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.
Keywords[64Cu]Cu-ATSM Hypoxia Internal radiotherapy Process development Stabilization Sterilization
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 (www.editage.jp) for English language editing.
Compliance with ethical standards
Conflict of interest
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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