactive lutetium. In the second year of Phase II, the 177Lu isotope will be generated at full scale via nuclear irradiation at a partnering research institution. The radioactive material will be purified using the prototype, thereby demonstrating the entire production life cycle at full scale from beginning to end. The commercial application will be adoption of this technology by an isotope supplier to deliver a reliable supply of high-purity 177Lu for cancer treatment. Demand for this isotope is increasing rapidly, and improved manufacturing practices will be key to establishing a reliable supply for the United States.