RT Journal Article
SR Electronic
T1 Modification of fluorine-18 synthesis modules to enable cGMP synthesis of radiopharmaceuticals using multiple radiochemical strategies
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 1453
OP 1453
VO 51
IS supplement 2
A1 Scott, Peter
A1 Shao, Xia
A1 Hoareau, Raphael
A1 Hockley, Brian
YR 2010
UL http://jnm.snmjournals.org/content/51/supplement_2/1453.abstract
AB 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 acknowledgedSynthesis Data