Strontium Validation Completed at Positron's Lubbock, Texas Facility
June 13, 2012 — Positron Corp. announced completion of its first strontium validation effort in May 2012, when Manhattan Isotope Technology (MIT), a Positron subsidiary, successfully 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. MIT has now generated the necessary data required for its drug master file (DMF) and will soon be submitting it to the U.S. Food and Drug Administration (FDA). 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. The objective of Positron's isotopes mission is to improve the reliability and increase the availability of Sr-82 supply, further advancing cardiac positron emission tomography (PET),” said Jason Kitten, president of MIT. “Positron's dedication to cardiac PET will lead the way in liberating the U.S. dependency on reactor-based isotopes, thereby reducing the need for highly enriched uranium. Sr-82 production, processing and Rb-82 PET are well-established technologies; the techniques, modalities and know-how have been available for some time, and only now, though Positron's vertically integrated strategy, a full solution is becoming a reality."
For more information: www.positron.com