SHINE's facility in Janesville, Wisconsin, will be an integrated facility for medical isotope production, processing, and target (uranyl sulfate solution) production.
She added that the proposed process produces high-specific-activity Mo-99, compatible with existing technetium generators, without the need for a nuclear reactor. Katrina Pitas, who represented SHINE, noted that the proposed process is cost-effective and generates less nuclear waste than conventional Mo-99 production methods. The company also plans to supply I-131 and Xe-133. SHINE plans to build eight accelerator-driven operating assemblies to produce up to 4,000 six-day Ci/week of Mo-99 for U.S. SHINE, a Wisconsin-based company, plans to use deuterium/tritium accelerator technology to induce sub-critical fissioning of U-235 in an LEU uranyl sulfate solution. David Pellicciarini (Cardinal Health), who represented the largest centralized nuclear pharmacy chain in the United States, agreed that larger Cardinal Health facilities would likely be able to accommodate the RadioGenix system but added that smaller facilities within the Cardinal Health chain may be challenged. centralized nuclear pharmacies, which are typically larger than hospital-based nuclear pharmacies. He also noted that it is intended for the U.S. Harvey recognized that the RadioGenix system's footprint is much larger than today's conventional technetium generators but noted that it occupies about the same footprint as four of the conventional generators in their respective secondary shields.
CARDINAL CHAINS 99 GENERATOR
Instead, nuclear pharmacies certified to use the RadioGenix system will be equipped with the system, will be trained to use it, and will be receiving Mo-99 solution from NorthStar to load on the generator for Tc-99m elution. The RadioGenix system is not intended to be a “mobile” system similar to today's conventional technetium generators, which are shipped to nuclear pharmacies daily. He noted that the 7-year regulatory approval process compared in length with the conversion from the HEU to LEU production process, which was estimated by global producers to also take 6-7 years. As of July 2017 the company was awaiting approval of a resubmission of the NDA to start producing Mo-99.
FDA to outline a path to NDA submission in 2010 and submitted the NDA in 2013. Harvey noted that the regulatory approval process has been long: NorthStar met with the U.S. The RadioGenix Tc-99m Generating System was subject to a New Drug Application (NDA) by the U.S. and European pharmacopeia standards for Tc-99m. Tc-99m generated from the RadioGenix system meets the U.S. The RadioGenix system is a platform technology that NorthStar has used for other isotopes such as actinium/bismuth and tungsten/rhenium, and has been specifically developed for Mo-99/Tc-99m production. NorthStar has developed a new technetium generator system, the RadioGenix Tc-99m Generating System, to utilize low-specific-activity Mo-99. The Mo-99 produced by NorthStar's two processes has low specific activity and cannot be loaded directly to conventional technetium generators. NorthStar's photon-induced transmutation process could be market ready for Mo-99 production at the end of 2019. James Harvey who represented NorthStar noted that the company intends to run both of these production processes in parallel in the future because “they provide redundancy and have different strengths in terms of approaching and serving the market.” NorthStar's neutron capture process is the most advanced in terms of market readiness and could be market ready for Mo-99 production in early 2018. These are: 1.Ī neutron capture of molybdenum-98 using neutrons produced in a research reactor and 2.Ī photon-induced transmutation of molybdenum-100 using photons produced with electron accelerators.ĭr. NorthStar, a company located in Beloit, Wisconsin, is pursuing two processes to establish capabilities to supply Mo-99 to the U.S.
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