RT Journal Article
SR Electronic
T1 Automated production of [<sup>18</sup>F]F<sup>-</sup> and [<sup>18</sup>F]FDG at the University of Oklahoma Health Sciences Center (OUHSC)
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 1166
OP 1166
VO 54
IS supplement 2
A1 Awasthi, Vibhudutta
A1 Gali, Hariprasad
A1 McFarland, Aaron
A1 Anzellotti, Atilio
YR 2013
UL http://jnm.snmjournals.org/content/54/supplement_2/1166.abstract
AB 1166 Objectives The OUHSC-College of Pharmacy has installed and commissioned the first Biomarker Generator comprising an automated cyclotron-synthesis box-quality control system for on-site manufacture of [18F]F- and [18F]FDG. Performance, reliability and safety of the system for production of 'Dose on demand' was tested over several months. Methods The Biomarker Generator is a 7.5 MeV positive-ion cyclotron coupled with a customized Chemistry Production Module. Automated QC tests were performed on each dose. The HPLC-based analytical methods were validated against USP methods of quality control. The entire hardware was controlled by a National Instruments DAQ using LabView software. A customized and scaled down monitoring system was installed for radiation safety purposes, in view of the self-shielded production of limited quantities of [18F]F- per run. Results After initial installment and optimization, [18F]F- production has been consistent since Mar 2011 with a maximum production of 400 to 450 mCi/day (≈ 1 mCi/3.5 μA.min). The current target window has held up for over 25 weeks against &gt; 400 bombardment cycles. [18F]FDG production has been consistent since Jun 2012 with an average of six doses/day in automated synthesis mode (RCY≈ 50%) . The release criteria included USP-specified limits for pH, residual solvents, kryptofix, radiochemical purity/identity and filter integrity test. When injected in a mouse model of xenograft tumor, the [18F]FDG produced in the Biomarker Generator was found to be bioequivalent to the commercially available [18F]FDG. The entire operation was deemed satisfactory from radiation safety viewpoint. Conclusions Automated and safe production and quality control of '[18F]FDG dose on demand' has been accomplished by the World's first installed Biomarker Generator. The implementation of a GMP quality system is under way towards the ANDA submission and first clinical use of [18F]FDG. Detail production, QC and radiation safety aspects will be presented.