Performance evaluation of Gallium-68 radiopharmaceuticals production using liquid target PETtrace 800 cyclotron.

Due to increased demand, cyclotron has an expanding role in producing Gallium-68 (68Ga) radiopharmaceuticals using solid and liquid targets. Though the liquid target produces lower end-of-bombardment activity compared to the solid target, our study presents the performance of 68Ga radiopharmaceuticals production using the liquid target by evaluating the end-of-bombardment activity and the end-of-purification activity of [68Ga]GaCl3. We also present the effect of increasing irradiation time, which significantly improves the end-of-synthesis yield. From the result obtained, the end-of-bombardment activity produced was 4.48 GBq, and the [68Ga]GaCl3 end-of-purification activity produced was 2.51 GBq with below-limit metallic impurities. Increasing the irradiation time showed a significant increase in the end-of-synthesis activity from 1.33 GBq to 1.95 GBq for [68Ga]Ga-PSMA-11 and from 1.13 GBq to 1.74 GBq for [68Ga]Ga-DOTA-TATE. Based on the improvements made, the liquid target production of 68Ga radiopharmaceuticals is feasible and reproducible to accommodate up to 5 patients per production. In addition, this work also discusses the issues encountered, together with the possible corrective and preventative measures.

Cyclotron Production of Gallium-68 Radiopharmaceuticals Using the 68Zn(p,n)68Ga Reaction and Their Regulatory Aspects.

Designing and implementing various radionuclide production methods guarantees a sustainable supply, which is important for medical use. The use of medical cyclotrons for radiometal production can increase the availability of gallium-68 (68Ga) radiopharmaceuticals. Although generators have greatly influenced the demand for 68Ga radiopharmaceuticals, the use of medical cyclotrons is currently being explored. The resulting 68Ga production is several times higher than obtained from a generator. Moreover, the use of solid targets yields end of purification and end of synthesis (EOS) of up to 194 GBq and 72 GBq, respectively. Furthermore, experiments employing liquid targets have provided promising results, with an EOS of 3 GBq for [68Ga]Ga-PSMA-11. However, some processes can be further optimized, specifically purification, to achieve high 68Ga recovery and apparent molar activity. In the future, 68Ga will probably remain one of the most in-demand radionuclides; however, careful consideration is needed regarding how to reduce the production costs. Thus, this review aimed to discuss the production of 68Ga radiopharmaceuticals using Advanced Cyclotron Systems, Inc. (ACSI, Richmond, BC, Canada) Richmond, Canada and GE Healthcare, Wisconsin, USA cyclotrons, its related factors, and regulatory concerns.