Commercialization of a Benchtop Radiosynthesizer for the Production of PET Probes

DESCRIPTION provided by applicant Positron Emission Tomography PET is a molecular imaging modality that utilizes radiolabeled molecules andquot probesandquot to target and measure biological processes Basic scientists can use the same probes to examine 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 PET probes have been developed to help answer a variety of biological questions including many specific to understanding the structure and function of the human brain only the glucose analog F FDG is routinely used for molecular imaging diagnostics in patient care today This limitation exists because of the centralized approach to PET probe production necessitated by the high cost of infrastructure specialized equipment and skilled personnel required for synthesis Overcoming these hindrances to PET probe development optimization and routine production is necessary to facilitate the entry of numerous other promising PET probes into clinical research and trials and to select those with value as companion biomarkers A 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 PC 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 Phase II seeks to leverage previous research to address technological challenges inherent in creating a commercial microscale chip based radiosynthesizer so the synthesis of diverse PET probes for clinical brain imaging can be performed in a simple and convenient manner at a low cost Key objectives include development of an approach for large scale manufacturing of low cost cGMP compliant EWOD chips design of an automated post synthesis system including HPLC fraction collection formulation and aliquoting of product for downstream quality control development of a clinical version of the software platform and electronic control system and development of proof of concept cGMP kits for the synthesis of a variety of probes for brain imaging As an eventual product a library of chips 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 removes 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 PUBLIC HEALTH RELEVANCE Novel molecular imaging modalities to measure biochemical and cellular events in patients are needed in personalized medicine to transform the care of patients with brain disorders The goal of this proposal is to develop an affordable compact chip based device to produce PET probes thereby enabling scientists to image diverse biological systems by eliminating barriers that currently limit probe availability and diversity Te scientific yield from this may lead to improved therapies for the pathophysiology of brain disorders significantly affecting public health