Commercialization of a benchtop radiosynthesizer for the production of PET probes

PROJECT SUMMARY ABSTRACT Positron Emission TomographyPETis a molecular imaging modality that utilizes radiolabeled moleculesprobesto target and measure biological processesResearchers can use the same probes to examine microorganismscellsand miceas they do in patientsto visualize and characterize the biology of diseasemonitor its progressionand evaluate therapeutic efficacyOverPET probes have been developed to help answer a variety of biological questionsbut only the glucose analogF FDG is routinely used for molecular imaging diagnostics in patient careThere is still an unmet need to develop additional probes which can annotate key aspects of diseaseincluding those in which the diagnostics share common targets with drugsto truly establish it as a key technology for realizing improved treatment and monitoring in personalized medicineThe clinical translation of next generation PET probes is in part hampered by the high cost and complexity of the infrastructurespecialized equipmentand skilled personnel required for synthesisOvercoming these hindrances to PET probe developmentoptimizationand routine production is necessary to facilitate the entry of novel PET probes into clinical research and trialsand to select those with value as companion biomarkersA decentralized approach to PET radiotracer development is required to give scientists and clinicians the freedom to determine the probes they want to use to best solve the problems of their interestThis goal can be achieved by building a benchtopPC controlledmicrofluidic based commercial device for the on demand production of PET probesPhase I of this project answered basic commercial feasibility questions about the underlying microfluidic chip technologyPhase II addressed technological challenges inherent in creating a commercial microscale radiosynthesizer so the synthesis of diverse PET probes for brain imaging can be performed in a simple and convenient manner at a low costThis Phase IIB proposal aims to bring the prototype to a commercial design and synthesize novel neuro probes with full quality control validation to prepare its use for the clinical manufacturing of PET probes under cGMP guidelinesShifting to a point of research point of care model is a transformational solution that removes the limitations imposed by the traditional model of PET probe productionTo facilitate a paradigm shift in the enablement of novel PET probes for the clinical communitya fundamental change in production ideology and infrastructure re imagining is requiredan affordablebenchtopself shieldedcompacteasy to usemicrofluidic based radiosynthesis platform for the on demand production of PET probes will provide expanded access to PET for researchers and clinicians in academia and industry