Positron Emission Tomography (PET) is regarded as a standard of care in the management of multiple types of cancer. Availability of this procedure relies on a steady supply of a radioactive contrast agent [F- 18]Fluoro-2-deoxy-d-glucose (FDG). Due to the inherent short half-life (110 min), multiple batches of FDG are typically produced at multiple sites on daily basis. Quality Control (QC) of FDG remains the most labor-, skill- and risk-intensive part of the production process. Reliance of QC on manual operation, subjectivity and untraceable records, limits the number of FDG batches that may be produced per day per facility, which in turn limits availability of PET imaging to cancer patients. Trace-Ability has taken an unconventional approach to QC automation (called Tracer-QC) which relies on optical measurements by a microplate reader for most of the QC tests. The 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 pipettor. Most of the QC tests have been already enabled by Trace-Ability relying on NCI Phase I SBIR and other funding. Radiochemical purity and chemical identity QC tests will be enabled during Phase II by integration of an HPLC component into the plate reader/pipettor system in a seamless way which allows the user to use a single sample to obtain a single report on 10 QC parameters. The integrated solution will then be validated for use in clinical FDG production. The second component of the Phase II project will focus on setting up reliable production of disposable Tracer-QC kits at commercial scale. Upon achievement of the above aims, Trace-Ability will be in position to offer FDG manufacturers a fully-automated QC solution that has been completely validated. This is critical since production of short- lived PET tracers has extremely low tolerance for failure. Optimized production processes will yield Tracer-QC kits that are not only optimized for reliability, but also for cost, maximizing the commercial potential of the Tracer-QC business that relies on recurring kit revenues from the growing install base. Finally, having an FDG QC solution with on-board HPLC enables expansion of Tracer-QC to any other PET tracers without further revisions of the stationary hardware, making it a true scalable platform. The impact in the field of Oncology will be manifested in increased availability of FDG scans and facilitation of new tracer development. Upon completion of the project Trace-Ability plans to use the new platform to develop QC methods for more PET tracers such as [F-18]FDOPA (brain tumors), [F-18]FLT (general oncological tracer), [C-11]Choline (prostate tumors), [Ga-68]DOTATOC (endocrine tumors).

Public Health Relevance

Trace-Ability is proposing automation of radio-pharmaceutical Quality Control. Successful completion of this project will enable dramatic improvements in efficiency of production of the most common radio- pharmaceutical in Positron Emission Tomography (PET) ? Fludeoxyglucose F 18 (FDG). Resulting increase in supply of FDG will in turn increase availability of FDG PET, which is a standard of care in management of multiple types of cancer.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Evans, Gregory
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Trace-Ability, Inc.
Culver City
United States
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