68Ga-Autoclabeling of DOTA-TATE and DOTA-NOC

IntroductionA new method combining 68Ga-labeling and steam sterilization, here called autoclabeling, has been evaluated for two somatostatin receptor binding tracers used for positron emission tomography (PET) imaging of neuroendocrine tumors; DOTA-TATE and -NOC.MethodsThe two peptides DOTA-TATE and -NOC were labeled with 68Ga by heating for 15 min at 121 °C in the presence of acetate buffer at pH 4.3. The product solutions were tested for sterility, presence of endotoxins, degradation of peptide and osmolality.ResultsComplete incorporation of 68Ga was obtained after the autoclabeling reaction and no degradation of the peptides was observed. Sterility was verified and the presence of endotoxins was well within Ph. Eur limits (175IU/maximum injected volume).ConclusionsThe autoclabeling method provides a convenient procedure for 68Ga-labeling by combining the labeling reaction and steam sterilization into one single step.

HighLights
► We present a one-pot, one-step reaction and sterilization procedure.
► The final product is isotonic and suitable for intravenous injection.
► Total production time, handling and personell dose is minimized.
► Validated and in accordance with Ph. Eur.