cGMP-compliant high-yield automated production of [18F]AlF-FAPI-74: optimization of quality control and evaluation of molar dose impact
A robust, fully automated, and GMP-compliant production process for [<sup>18</sup>F]AlF-FAPI-74 is reported with high yield, purity, and stability, suitable for centralized production and distribution. The improved radio-HPLC method enhances quality control precision by accurately quantifying radiochemical and chemical purity. In vivo experiments confirmed fast tumor uptake of [<sup>18</sup>F]AlF-FAPI-74. While a clear mass effect on tumor-to-background ratios was observed in preclinical studies, high apparent molar activity resulted in excellent contrast in a clinical setting.
Authors
- Romaric Gérardy (ORCID: https://orcid.org/0000-0002-8626-2719)
- John Maes (ORCID: https://orcid.org/0000-0003-3971-4820)
- Karolien Goffin (ORCID: https://orcid.org/0000-0002-7453-0229)
- Corentin Warnier (ORCID: https://orcid.org/0000-0001-6221-4547)
- Thibault Gendron (ORCID: https://orcid.org/0000-0002-2162-3704)
- Christophe M. Deroose (ORCID: https://orcid.org/0000-0002-6080-1577)
- Frederik Cleeren (ORCID: https://orcid.org/0000-0002-3692-1608)
- Laura Trump
- Tjibbe de Groot
- Kim Serdons
- Sofie Celen (ORCID: https://orcid.org/0000-0002-6742-7469)
- Koen Van Laere (ORCID: https://orcid.org/0000-0001-5200-7245)
- Janke Kleynhans (ORCID: https://orcid.org/0000-0001-9393-8855)
- William W. Storms
Institutions
- University of Liège (BE)
- Brussels School of International Studies (BE)
- KU Leuven (BE)
Publication Details
- Journal
- EJNMMI Radiopharmacy and Chemistry
- Published
- 2025-12-14
- DOI
- https://doi.org/10.1186/s41181-025-00411-1
- Primary Topic
- Peptidase Inhibition and Analysis
- Type
- article
- Field-Weighted Citation Impact
- 0.00