Three-step two-pot automated production of NCA [¹⁸F]FDOPA with FlexLab module

Area of Science:

• Radiochemistry
• Nuclear Medicine
• Pharmaceutical Manufacturing

Background:

• No-carrier-added [18F]FDOPA is a crucial radiotracer for Positron Emission Tomography (PET) imaging.
• Automated synthesis methods are essential for consistent and efficient production of radiopharmaceuticals.

Purpose of the Study:

• To implement and evaluate an automated three-step, two-pot synthesis of no-carrier-added [18F]FDOPA.
• To assess the feasibility of using the iPHASE FlexLab module for this synthesis.

Main Methods:

• Automated synthesis of no-carrier-added [18F]FDOPA was performed on the iPHASE FlexLab module.
• A three-step, two-pot reaction sequence was employed.
• Radiochemical yield, purity, and molar activity were analyzed.

Main Results:

• Decay-corrected radiochemical yield ranged from 10% to 14% (n=7).
• Synthesis time was approximately 110 minutes.
• Radiochemical purity exceeded 95% with a molar activity of approximately 431 GBq/μmol.

Conclusions:

• The iPHASE FlexLab module successfully automated the production of no-carrier-added [18F]FDOPA.
• The method demonstrates potential for further process optimization and routine clinical application.
• Built-in activity monitoring facilitates process control and development.