A New Evaluation of Recycling of the Cardiac Imaging Agent, Strontium-82,from spent Strontium-82/Rubidium-82 Generators

The strontium-82/rubidium-82 biomedical generator (brandname Cardiogen) provides a radioactive, positron emitting tomography (PET) isotope, used for myocardial perfusion imaging. The only indigenous, US, manufacturers of active pharmaceutical ingredient (API) grade strontium-82(Sr-82) parent material are Los Alamos (LANL) and Brookhaven National Laboratories (BNL). Manhattan Isotope Technology has identified an opportunity whereby a private, non-government entity, can also become a Sr-82 supplier, decreasing the manufacturing burden on the US government, through commercialization of patented LANL/DOE strontium-82 production technology. LANL has previously supplied Sr-82 as an API from the recycling of expired strontium-82/rubidium-82 generators. The objective of this Phase I project is to re-evaluate the patent on the spent generator recycling process, make quality and waste reduction improvements, and submit a new Drug Master File to the US FDA on behalf of Manhattan Isotope Technology LLC. Manhattan Isotope will also concurrently define the unique facility and infrastructure requirements for its own independent generator recycling facility and submit to the Office of Science SBIR/STTR Phase II call for funding assistance. . Commercial Applications and Other Benefits: The commercial applications and public benefit of this technology are easily measured. There are currently two large Sr-82 API manufacturers (LANL and BNL) and one Sr-82 drug manufacturer (GE Healthcare) in the US. In addition, there is one other Sr-82 drug manufacturer in Canada which supplies US hospitals. All of these manufacturers would be interested in another supplier of API Sr-82. There is currently a shortage of medical radioisotopes in North America due to production problems of another medical radioisotope technetium-99m. Technetium-99m is a versatile medical radioisotope and is used in most nuclear imaging procedures including cardiac. The production problem will take years to resolve and in the case of heart imaging, physicians can and are turning to Sr-82 as a viable alternative. Another public benefit of this technology is that as another US supplier of Sr-82 were to come online it would lift some of the production burden off the US labs allowing them to concentrate on research and development of new radioisotopes where their unique facilities are needed most.