CGMP-compliant high-yield automated production of [¹⁸F]AlF-FAPI-74: optimization of quality control and evaluation of molar dose impact.

ABSTRACT:

Background

Fibroblast activation protein inhibitor (FAPI)-based positron emission tomography (PET) radiopharmaceuticals have shown promise for imaging cancer-associated fibroblasts (CAFs), a key component of the tumor microenvironment. FAPI radiopharmaceuticals offer high tumor-to-background contrast and are not influenced by hyperglycemia. Among these, [¹⁸F]AlF-FAPI-74, labeled using the Al¹⁸F-method, offers logistical advantages over ⁶⁸Ga-labeled radiopharmaceuticals, including a longer physical half-life and suitability for large-scale, centralized production. This study reports a fully automated, efficient, and GMP-compliant synthesis of [¹⁸F]AlF-FAPI-74 using the Trasis AllInOne^® platform, alongside a refined isocratic rad

SUBMITTER: Storms W 

PROVIDER: S-EPMC12819903 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature