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

该申请要求资金用于购买最先进的自动放射合成模块和 所需的热室需要安全地使用和容纳模块组件。该单位将设在 华盛顿大学医学院（WUSM）马林克罗特放射学研究所（MIR）回旋加速器设施 和核药学作为我们NIH赞助研究人员的共享资源。拟议的文书是 General Electric（GE）Healthcare TRACERlab FX 2 MeI/M自动化反应模块 Comecer热室。该设备的增加将使研究、开发和 日常生产各种NIH支持项目所需的材料。该设备的目的是 允许临床前和临床项目都有一个灵活的和常规可用的设备，以帮助 推进他们的研究目标。选择这种特定型号的自动化反应模块是因为其独特的 能够在一天内执行多个碳-11生产，而无需用户 暴露在任何残余的放射性中这些装置也与现有的生产装置相同， 在回旋加速器设施的GMP生产区域内，研究人员无法共享 仪器.研究人员能够使用与常规临床研究相同的仪器 生产，允许从一开始就建立一个精简的工作台到床边的过程， 这将有助于缩短翻译工作所需的时间， 优化放射性药物的生产过程，因为该过程将直接转移到GMP 生产区。缩短这一时间将意味着更多的研究性新药申请（IND）可以在 开发并提交给FDA，这反过来将导致临床试验数量的增加， 调查人员可以进行。在本申请中，突出显示了许多NIH支持的项目，这些项目将直接 从这一资源的获取中获益匪浅。此应用程序包括每个NIH的描述- 将直接受益于这一资源的资助项目， 这些人将监督和管理资源，管理计划，以及一个强大的 华盛顿大学承诺为该资源提供支持。

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.