13-18 May 2018
Casino Conference Centre
Europe/Prague timezone

Fully automated GMP [68Ga]GaDOTA-TOC production using TRACERlab® MX module

17 May 2018, 17:30
1h 30m
Gallery (Casino Conference Centre)


Casino Conference Centre

Reitenbergerova 4/95, Mariánské Lázně, Czech Republic
Poster Radiopharmaceutical Chemistry, Labelled Compounds Poster RPH


Prof. Pavol Rajec (BIONT a.s.)


The application of 68Ga –labeled peptide for tumor diagnosis is growing very fast in the recent years. One of the traced peptide for tumor diagnosis in nuclear medicine is [68Ga]GaDOTA-TOC. The aim of the work was GMP preparation of [68Ga]GaDOTA-TOC for application in nuclear medicine for a routine diagnosis using automated production with TRACERlab® MX module and quality control according to the standards of European Pharmacopoeia. 68Ga for peptide tracing was obtained from 68Ge/68Ga generator iThemba Labs with initial activity 1850 MBq. 5 mL of 0.6 M HCl elution solution from the generator was collected to the vial and for synthesis of 68Ga labeled peptide a commercial cassette and chemical kit from ABX was used. 68Ga was collected on PS-H+ cartridge, washed and transferred to reaction vials with 5 M NaCl in which 50 µg of DOTA-TOC dissolved in 1.5 M HEPES was prepared. The temperature in the reactor vessels was kept 6 min at 125oC. The solution with reaction mixture was past trough a pre-conditioned Light C18 column and washed with water. Labeled [68Ga]GaDOTA-TOC was eluted with a mixture 1:1 ethanol/water to the vial and diluted with PBS buffer. Prepared solution was transferred to a dispense chamber trough a sterile filter. Decay correcting yield was about 89%. Parameters for quality control (QC) were appearance, pH, radionuclide purity, radionuclide identity, radiochemical purity, HEPES concentration, microbiological quality, bacterial endotoxins and ethanol concentration. All validation parameters of [68Ga]GaDOTA-TOC QC analysis prepared were fulfilled. Radiochemical purity was better than 98.8%. 68Ga impurity in colloidal form was less than 1% and free 68Ga3+ was less than 0.1%. Prepared [68Ga]GaDOTA-TOC was used in patients with neuroendocrine tumours (NET) with better sensitivity and spatial resolution in comparison to standard imaging procedure.

Primary author

Prof. Pavol Rajec (BIONT a.s.)


Ms Darina Tóthová (BIONT a.s.) Ms Iveta Mitová (BIONT a.s.) Mr Lukáš Kňaz (BIONT a.s.) Mr Lukáš Rada (BIONT a.s.) Mr Miloslava Štefečka (BIONT a.s.) Dr Pavol Kruk (BIONT a..s.) Dr Pavol Povinec (BIONT a.s.) Mr Vojtech Csiba (BIONT a.s.) Mr Zoltán Krascsenits (BIONT a.s.)

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