Installation and Optimization of ⁶⁸Ga Synthesis Module for Clinical Use: An Institutional Experience

With advent of gallium-labeling somatostatin analogs and its evaluation under positron emission tomography-computed tomography, there has been a tremendous surge in its application. Gallium 68 can be made available either from onsite cyclotron production or in the form of ready-to-use ⁶⁸Ge/⁶⁸Ga generators. Wherein setting up and running of cyclotron amounts to huge investment and dedicated team, the ⁶⁸Ge/⁶⁸Ga generator has proved to be a better option and viable project. Moreover, due to long half-life of ⁶⁸Ge, i.e. 271 days, it enables the usage of generator for several months. The preparation of gallium-labeled peptides is much simpler in comparison to 18F radiochemistry, but the radiation exposure has always been an area of concern owing to high-energy annihilation photon of 511 keV.

In this study, we share our experience of self-installation of ⁶⁸Ge/⁶⁸Ga generator during lockdown and the various steps involved in installation of fully automated peptide-labeling system in customized mini hot cell module, synthesis steps, and quality control steps of gallium-based radiopharmaceutical.

The installation was successfully completed with online assistance during the pandemic situation. The average elution yield met company specification (>80%), and ⁶⁸Ga-labeled peptides were prepared with high radiochemical purity (>95%). The overall exposure in single batch of production and quality control never exceeded 3 μSv as shielding was well-taken care of with customized mini hot cell.

With the described experience and validation process, one can easily think of making an installation at his/her center and cater to the needs of society with a new radiopharmaceutical.