Automated Synthesis of 68Ga-DOTA-TOC with a Cationic Purification System: Evaluation of Methodological and Technical...

Area of Science:

• Nuclear Medicine
• Radiopharmaceutical Chemistry
• Theranostics

Background:

• Gallium-68 (68Ga) is a widely accessible PET isotope, obtainable from generators without requiring a cyclotron.
• Automated synthesis systems are crucial for efficient, reproducible, and safe production of 68Ga-labeled compounds, minimizing radiation exposure.
• Existing automated synthesis systems often need technical adaptations for routine radiopharmaceutical production.

Purpose of the Study:

• To report the production of Gallium-68 DOTA-TOC ([68Ga]Ga-DOTA-TOC) using an automated cassette-based theranostic synthesizer.
• To evaluate the use of a disposable GMP-grade cassette system for cationic purification in the synthesis process.

Main Methods:

• Integration of the automated synthesizer with 68Ge/68Ga generator systems for seamless elution, purification, and radiolabeling.
• Utilized a disposable GMP-grade cassette system for cationic purification.
• Over 100 preparations of [68Ga]Ga-DOTA-TOC were performed over a two-year period (January 2016 - January 2018).

Main Results:

• The automated synthesis process, including elution, purification, and radiolabeling, was completed in approximately 38 minutes.
• Achieved an average synthesis yield of 54.4 ± 2.3%.
• The average radiochemical purity was high, at 96.94 ± 0.74%, with only three failed preparations.

Conclusions:

• The employed methodology and technical solutions successfully produced a high-quality radiopharmaceutical product.
• The results meet the stringent quality standards set by the European Pharmacopoeia.
• This automated approach is suitable for the routine production of [68Ga]Ga-DOTA-TOC.