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首页> 外文期刊>EJNMMI Radiopharmacy and Chemistry >Futureproofing [ 18 F]Fludeoxyglucose manufacture at an Academic Medical Center
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Futureproofing [ 18 F]Fludeoxyglucose manufacture at an Academic Medical Center

机译：面向未来的[18 F]学术医学中心生产氟氧葡萄糖

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Abstract BackgroundWe recently upgraded our [18F]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.ResultsFollowing installation of Nb targets for production of fluorine-18, a 55?μA beam for 22?min generated 1330?±?153?mCi of [18F]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 ( n =?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.ConclusionsThe 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.
机译：摘要背景我们最近升级了[18F]脱氧葡萄糖（FDG）的生产能力，以期对我们的FDG临床供应进行前瞻性验证，扩大每天可生产的FDG的批次数量，并提高我们核医学诊所的患者通量。在本文中，我们从实践和监管角度报告了将合成模块升级到GE FASTLab 2平台（第1阶段）和回旋加速器更新（第2阶段）的情况。我们总结了在FASTLab 2模块上使用高产量自屏蔽铌（Nb）氟18靶材制造FDG的经验。结果安装了生产氟18的Nb靶材后，产生了55？μA的光束，持续了22？min [18F]氟化物为1330±±153μmCi。将这些回旋加速器束参数与FASTLab 2结合使用时，FDG的活度产量（AY）在EOS时为957？±？102？mCi，相当于72％的未校正AY（n =？235）。在合成模块和回旋加速器升级之后，我们的工作流程，库存管理和法规遵从性得到了极大简化，并且在核医学诊所，FDG PET的患者等待时间缩短了一半。结论FASTlab 2和自屏蔽Nb氟- 18个目标提高了我们的FDG产量，并使放射示踪剂可靠且可重复地制造出来以用于临床。

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