Li Shihong, Schmitz Alexander, Lee Hsiaoju, Mach Robert H
Department of Radiology, University of Pennsylvania, Philadelphia, PA USA.
EJNMMI Radiopharm Chem. 2017;1(1):15. doi: 10.1186/s41181-016-0018-0. Epub 2016 Oct 10.
Fast implementation of positron emission tomography (PET) into clinical and preclinical studies highly demands automated synthesis for the preparation of PET radiopharmaceuticals in a safe and reproducible manner. The aim of this study was to develop automated synthesis methods for these six F-labeled radiopharmaceuticals produced on a routine basis at the University of Pennsylvania using the AllinOne synthesis module.
The development of automated syntheses with varying complexity was accomplished including HPLC purification, SPE procedures and final formulation with sterile filtration. The six radiopharmaceuticals were obtained in high yield and high specific activity with full automation on the AllinOne synthesis module under current good manufacturing practice (cGMP) guidelines.
The study demonstrates the versatility of this synthesis module for the preparation of a wide variety of F-labeled radiopharmaceuticals for PET imaging studies.
在临床和临床前研究中快速应用正电子发射断层扫描(PET)技术,迫切需要以安全且可重复的方式实现PET放射性药物制备的自动化合成。本研究的目的是使用AllinOne合成模块开发用于宾夕法尼亚大学常规生产的这六种F标记放射性药物的自动化合成方法。
完成了具有不同复杂程度的自动化合成开发,包括高效液相色谱(HPLC)纯化、固相萃取(SPE)程序以及通过无菌过滤进行最终制剂配制。在现行药品生产质量管理规范(cGMP)指南下,利用AllinOne合成模块实现了全自动化,以高收率和高比活度获得了这六种放射性药物。
该研究证明了此合成模块在制备用于PET成像研究的多种F标记放射性药物方面的多功能性。