Radiopharmaceuticals · PET Tracers
PET Tracer Manufacturing Under GMP
Expertise you can rely on — from cyclotron production to aseptic dispensing.
Positron Emission Tomography (PET) is a cornerstone of modern diagnostic imaging, enabling non-invasive, real-time visualization of physiological processes. The tracers used in PET — typically radiolabeled small molecules — must be manufactured and controlled with speed, sterility, and full regulatory compliance.
With a strong background in GMP auditing, compliance consulting, and radiopharmaceutical QA, I bring deep expertise in the manufacturing, quality control, and release of PET tracers used in clinical research and diagnostic imaging — including products such as Amyvid®, custom amyloid ligands, and fluorine-18 or carbon-11-based tracers.
Complex products, streamlined oversight
PET tracer manufacturing typically follows a 3-step process:
The core of my expertise lies in auditing and validating GMP step 2: automated synthesis in hot cells, use of validated kits, traceability and aseptic dispensing, and sterility assurance under time pressure — including provisional QP release procedures before full sterility data is available. This release-before-sterility model is fully accepted by regulators under 21 CFR Part 212 (US) and Eudralex Volume 4, Annex 3 (EU).