Manual vs. automated 68Ga ‐radiolabeling ‐ a comparison of optimized processes

A critical factor for clinical practice is the production of68Ga ‐radiopharmaceuticals manufactured manually or through an automated procedure.68Ga ‐radiopharmaceuticals are often prepared manually, although this method can lead to an increased operator´s radiation dose and potential variability within production.The present work compares68Ga ‐radiolabeling (PSMA‐11; DOTA‐TOC) utilizing a cassette module (GAIA; Elysia‐Raytest; Germany) with a manual setup for routine clinical production with regard to process reliability and reproducibility.A total 837 routine production batches from 2015 ‐2017 were retrospectively analysed. PSMA‐11 and DOTA‐TOC were radiolabeled with gallium‐68 manually as well as on a cassette module system. Quality control, as well as statistical analysis were performed.There were significant differences between these production processes in terms of radioactivity yield (AY) and radiochemical yield (RCY), as well as process duration. For, e.g., [68Ga]Ga ‐PSMA‐11 the average difference between manual and automated process is 6.7 min (process duration), 17.5 % (AY) and 10.2 % (RCY).The automated process is superior to manual method in all categories and presents significant improvements of68Ga ‐radiolabeling for routine clinical production in terms of reliability and reproducibility with the additional advantage of reduced operator's radiation exposure.
Source: Journal of Labelled Compounds and Radiopharmaceuticals - Category: Biochemistry Authors: Tags: RESEARCH ARTICLE Source Type: research