Kuhnast Bertrand, Damont Annelaure, Hinnen Françoise, Catarina Tony, Demphel Stéphane, Le Helleix Stéphane, Coulon Christine, Goutal Sébastien, Gervais Philippe, Dollé Frédéric
CEA, I2BM, Service Hospitalier Frédéric Joliot, Orsay, France.
Appl Radiat Isot. 2012 Mar;70(3):489-97. doi: 10.1016/j.apradiso.2011.10.015. Epub 2011 Nov 11.
Imaging of TSPO 18 kDa with PET is more and more considered as a relevant biomarker of inflammation in numerous diseases. Development of new radiotracers for TSPO 18 kDa has seen acceleration in the last years and the challenge today is to make available large amounts of such a radiotracer in compliance with GMP standards for application in humans. We present in this technical note automated productions of [(18)F]DPA-714, [(18)F]PBR111 and [(18)F]FEDAA1106, three promising radiotracers for TSPO 18 kDa imaging, using a TRACERlab FX-FN synthesizer. This note also includes the quality control data of the validation batches for the manufacturing qualification of clinical production of [(18)F]DPA-714.
利用正电子发射断层扫描(PET)对18 kDa的转运蛋白18 kDa(TSPO)进行成像,越来越被视为多种疾病中炎症的相关生物标志物。近年来,用于18 kDa TSPO的新型放射性示踪剂的研发进程加快,而目前面临的挑战是按照药品生产质量管理规范(GMP)标准提供大量此类放射性示踪剂,以供人体应用。在本技术说明中,我们介绍了使用TRACERlab FX-FN合成仪对[(18)F]DPA-714、[(18)F]PBR111和[(18)F]FEDAA1106这三种用于18 kDa TSPO成像的有前景的放射性示踪剂进行自动化生产的情况。本说明还包括[(18)F]DPA-714临床生产制造资质验证批次的质量控制数据。