Development of completely automated quality control procedures for 4 PET Imaging tracers that will increase production throughput and lead to expanded diversity of PET imaging available to patients.

Long term objective of this project is increased availability of Positron Emission TomographyPETimaging to patients across different disease areasThe approach focuses on eliminating complexity and quality risks associated with production of radioactive contrast agentsPET tracers relied upon in neurology and oncologyThe specific solution developed in this project is a platform that will afterwards deliver the same benefits in production of PET tracers used in an expanded variety of disease areasPET Tracers rely on radionuclides with inherently short half lives such as FminGaminthat have to be produced multiple times a day from a cyclotron or generatorQuality ControlQCof PET tracers is by far the most laborskilland risk intensive part of the cGMP production processIt requires assessment ofdifferent parameters for the PET tracer to be released for patient useThe complex current state of PET tracer QC presents a barrier to the expansion of PET imagingparticularly to smaller hospitals and clinics in the rural USoften limits the number of PET tracers that may be produced in one facilityand ultimately limits the availability of PET imaging to patientsThe innovation is in the disposable kit that enables multiple tests from a single sample on a single platform composed of a microplate reader and automated pipettorTracer QC has been successfully benchmarked with FDGthe most common PET tracer used in multiple applicationsIt has delivered the desired simplificationefficiency and traceability of dataFour PET tracers chosen for this project areFFlorbetabenFDA approved PET tracer for amyloid imaging in Alzheimer s Disease diagnosticsFFlortaucipira tau protein marker with highest predictive potential for Alzheimer s Disease and other neurodegenerative diseases such as TBI CTEFFMISOleading marker for detection and management of sarcomasGaDOTATATEFDA approved PET tracer for neuroendocrine tumorsThe impacts of this work will beimproved availability of thesePET tracers to patientsstreamlined procedures for transition of future tracers onto Tracer QC platformandfreed up capacity in PET production facilities to add more PET tracers to their offerings to the imaging centersEach Phase I Specific Aim focuses on one ofriskiest new testsMilestone is experimental demonstration of the desired limit of detectionSpecific AimAcetoneLODppmSpecific AimDMSOLODppmPhase II Specific AimsClinical Production of new tracer using Tracer QC for quality controlFFlorbetabenFFlortaucipirFFMISOGaDOTATATEMilestones areaTracer QC method validated for each PET tracer QC andbIND NDA amendment filedThe project will yield a fully automated QC solution that has been validatedde risked and is positioned for easy implementation with DMF cross reference fornew tracers The output of the project is a platform technology expected to simplify production not only for thedemonstrated neurology and oncology PET tracers but for many others that enable Positron Emission TomographyPETimaging across multiple disease areasBesides simplification this innovation will deliver improvements in regulatory complianceboth of which are expected to lead to much higher throughput in PET tracer production facilitieswhich translates into increased availability of a diverse range of PET imaging to multiple groups of patientsIt is also expected to be an important driver in development of new PET tracers for imaging needs that have not been addressed yet