GMP production of 68Ga-labelled DOTA-NOC on IBA Synthera

68 Ga labelled peptides are increasingly being used clinically due to widespread availability of 68 Ge/ 68 Ga generators and their recognised importance in the diagnosis of neuroendocrine tumours. A simple and reproducible GMP-compliant process for labelling peptides with generator-produced 68 Ga is crucial to meet current pharmaceutical requirements. Here, we describe the development of a cassette-based 68 Ga-radiolabelling process using an automated commercial synthesizer coupled with a standard 68 Ge/ 68 Ga generator. The radiolabeled somatostatin analogue [ 68 Ga]DOTA-NOC was successfully synthesized in about 30 min with 80.3 ± 3.20 % of decay corrected radiochemical yield. The process is easily adaptable to the labelling of other peptides such as DOTA-TOC or DOTA-TATE for diagnosis or therapy.