Objectives [ 68 Ga]Ga-HBED-11-PSMA (PSMA) and [ 68 Ga]Ga- DOTA-tate (DOTAtate) are two well established PET tracers for diagnostic and staging of prostate cancer (PCa) and neuroendocrine tumours (NET) respectively. In our department we have used a Trasis AllinOne (AiO) synthesiser since late 2014 to routinely produce [ 68 Ga]Ga-DOTA-tate, [ 18 F]fluorocholine ([ 18 F]FCH) and [ 68 Ga]Ga-HBED- 11-PSMA. [ 18 F]FCH was initially produced for a comparative clinical trial to demonstrate the superiority of [ 68 Ga]Ga-HBED-11-PSMA compared to [ 18 F]FCH in diagnostic and staging of PCa[1]. In order to produce this range of radiolabelled compounds, a versatile, reliable, cassette based synthesizer was required. Results • [ 18 F]FCH was produced in 21 % radioactivity yield (average from 41 production runs) within 45 min (time between [ 18 F]F - transfer to synthesizer and product activity measurement. For [ 18 F]FCH production runs, radioactivity yields were calculated from the delivered starting activity of [ 18 F]F - . • Average radioactivity yield, radiochemical yield (RCY), and labelling efficiency for [ 68 Ga]Ga- HBED-11-PSMA and [ 68 Ga]Ga-DOTA-tate are displayed in graphs 1 and 2 on the right for different prepurification methods used. The activity yields given are an estimate based on the activity eluted rinsing the generator(s) at the beginning of a week. For gallium-68 labelling reactions, labelling efficiencies were calculated based on the amount of product as a percentage of the total amount of radioactivity recovered at the end of synthesis (waste vial and sterile filter). • Table 1 lists synthesis times and number of patient runs for [ 68 Ga]Ga-HBED-11-PSMA and [ 68 Ga]Ga-DOTA-tate. Synthesis times are calculated from the time of generator elution to the time of product activity measurement. Methods [ 18 F]FCH was produced utilising 18 actuators in the top row of the AiO synthesiser. The 68 Ga-labelled compounds were synthesised using the first six actuators in each row. Both 68 Ga-complexed compounds were initially produced with a method using anionic prepurification of the 68 Ge/ 68 Ga-generator eluate. Early in 2016 the routine synthesis process was changed to a method without prepurification to shorten synthesis time. Since mid-2016 a process using cationic prepurification has been implemented. Only taking a few minutes longer than the process without prepurification, this method allows for efficient prepurification of the eluate as well as the elution of multiple generators in parallel. All methods have product purification using a HLB cartridge in common. The product is then sterile filtered into the product vial. Labelling efficiencies and radioactivity yields for different products and generator eluate prepurification methods used are tabulated below (cf results). • Typical QC results for [ 68 Ga]Ga-HBED-11-PSMA and [ 68 Ga]Ga-DOTA-tate, formulated as an injectable sterile saline solution containing ~ 5 % ethanol were as follows: pH 5.5 DOTAtate RCP by TLC > 95 % DOTAtate RCP by HPLC > 96 % PSMA RCP by HPLC > 97 % Conclusion Over a period of more than two years, the AiO synthesizer has been used for over 530 [ 68 Ga]Ga- HBED-11-PSMA, over 140 [ 68 Ga]Ga-DOTA-tate, and over 45 [ 18 F]FCH synthesis. Product quality and yield have been reproducible and the synthesiser has proven to be very reliable for automated routine production in a clinical environment. References [1] J. Morigi et al., The Journal of Nuclear Medicine 2015, Vol. 56 No. 8, 1185-1190 Use of a Trasis AllinOne Synthesizer for routine clinical production of [ 68 Ga]Ga-HBED-11-PSMA and [ 68 Ga]Ga-DOTA-tate and [ 18 F]fluorocholine D. Stark 1 and T. Vergote 2 1 St. Vincent's Public Hospital Sydney Diagnostics Services Department - Nuclear Medicine and PET, Darlinghurst, Australia; 2 Trasis SA, Ans, Belgium Trasis Supervision user interface. Schematics of synthesiser layout visible on right. Layout for process with cationic prepurification and use of two generators eluted in parallel. Graph 1 (left): Labelling efficiency. Graph 2 (right): Radioactivity yield and Radiochemical Yield (RCY). Table 1: Synthesis times and patient run numbers for 68 Ga- labelled compounds. Product Method n (2015 / 2106) Synthesis Time [ 68 Ga]Ga-DOTA-tate anionic 51 / 15 32 min without 0 / 32 20 min [ 68 Ga]Ga-HBED-11-PSMA anionic 262 / 76 32 min without 0 / 174 20 min cationic 0 / 16 23 min 40 54 35 53 73 59 51 56 69 48 73 89 75 70 0 10 20 30 40 50 60 70 80 90 100 anionic without cationic anionic Radioactivity Yiled and Radiochemical Yield (RCY) DOTA (Radioactivity Yield) PSMA (Radioactivity Yield) DOTA (RCY) PSMA (RCY) 2016 2015 % 72 85 71 95 99 91 90 0 10 20 30 40 50 60 70 80 90 100 anionic without cationic anionic Labelling Efficiency DOTA PSMA 2015 2016 %