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Process development of [64Cu]Cu-ATSM: efficient stabilization and sterilization for therapeutic applications

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Hypoxia plays an important role in tumor prognosis. [64Cu]Cu-ATSM, a hypoxia-targeted radioactive agent, reportedly shows antitumor effect in vivo. For clinical application, [64Cu]Cu-ATSM must be manufactured at high concentrations to… Click to show full abstract

Hypoxia plays an important role in tumor prognosis. [64Cu]Cu-ATSM, a hypoxia-targeted radioactive agent, reportedly shows antitumor effect in vivo. For clinical application, [64Cu]Cu-ATSM must be manufactured at high concentrations to allow the administration of a therapeutic dose with safe intravenous bolus injection. Fifteen radical scavengers were tested to stabilize [64Cu]Cu-ATSM against radiolysis, and sodium l-ascorbate was selected. The optimal sterilization membrane filter was evaluated from polyvinylidene fluoride (PVDF), polyether sulfone, and mixed cellulose esters; PVDF showed the most efficient radiochemical yield after filtration. The proposed procedures can be used for the practical manufacturing of [64Cu]Cu-ATSM for therapeutic use.

Keywords: sterilization; 64cu atsm; atsm efficient; development 64cu; process development; atsm

Journal Title: Journal of Radioanalytical and Nuclear Chemistry
Year Published: 2019

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