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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 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.

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This study was supported by Japan Agency for Medical Research and Development (AMED) programs of “Practical Research for Innovative Cancer Control (18ck0106373h0002)”. We would like to thank Editage ( for English language editing.

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Correspondence to Yukie Yoshii.

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HM and EK are employees of Nihon Medi-Physics Co., Ltd. All the other authors declare that they have no conflict of interests.

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Matsumoto, H., Igarashi, C., Kaneko, E. et al. Process development of [64Cu]Cu-ATSM: efficient stabilization and sterilization for therapeutic applications. J Radioanal Nucl Chem 322, 467–475 (2019).

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