Fully automated radiosynthesis of [68Ga]Ga-FAPI-46 with cyclotron produced gallium

EJNMMI Radiopharmacy and Chemistry

Research Article

Jonathan A. Kropski¹  Carina Sollert²  Fei Liu³  Yiu-Yin Cheung³  Todd E. Peterson⁴  Adam J. Rosenberg⁴ 

[1] Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, 37232, Nashville, TN, USA;GE HealthCare, Uppsala, Sweden;Vanderbilt University Institute of Imaging Science, Vanderbilt University Medical Center, 37232, Nashville, TN, USA;Vanderbilt University Institute of Imaging Science, Vanderbilt University Medical Center, 37232, Nashville, TN, USA;Department of Radiology and Radiological Sciences, Vanderbilt University Medical Center, 37232, Nashville, TN, USA;Vanderbilt Ingram Cancer Center, 37232, Nashville, TN, USA;

关键词: FAPI;    Radiolabeling;    Gallium-68;    Cyclotron;    Automation;    GMP compliance;    Radiochemistry;    Radiopharmaceuticals;   

DOI  :  10.1186/s41181-023-00216-0

 received in 2023-08-08, accepted in 2023-10-04,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundRadiopharmaceuticals capable of targeting the fibroblast activation protein have become widely utilized in the research realm as well as show great promise to be commercialized; with [68Ga]Ga-FAPI-46 being one of the most widely utilized. Until now the synthesis has relied on generator-produced gallium-68. Here we present a developed method to utilize liquid-target cyclotron-produced gallium-68 to prepare [68Ga]Ga-FAPI-46.ResultsA fully-automated manufacturing process for [68Ga]Ga-FAPI-46 was developed starting with the 68Zn[p,n]68Ga cyclotron bombardment to provide [68Ga]GaCl3, automated purification of the [68Ga]GaCl3, chelation with the precursor, and final formulation/purification. The activity levels produced were sufficient for multiple clinical research doses, and the final product met all release criteria. Furthermore, the process consistently provides < 2% of Ga-66 and Ga-67 at the 4-h expiry, meeting the Ph. Eur. standards.ConclusionsThe automated radiosynthesis on the GE FASTlab 2 module purifies the cyclotron output into [68Ga]GaCl3, performs the labeling, formulates the product, and sterilizes the product while transferring to the final vial. Production of > 40 mCi (> 1480 MBq) of [68Ga]Ga-FAPI-46 in excellent radiochemical yield was achieved with all batches meeting release criteria.

【 授权许可】

CC BY   
© Springer Nature Switzerland AG 2023

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