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

用于探针生产的通用电气 (GE) Healthcare FX2 Mel/M 自动反应模块

• 批准号: 10414705
• 负责人: Michael L. Nickels
• 金额: $ 60万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414705
• 关键词: Area; Carbon; Clinical; Clinical Trials; Cyclotrons; Development; Equipment; Exposure to; Funding; Healthcare; Individual; Institutes; Investigational New Drug Application; Modeling; Nuclear; Pharmacy facility; Process; Production; Radioactivity; Radiology Specialty; Radiopharmaceuticals; Reaction; Request for Applications; Research; Research Personnel; Residual state; Resource Sharing; Resources; Technical Expertise; Time; United States National Institutes of Health; Universities; Washington; Work; bench to bedside; flexibility; instrument; medical schools; pre-clinical; research and development

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.

本申请申请资金用于购买最先进的自动辐射合成模块和