June 7-11, 2014
At this year’s SNM, our R&D team was proud to present four exciting new features. Two of the features are related to improving the cycle time and scalability of [18F]FDG on the BG system. The other two features add automatic synthesis and quality control testing of radio tracers that can be used in the diagnosis of bone cancer ([18F]NaF) and tumor hypoxia ([18F]FMISO).
30 Minute Cycle Time - The purpose of this project was to implement features to lower dose-to-dose cycle time below 30 minutes while keeping [18F]FDG yield >=10mCi. Improvements in target yield, reducing target unload time, reducing the synthesis time, and a faster QC injection have reduced the average cycle time of producing a purified and qualified dose from < 45 [min] to < 30 [min].
Dual Dose Syringe - Proof of concept for the production of a dual dose syringe (2 doses, > 10 [mCi]) has been achieved. In a mini-batch process, a dose of sufficient activity so as to allow for the injection of two patients (one at 15 [min] and one at 15-45 [min] after production) has been produced using a single disposable dose synthesis card (DSC). Upgrades and improvements in both the ABT radioisotope generator and chemistry production module (CPM) were necessary to produce a system capable of producing a dual dose syringe.
[18F]NaF Dose Synthesis Card - A comparative imaging study was performed for sodium fluoride F-18 injection dose ([18F]NaF) manufactured with the ABT BG75 system and a commercial source. [18F]NaF was manufactured from the ABT BG75 system at the University of North Carolina in less than 30 minutes (ready-to-use, isotonic and sterile syringe) and passed the established release criteria for visual inspection, radiochemical identity/purity, radionuclidic identity/purity, pH, sterility and bacterial endotoxins. Imaging and biodistribution results based on standard uptake value (maximum and mean) showed that the accumulation in vivo is equivalent between the ABT dose and the commercial dose for all conditions tested.
[18F]FMISO Dose Synthesis Card - Proof of concept for the synthesis of [18F]FMISO using the present disposable dose synthesis card (DSC) configuration in the ABT BG75 system, and purification using solid phase synthesis and preparative HPLC has been achieved at Oklahoma University. Successful assessment of the radiochemical purity/identity, chemical purity and residual solvent determination in the final [18F]FMISO product using ion exchange HPLC has also been achieved using the existing Quality Control Module hardware.
The supporting white papers can be found here.
All above mentioned features are WIP, and subject to our standard quality evaluation processes and country-dependant government body regulatory approval before final release as approved products.
Mark Khachaturian Ph.D