83% reduction in SOPs for PET release testing with Tracer-QC

21 March 2023

Reducing a highly-skilled time and labour-intensive process to just 5 mouse clicks

Tracer-QC is revolutionising Quality Control testing of PET radiopharmaceuticals by automating the process. It is reducing a highly-skilled and intense process to just 5 clicks of a mouse by combining a plate reader and pipetting robot with consumables into a single instrument. Since the successful validation of Tracer-QC to FDA requirements at the University of California and installation at a commercial PET production site, it has been qualified for the release testing of PET tracers and demonstrably reduced the number of SOPs by 83%.

By comparison to performing traditional QC on PET radiotracers where each test has its own SOP, Tracer-QC consolidates all applicable tests into a single process. This minimises the number of SOPs required along with the necessary training and operator input, making it easier to keep PET production facilities up to date with the latest GMP.

PET radiotracer production is a highly automated process, but release testing still relies on manual methodologies that are time- and labour-intensive, creating a bottleneck in the supply of short-lived radiotracers. This bottleneck is what Tracer-QC has been developed to eliminate by allowing PET radiotracers manufactured on-site to be quickly released.

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