Production and Semi-Automated Processing of ⁸⁹Zr Using a Commercially Available TRASIS MiniAiO Module

The increased interest in ⁸⁹Zr-labelled immunoPET imaging probes for use in preclinical and clinical studies has led to a rising demand for the isotope. The highly penetrating 511 and 909 keV photons emitted by ⁸⁹Zr deliver an undesirably high radiation dose, which makes it difficult to produce large amounts manually. Additionally, there is a growing demand for Good Manufacturing Practices (GMP)-grade radionuclides for clinical applications. In this study, we have adopted the commercially available TRASIS mini AllinOne (miniAiO) automated synthesis unit to achieve efficient and reproducible batches of ⁸⁹Zr. This automated module is used for the target dissolution and separation of ⁸⁹Zr from the yttrium target material. The ⁸⁹Zr is eluted with a very small volume of oxalic acid (1.5 mL) directly over the sterile filter into the final vial. Using this sophisticated automated purification method, we obtained satisfactory amount of ⁸⁹Zr in high radionuclidic and radiochemical purities in excess of 99.99%. The specific activity of three production batches were calculated and was found to be in the range of 1351-2323 MBq/µmol. ICP-MS analysis of final solutions showed impurity levels always below 1 ppm.