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优化和扩大Ga-FAPI-46生产在模块化实验室PharmTracer平台上进行临床应用

Irene Brusa¹, Veronica Serena Cabitza¹, Stefano Emiliani¹

¹Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Nuclear medicine and biology

|February 25, 2025

概括

开发了一种优化的自动化方法来生产[68Ga]Ga-FAPI-46辐射追踪器. 这种方法提供了高产量和放射化学纯度,满足了癌症诊断的临床需求.

科学领域:

核医学是一种核医学.
放射性药物化学放射性药物化学

背景情况:

纤维细胞激活蛋白 (FAP) 向放射性追踪剂[68Ga]Ga-FAPI-46越来越多地用于PET/CT用于癌症诊断.
需要定期生产高活性[68Ga]Ga-FAPI-46来满足临床需求.

研究的目的:

优化和扩大[68Ga]Ga-FAPI-46生产的自动化方法.
为了确保高活性[68Ga]Ga-FAPI-46的方便和常规生产,使用PharmTracer模块和两个GalliaPharm发电机.

主要方法:

优化标签条件,包括前体量,酸度,缓冲 pH 和加热参数.
使用PharmTracer自动合成模块与两个GalliaPharm发电机.
评估了43项常规合成,以评估产量,纯度和质量控制参数.

主要成果:

通过40μg的前体,3mg的 Askorbic 酸,0.4M的酸盐缓冲剂 (pH4.5) 和15分钟的加热在95°C,实现了最佳的标签.
添加维生素C作为产品质量的稳定剂,在合成后3小时内添加维生素C.
在43种合成中实现了91.1 ± 3.4%的腐蚀校正产量和99.8 ± 0.3%的放射化学纯度.

结论:

成功开发了一种高效,强大的[68Ga]Ga-FAPI-46生产自动化方法.
该方法提供多次剂量,有效地解决了这种放射性药物的临床需求.
开发的过程确保了癌症诊断的高质量和可靠的供应.

关键词:

自动化生产生产自动化生产在FAPI-46中使用.-68是一种.在PET成像中使用PET成像.药物追踪器 (PharmTracer) 是一种药物追踪器.放射性药物放射性药物放射性药物

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