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Journal of Nuclear Medicine

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Meeting ReportRadiopharmaceutical Chemistry: New Radiopharmaceuticals-Broader/General Applications

Modification of fluorine-18 synthesis modules to enable cGMP synthesis of radiopharmaceuticals using multiple radiochemical strategies

Peter Scott, Xia Shao, Raphael Hoareau and Brian Hockley
Journal of Nuclear Medicine May 2010, 51 (supplement 2) 1453;
Peter Scott
1Radiology, University of Michigan, Ann Arbor, MI
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Xia Shao
1Radiology, University of Michigan, Ann Arbor, MI
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Raphael Hoareau
1Radiology, University of Michigan, Ann Arbor, MI
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Brian Hockley
1Radiology, University of Michigan, Ann Arbor, MI
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Abstract

1453

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

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Journal of Nuclear Medicine
Vol. 51, Issue supplement 2
May 2010
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Modification of fluorine-18 synthesis modules to enable cGMP synthesis of radiopharmaceuticals using multiple radiochemical strategies
Peter Scott, Xia Shao, Raphael Hoareau, Brian Hockley
Journal of Nuclear Medicine May 2010, 51 (supplement 2) 1453;

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Modification of fluorine-18 synthesis modules to enable cGMP synthesis of radiopharmaceuticals using multiple radiochemical strategies
Peter Scott, Xia Shao, Raphael Hoareau, Brian Hockley
Journal of Nuclear Medicine May 2010, 51 (supplement 2) 1453;
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