Positron, a molecular imaging healthcare company focused on nuclear cardiology, has completed its first strontium-82 (Sr-82) validation effort.
In May, Manhattan Isotope Technology (MIT), a Positron subsidiary, processed strontium. The internal analysis of the product demonstrates it meets the Sr-82 purity specifications required for the formulation of Sr-82/Rb-82 generators, according to the Lubbock, Texas-based company. MIT has now generated the data required for its Drug Master File (DMF) and will be submitting its DMF to the FDA shortly. The second validation sample from the Arronax Cyclotron Facility in Nantes, France, is set for strontium processing later this month.
"This is the first strontium-82 validation to be performed outside of the national laboratory arena and sets the stage for private entry into the strontium-82 radioisotope supply chain," Jason Kitten, president of MIT, commented in news release.