Sowa Alexandra R, Jackson Isaac M, Desmond Timothy J, Alicea Jeremiah, Mufarreh Anthony J, Pham Jonathan M, Stauff Jenelle, Winton Wade P, Fawaz Maria V, Henderson Bradford D, Hockley Brian G, Rogers Virginia E, Koeppe Robert A, Scott Peter J H
1Department of Radiology, University of Michigan, Ann Arbor, MI 48109 USA.
2Department of Medicinal Chemistry, University of Michigan, Ann Arbor, MI 48109 USA.
EJNMMI Radiopharm Chem. 2018 Oct 5;3:12. doi: 10.1186/s41181-018-0048-x. eCollection 2018 Dec.
We recently upgraded our [F]fludeoxyglucose (FDG) production capabilities with the goal of futureproofing our FDG clinical supply, expanding the number of batches of FDG we can manufacture each day, and improving patient throughput in our nuclear medicine clinic. In this paper we report upgrade of the synthesis modules to the GE FASTLab 2 platform (Phase 1) and cyclotron updates (Phase 2) from both practical and regulatory perspectives. We summarize our experience manufacturing FDG on the FASTLab 2 module with a high-yielding self-shielded niobium (Nb) fluorine-18 target.
Following installation of Nb targets for production of fluorine-18, a 55 μA beam for 22 min generated 1330 ± 153 mCi of [F]fluoride. Using these cyclotron beam parameters in combination with the FASTLab 2, activity yields (AY) of FDG were 957 ± 102 mCi at EOS, corresponding to 72% non-corrected AY ( = 235). Our workflow, inventory management and regulatory compliance have been greatly simplified following the synthesis module and cyclotron upgrades, and patient wait times for FDG PET have been cut in half at our nuclear medicine clinic.
The combination of FASTlab 2 and self-shielded Nb fluorine-18 targets have improved our yield of FDG, and enabled reliable and repeatable manufacture of the radiotracer for clinical use.
我们最近升级了氟脱氧葡萄糖（FDG）的生产能力，目的是确保FDG临床供应的可持续性，增加每日可生产的FDG批次数量，并提高我们核医学诊所的患者通量。在本文中，我们从实际和监管角度报告了合成模块升级到GE FASTLab 2平台（第一阶段）以及回旋加速器的更新（第二阶段）。我们总结了在FASTLab 2模块上使用高产自屏蔽铌（Nb）-18氟靶制造FDG的经验。
安装用于生产氟-18的Nb靶后，22分钟的55μA束流产生了1330±153毫居里的[F]氟化物。将这些回旋加速器束流参数与FASTLab 2结合使用，在EOS时FDG的活度产率（AY）为957±102毫居里，对应于72%的未校正AY（=235）。合成模块和回旋加速器升级后，我们的工作流程、库存管理和法规合规性得到了极大简化，我们核医学诊所的FDG PET患者等待时间缩短了一半。
FASTlab 2和自屏蔽Nb氟-18靶的结合提高了我们FDG的产率，并实现了可靠且可重复地制造用于临床的放射性示踪剂。
