Fully-automated production of [⁶⁸Ga]Ga-FAPI-46 for clinical application

Area of Science:

• Radiochemistry
• Nuclear Medicine
• Pharmaceutical Sciences

Background:

• [68Ga]Ga-FAPI-46 is a positron emission tomography tracer for fibroblast activation protein (FAP) detection.
• Current synthesis methods for [68Ga]Ga-FAPI-46 are manual, limiting clinical accessibility.
• Automating the synthesis is crucial for widespread clinical use.

Purpose of the Study:

• To evaluate the automated synthesis of [68Ga]Ga-FAPI-46.
• To assess the feasibility of using two commercial synthesis modules for automated production.
• To ensure the tracer's availability for clinical applications.

Main Methods:

• Automated synthesis of [68Ga]Ga-FAPI-46 on Modular Lab PharmTracer (MLPT) and Modular Lab eazy (ML eazy).
• Optimization of precursor amounts (10-50 μg) and use of customized synthesis templates and cassettes.
• Quality control testing including sterility, stability, and radiochemical purity.

Main Results:

• Optimal synthesis yielded [68Ga]Ga-FAPI-46 with 50 μg of FAPI-46 precursor for multi-dose application.
• Automated synthesis was successfully performed on both MLPT and ML eazy modules.
• All quality control parameters met European Pharmacopoeia standards.

Conclusions:

• Fully automated synthesis of [68Ga]Ga-FAPI-46 is feasible on MLPT and ML eazy.
• The automated process makes [68Ga]Ga-FAPI-46 readily available for multi-dose clinical use.
• This automation facilitates broader clinical application of FAP-targeted PET imaging.