Kendall E Barrett, Jason C Mixdorf, Johan Svedjehed, Jeanine Batterton, Jennifer Eagleburger, Yongjun Yan, Katherine Gagnon, Eduardo Aluicio-Sarduy, Todd E Barnhart, Jonathan W Engle
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Solid phase extraction chromatography-based radiochemical isolation of cyclotron-produced 51Mn from enriched 54Fe targets.
We report DGA extraction chromatography isolation of 51Mn from isotopically enriched 54Fe. The method has been studied in semi-automated and automated realizations. The former achieves a decay corrected radiochemical yield of 78 ± 1 % (n = 3) and a separation factor of (1.0 ± 0.8) x 105 (n = 3). With GE HealthCare's Solid Target Platform (STP) and FASTlab the latter, fully automated method achieves a decay corrected radiochemical yield of 87 ± 1 % (n = 3) and a separation factor of (2.7 ± 0.9) x 104 (n = 3). Both setups efficiently isolate cyclotron-produced 51MnCl2 suitable for human administration as determined by developed Chemistry, Manufacturing, and Controls (CMC) acceptance criteria, and support exploration of 51Mn as a clinical diagnostic tool.
期刊介绍:
Nuclear Medicine and Biology publishes original research addressing all aspects of radiopharmaceutical science: synthesis, in vitro and ex vivo studies, in vivo biodistribution by dissection or imaging, radiopharmacology, radiopharmacy, and translational clinical studies of new targeted radiotracers. The importance of the target to an unmet clinical need should be the first consideration. If the synthesis of a new radiopharmaceutical is submitted without in vitro or in vivo data, then the uniqueness of the chemistry must be emphasized.
These multidisciplinary studies should validate the mechanism of localization whether the probe is based on binding to a receptor, enzyme, tumor antigen, or another well-defined target. The studies should be aimed at evaluating how the chemical and radiopharmaceutical properties affect pharmacokinetics, pharmacodynamics, or therapeutic efficacy. Ideally, the study would address the sensitivity of the probe to changes in disease or treatment, although studies validating mechanism alone are acceptable. Radiopharmacy practice, addressing the issues of preparation, automation, quality control, dispensing, and regulations applicable to qualification and administration of radiopharmaceuticals to humans, is an important aspect of the developmental process, but only if the study has a significant impact on the field.
Contributions on the subject of therapeutic radiopharmaceuticals also are appropriate provided that the specificity of labeled compound localization and therapeutic effect have been addressed.