Good practices for 89Zr radiopharmaceutical production and quality control

IF 4.4 Q1 CHEMISTRY, INORGANIC & NUCLEAR
Thomas Erik Wuensche, Serge Lyashchenko, Guus A. M. S. van Dongen, Danielle Vugts
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引用次数: 0

Abstract

Background

During the previous two decades, PET imaging of biopharmaceuticals radiolabeled with zirconium-89 has become a consistent tool in preclinical and clinical drug development and patient selection, primarily due to its advantageous physical properties that allow straightforward radiolabeling of antibodies (89Zr-immuno-PET). The extended half-life of 78.4 h permits flexibility with respect to the logistics of tracer production, transportation, and imaging and allows imaging at later points in time. Additionally, its relatively low positron energy contributes to high-sensitivity, high-resolution PET imaging. Considering the growing interest in radiolabeling antibodies, antibody derivatives, and other compound classes with 89Zr in both clinical and pre-clinical settings, there is an urgent need to acquire valuable recommendations and guidelines towards standardization of labeling procedures.

Main body

This review provides an overview of the key aspects of 89Zr-radiochemistry and radiopharmaceuticals. Production of 89Zr, conjugation with the mostly used chelators and radiolabeling strategies, and quality control of the radiolabeled products are described in detail, together with discussions about alternative options and critical steps, as well as recommendations for troubleshooting. Moreover, some historical background on 89Zr-immuno-PET, coordination chemistry of 89Zr, and future perspectives are provided. This review aims to serve as a quick-start guide for scientists new to the field of 89Zr-immuno-PET and to suggest approaches for harmonization and standardization of current procedures.

Conclusion

The favorable PET imaging characteristics of 89Zr, its excellent availability due to relatively simple production and purification processes, and the development of suitable bifunctional chelators have led to the widespread use of 89Zr. The combination of antibodies and 89Zr, known as 89Zr-immuno-PET, has become a cornerstone in drug development and patient selection in recent years. Despite the advanced state of 89Zr-immuno-PET, new developments in chelator conjugation and radiolabeling procedures, application in novel compound classes, and improved PET scanner technology and quantification methods continue to reshape its landscape towards improving clinical outcomes.

89Zr 放射性药物生产和质量控制的良好做法。
背景:在过去的二十年中,用锆-89 辐射标记的生物制药 PET 成像已成为临床前和临床药物开发及患者选择的一种常用工具,这主要是由于锆-89 具有良好的物理特性,可以直接对抗体进行辐射标记(89Zr-immuno-PET)。它的半衰期长达 78.4 小时,因此在示踪剂的生产、运输和成像的物流方面具有灵活性,可以在较晚的时间点进行成像。此外,它的正电子能量相对较低,有助于进行高灵敏度、高分辨率的 PET 成像。考虑到在临床和临床前环境中使用 89Zr 对抗体、抗体衍生物和其他化合物类别进行放射性标记的兴趣与日俱增,迫切需要获得有价值的建议和指南,以实现标记程序的标准化:本综述概述了 89Zr 放射化学和放射性药物的主要方面。详细介绍了 89Zr 的生产、与常用螯合剂的共轭、放射性标记策略以及放射性标记产品的质量控制,并讨论了替代选择和关键步骤,以及故障排除建议。此外,还介绍了 89Zr 免疫 PET 的历史背景、89Zr 的配位化学以及未来展望。本综述旨在为初涉 89Zr 免疫正电子发射计算机断层成像领域的科学家提供快速入门指南,并为当前程序的协调和标准化提出建议:89Zr具有良好的PET成像特性,其生产和纯化过程相对简单,因此非常容易获得,再加上合适的双功能螯合剂的开发,使得89Zr得到了广泛应用。近年来,抗体与 89Zr 的结合,即 89Zr-immuno-PET 已成为药物开发和患者选择的基石。尽管 89Zr-immuno-PET 技术已经非常先进,但螯合剂共轭和放射性标记程序、新型化合物的应用以及 PET 扫描仪技术和定量方法的改进等方面的新发展仍在不断重塑其前景,以改善临床疗效。
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
CiteScore
7.20
自引率
8.70%
发文量
30
审稿时长
5 weeks
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