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

.sup.68Ga labelled peptides are increasingly being used clinically due to widespread availability of .sup.68Ge/.sup.68Ga generators and their recognised importance in the diagnosis of neuroendocrine tumours. A simple and reproducible GMP-compliant process for labelling peptides with generator-produced .sup.68Ga is crucial to meet current pharmaceutical requirements. Here, we describe the development of a cassette-based .sup.68Ga-radiolabelling process using an automated commercial synthesizer coupled with a standard .sup.68Ge/.sup.68Ga generator. The radiolabeled somatostatin analogue [.sup.68Ga]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.