Commercialization of a Microscale, Point of Use Radiosynthesis Device for the Development and Production of PET Probes

Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (probes) to target and measure biological processes. Basic scientists can use the same probes to examine microorganisms, cells, and mice as they do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy. Although over 1,600 PET probes have been developed to help answer a variety of biological questions, and could potentially lead to new diagnostic and therapeutic tools for further study, only the glucose analog 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG) is routinely used. This limitation exists because of the centralized radiopharmacy approach to PET probe production, with its complexity, high infrastructure cost, and necessity of specialized equipment and skilled personnel. An alternative, decentralized approach to PET probe development is required to give scientists the freedom to determine what probes they want to use to best solve the problems of their interest. This goal can be achieved by building a benchtop, computer-controlled, microfluidic chip-based commercial device for the on-demand production of PET probes. Phase I of this project answered basic commercial feasibility questions about the underlying Electro- Wetting-On-Dielectric (EWOD) microfluidic chip technology, including: (1) the suitability of EWOD chips based on printed-circuit-board (PCB) technology to reduce costs of radiosynthesis chips; (2) the repeatability of synthesis process parameters and outcomes; (3) coupling of a miniature purification system to the prototype chip; and (4) establishing the versatility of the platform through synthesis of additional PET compounds other than [18F]FDG. Phase II will produce a commercial prototype platform for the point-of-use production of PET probes. This platform will include: (1) a computer-based control system; (2) an inexpensive, disposable, probe- specific cassette of chips and reagents; and (3) a compact, benchtop housing that serves to shield the end user from radiation. As an eventual product, a library of cassettes will be developed based on customer needs for different probes. Shifting to a point-of-research/point-of-care model is a transformational solution that circumvents the limitations imposed by the centralized model on probe production, cost, and diversity. By empowering scientists and clinicians to control the development and use of PET probes, they are able to focus on processes that they believe are most important for the environmental and biological sciences.