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J Nucl Med. 2008; 49 (Supplement 1):300P
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Radiopharmaceutical Chemistry: New Chemistry-Other

New Chemistry-Other Posters

Evaluation of an automated modular radiochemistry synthesis unit for process development

S. Dragotakes1, T. Shoup1 and D. Elmaleh1

1 Division of Nuclear Medicine & Molecular Imaging, Massachusetts General Hospital, Boston, Massachusetts

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Objectives: Automation of [18F] radiochemistry syntheses is critical for the successful production of clinically useful amounts of PET radiopharmaceuticals. PET radiochemistry development demands flexibility to optimize yields and streamline processes. Our objective was to evaluate a new and novel modular approach to automation of PET radiochemistry with respect to the development of a new [18F]-(Fluorophenyl)triphenylphosphonium Chloride (BfPET) cardiac perfusion agent.

Methods: Our new approach was initiated with the acquisition of a Modular-LAB radiochemistry synthesis system built by, Eckert & Ziegler, Berlin. Initial system consisted of a standard heater reactor, Peltier heating/cooling reactor, solenoid valve modules, and stopcock valve modules. Individual modules were arranged for the [18F] - BFPET synthesis and connected by an integrated BUS-system for Plug & Play operations as directed by the Modular-LAB software and managed via graphical user interface. Initial process consisted of a direct fluorination of a nitro-precursor in the 250°C reactor, followed by SPE clean-up via QMA cartridge, and C-18 cartridge product separation. Following ethanol elution off C-18 cartridge, product was delivered into the Peltier reactor for additional heating under vacuum to remove ethanol. Final formulation was formed in normal saline and passed through 0.2µ sterilizing filter into aseptically prepared final product vial. After initial development run results, final product separation was changed to binary gradient semi-prep HPLC with addition of an integrated HPLC-module with injection valve, activity detector, and UV detector for product separation.

Results: After final configuration 5 validation runs were successfully performed.

Conclusions: Flexibility of the Modular -Lab system allowed for interchange of semi-prep HPLC modules and development of a radiochemical process method without major engineering of software or hardware.





This Article
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Right arrow Articles by Dragotakes, S.
Right arrow Articles by Elmaleh, D.
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Right arrow Articles by Dragotakes, S.
Right arrow Articles by Elmaleh, D.