A General Electric (GE) Healthcare FX2 Mel/M Automated Reaction Module for Probe Production

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This application request funds for the purchase of a state-of-the-art automated radiosynthesis module and the required hotcells needed to safely use and house the module components. This unit will be housed in the Washington University School of Medicine (WUSM) Mallinckrodt Institute of Radiology (MIR) Cyclotron Facility and Nuclear Pharmacy as a Shared Resource of our NIH sponsored researchers. The proposed instrument is the General Electric (GE) Healthcare TRACERlab FX2 MeI/M automated reaction module with accompanying Comecer hotcells. The addition of this equipment will allow a rapid escalation of research, development, and routine production of materials needed by a variety of NIH supported projects. The intent of this equipment is to allow both pre-clinical and clinical projects to have a flexible and routinely available piece of equipment to help further their research objectives. This specific model of automated reaction module was selected due to its unique capability to perform multiple Carbon-11 productions over the course of a single day without the need for users to expose themselves to any residual radioactivity. The units are also identical to existing production units housed within the Cyclotron Facility’s GMP production area, which are not available to researchers as shared instruments. The ability for researchers to utilize identical instruments as those used for routine clinical production, allows for a streamline bench-to-bedside process to be built in from the start of a radiopharmaceuticals developmental path. This will aid in shortening the time required for translational work to optimize a radiopharmaceutical’s production process, since the process will be directly transferrable to the GMP production area. Shortening this time will mean more Investigational New Drug Applications (INDs) can be developed and submitted to the FDA, which, in turn, will result in an increase in the numbers of clinical trials our investigators can undertake. In this application, numerous NIH-supported projects are highlighted that will directly benefit in multiple ways from the acquisition of this resource. This application includes a description of each NIH- funded project that would directly benefit from this resource, a description of the scientific and technical expertise of those individuals who will oversee and manage the resource, a plan for administration, and a strong commitment from Washington University to provide support for the resource.