2021
DOI: 10.1002/jlcr.3901
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Production of [89Zr]Oxinate4 and cell radiolabeling for human use

Abstract: [89Zr]Oxinate4 is a Positron Emission Tomography (PET) tracer for cell radiolabeling that can enable imaging techniques to help better understand cell trafficking in various diseases. Although several groups have synthetized this compound for use in preclinical studies, there is no available data regarding the production of [89Zr]Oxinate4 for human use. In this report, we describe the detailed production of [89Zr]Oxinate4 under USP <823> and autologous leukocyte radiolabeling under USP <797>. The f… Show more

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Cited by 12 publications
(6 citation statements)
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References 17 publications
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“…Efforts have been made to translate 89 Zr-oxine to the clinic. The generation of GMP-compatible 89 Zr-oxine has been reported by different groups using different synthesis methods [60,97], including quality control tests for human use, such as the filter membrane integrity test, endotoxin test, and sterility test [97]. Standardization of GMP-quality 89 Zroxine production will enhance the clinical use of 89 Zr-oxine.…”
Section: Clinical Translation Perspectivementioning
confidence: 99%
“…Efforts have been made to translate 89 Zr-oxine to the clinic. The generation of GMP-compatible 89 Zr-oxine has been reported by different groups using different synthesis methods [60,97], including quality control tests for human use, such as the filter membrane integrity test, endotoxin test, and sterility test [97]. Standardization of GMP-quality 89 Zroxine production will enhance the clinical use of 89 Zr-oxine.…”
Section: Clinical Translation Perspectivementioning
confidence: 99%
“…However, there were no significant differences between 89 Zr labeled leukocytes and 111 In labeled leukocytes with respect to elution of activity or cell viability. Another group obtained similar results when using 89 Zr-oxinate4 to label human leukocytes [81]. These results are encouraging, but in vivo investigations of 89 Zr labeled leukocytes to diagnose infection are lacking.…”
Section: Zirconium-89 Labeled Leukocytesmentioning
confidence: 79%
“…The major contributors to loss of 89 Zr activity during the labelling process, which may affect the labelling yield, were the known “stickiness” of 89 Zr and its resultant adherence to surfaces of vials, etc. during labelling (Massicano et al 2020 ), as well as pH adjustment of the [ 89 Zr]Zr-Df-Bz-NCS complex. After chelation, the pH of the [ 89 Zr]Zr-Df-Bz-NCS complex must be neutralised to a pH of 7 for cell labelling.…”
Section: Resultsmentioning
confidence: 99%