Fully automated dual-run manufacturing of [11C]PIB on FASTlab

IF 3.6 4区医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

Nuclear medicine and biology Pub Date : 2023-12-25 DOI:10.1016/j.nucmedbio.2023.108873

Manoj Nair , Yiu-Yin Cheung , Fei Liu , Mary Ellen Koran , Adam J. Rosenberg

引用次数: 0

Abstract

This report describes an updated, fully automated method for the production of [¹¹C]PIB on a cassette-based automated synthesis module. The method allows for two separate productions of [¹¹C]PIB, both of which meet all specification for use in clinical studies. The GE FASTlab developer system was used to create the cassette design as well as the controlling tracer package. The method takes 16 min from the delivery of [¹¹C]MeOTf to the FASTlab, or 35 min from the End of Bombardment; and reliably produces 3547 ± 586 MBq of [¹¹C]PIB in high radiochemical purity (> 98 %). This methodology increases the production capacity of radiopharmaceutical facilities for [¹¹C]PIB, and can easily produce 4 batches in a single day with limited infrastructure footprint.

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在 FASTlab 上实现 [11C]PIB 的全自动双运行制造

本报告介绍了一种在盒式自动合成模块上生产 [11C]PIB 的最新全自动方法。该方法可分别制备两种 [11C]PIB，两种产品均符合用于临床研究的所有规范。通用电气 FASTlab 显影系统被用来创建盒式设计和控制示踪剂包。该方法从[11C]MeOTf输送到FASTlab需要16分钟，或从投弹结束需要35分钟；能可靠地生产出3547 ± 586 MBq的[11C]PIB，放射化学纯度高（98%）。这种方法提高了放射性药物设施生产[11C]PIB 的能力，并能在有限的基础设施占地面积内轻松地在一天内生产出 4 批产品。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nuclear medicine and biology 医学-核医学

CiteScore

6.00

自引率

9.70%

发文量

479

审稿时长

51 days

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.