Robust radiopharmaceutical production, proven quality and high activity – how to have it all (#113)
A range of theranostic radiopharmaceuticals are routinely manufactured on site at RBWH, for both imaging and radionuclide therapy. These include 68GaDOTA TATE, 68GaPSMA HBED-CC, 68GaPentixafor, 177LuDOTA TATE and 177LuPSMA-617. Processes have been designed to maximise commonalities across all tracers, to support process translation for other compounds. Where required, manufacture has been optimised to achieve stability at higher activities. The kit-based approach coupled with an automated production process improves reliability and reproducibility across a number of production operators and also limits radiation exposure. Quality control (QC) tests align closely to monograph guidelines for each compound. The analytical instrumentation is common across a range of compounds so operators are trained to be competent with specific tests. This presentation will describe the evolution of our production and QC protocols, and will detail optimisation undertaken to meet increasing clinical demand.