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Fully-automated production of [68Ga]Ga-PentixaFor on the module Modular Lab-PharmTracer.
EJNMMI Radiopharmacy and Chemistry Pub Date : 2020-02-27 , DOI: 10.1186/s41181-020-0091-2
Sarah Spreckelmeyer 1 , Oliver Schulze 1 , Winfried Brenner 1
Affiliation  

PentixaFor is a promising radiopharmaceutical for positron emission tomography in the detection of different tumor entities and other diseases. Until now, the synthesis of [68Ga]Ga-PentixaFor was reported for the automated synthesis module from Scintomics® only. Our aim was to evaluate the automated synthesis of this radiopharmaceutical on a different module in order to make it available for a broader community. The synthesis of [68Ga]Ga-PentixaFor with different amounts of PentixaFor (50 μg, 30 μg and 20 μg) on the Modular Lab PharmTracer (MLPT) from Eckert & Ziegler with the already established synthesis template for [68Ga]Ga-DOTATOC yielded best results with 50 μg PentixaFor for clinical multi-dose application. All different quality control parameters tested (e.g. sterility, stability and radiochemical purity) were in accordance with the European Pharmacopoeia. [68Ga]Ga-PentixaFor was successfully synthesized fully-automated on the synthesis module Modular Lab PharmTracer and can be used for multi-dose application in clinical settings.

中文翻译:

在模块化Lab-PharmTracer模块上全自动生产[68Ga] Ga-PentixaFor。

PentixaFor是用于正电子发射断层扫描的有前途的放射性药物,可用于检测不同的肿瘤实体和其他疾病。到目前为止,仅从Scintomics®报道了自动合成模块的[68Ga] Ga-PentixaFor的合成。我们的目的是评估该放射性药物在不同模块上的自动化合成,以使其可用于更广泛的社区。在Eckert&Ziegler的Modular Lab PharmTracer(MLPT)上使用已建立的[68Ga] Ga-DOTATOC合成模板,用不同量的PentixaFor(50μg,30μg和20μg)合成[68Ga] Ga-PentixaFor 50μgPentixaFor可用于临床多剂量应用,效果最佳。测试了所有不同的质量控制参数(例如无菌,稳定性和放射化学纯度)符合欧洲药典。在合成模块Modular Lab PharmTracer上成功成功地全自动合成了[68Ga] Ga-PentixaFor,可在临床环境中用于多剂量应用。
更新日期:2020-02-27
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