*3.2. Automation*

With the vast development of <sup>89</sup>Zr radiolabeled antibodies for diagnostic application using PET imaging and increasing demand for their clinical use, there is a need for cGMP grade <sup>89</sup>Zr. In this study, we have adopted a commercially available cGMP-compliant TRASIS miniAiO to achieve efficient and reproducible batches of <sup>89</sup>Zr. This automated module was used for the target dissolution and separation of <sup>89</sup>Zr from the yttrium. In our method, the separation time including dissolution of the target was completed within 1 h. In addition, automated data acquisition was employed, allowing for full GMP-compliant documentation of the process. Furthermore, hydroxamate resin cartridge preconditioning and sterile-filter integrity testing were programmed in the same sequence file. The <sup>89</sup>Zr was eluted with a very small volume of oxalic acid (1.5 mL) directly over the sterile filter into the final vial. The automation of <sup>89</sup>Zr resulted in a significant reduction in the radiation dose and increased the GMP compliance.

Wooten et al. [14]. described an in-house automation system for <sup>89</sup>Zr processing constructed from extruded Al modular framing attached to walls made of ultra-high molecular weight polyethylene with components mounted on the plastic walls and a computer-controlled separation. This in-house automation method suffered from rather low and inconsistent recoveries (44–97%; average 74% ± 16%), while this work had a consistent recovery of 88.2–98.1% (average 93.6% ± 5%). Unlike the in-house module, the use of the GMP-certified AllinOne ASU produced under ISO 9001 offers an easier pathway to obtaining <sup>89</sup>Zr that meets cGMP needs for clinical studies.
