Abstract
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Objectives The field of radiochemistry is moving towards exclusive use of automated synthesis modules for production of clinical radiopharmaceutical doses. Such a move comes with many advantages, but also presents radiochemists with the challenge of re-configuring synthesis modules for production of radiopharmaceuticals that require non-conventional radiochemistry whilst maintaining full automation and compliance with cGMP regulations. Herein we present simple, fully automated methods for producing [18F]FLT, [18F]MPPF, [18F]sodium fluoride, [18F]fluorocholine, [18F]SFB and [18F]radiolabeled triazoles using a modified General Electric (GE) Tracerlab FXFN synthesis module.
Methods Fluoride-18 was produced via the 18O(p,n)18F nuclear reaction using a GE PETTrace cyclotron equipped with a high yield fluorine-18 target. Fully automated production of [18F]labeled radiopharmaceuticals was carried out using a Tracerlab FXFN synthesis module. Quality control of radiopharmaceuticals was carried out in accordance with the U.S. Pharmacopeia (Chapter 823).
Results Simple modifications to a GE Tracerlab FX-FN will be disclosed that enable production of radiopharmaceuticals using multiple different radiochemical approaches. To demonstrate proof-of-concept, fully automated GMP compliant synthesis methods for production of [18F]FLT, [18F]MPPF, [18F]sodium fluoride, [18F]fluorocholine, [18F]SFB and [18F]radiolabeled triazoles using the modified synthesis module will be reported, along with complete quality control data.
Conclusions The Tracerlab FXFN has proven a versatile synthesis module in our hands. The results disclosed herein demonstrate that through simple modifications, GMP production of radiopharmaceuticals via multiple state-of-the-art radiochemical techniques is enabled.
Research Support Support of this work by the Department of Energy, Office of Science is gratefully acknowledged
Synthesis Data