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Fully Automated GMP-Compliant Synthesis of [18F]FE-PE2I
Klas Bratteby1,2,3, Charlotte Lund Denholt2, Szabolcs Lehel2
1Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100 Copenhagen, Denmark.
Pharmaceuticals (Basel, Switzerland)
|July 2, 2021
Summary
This study optimized the automated synthesis of [18F]FE-PE2I, a key radiotracer for Parkinson's disease diagnosis. High yields and an extended shelf life were achieved, meeting clinical demand for this vital diagnostic agent.
Area of Science:
- Nuclear Medicine
- Radiochemistry
- Neuroimaging
Background:
- Parkinson's disease diagnosis relies heavily on imaging dopamine transporter density.
- Fluorine-18 labeled tracers like [18F]FE-PE2I are crucial for SPECT imaging.
- Challenges exist in the efficient synthesis of [18F]FE-PE2I.
Purpose of the Study:
- To develop a high-yielding, automated, Good Manufacturing Practice (GMP)-compliant synthesis of [18F]FE-PE2I.
- To optimize the formulation and assess the shelf life of the synthesized [18F]FE-PE2I.
- To ensure the radiopharmaceutical meets clinical demand for Parkinson's disease diagnosis.
Main Methods:
- Analysis of factors influencing radiochemical yield for [18F]FE-PE2I synthesis.
- Implementation of a fully automated synthesis on a Synthera®+ platform.
- Optimization of radiopharmaceutical formulation and stability studies.
Main Results:
- Achieved high radiochemical yields (RCYs) up to 62% for [18F]FE-PE2I.
- Successfully isolated 25 GBq of the formulated radiopharmaceutical.
- Optimized formulation resulted in a shelf life of 6 hours.
Conclusions:
- A robust and automated GMP-compliant synthesis for [18F]FE-PE2I has been successfully implemented.
- The optimized process ensures sufficient production and stability to meet clinical needs for Parkinson's disease imaging.
- This advancement facilitates the wider use of [18F]FE-PE2I in diagnosing Parkinson's disease.
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