Radionuclide Production and Radiochemistry Core Description Core

放射性核素生产和放射化学核心描述核心

• 批准号: 10263251
• 负责人: Jonathan W Engle
• 金额: $ 29.08万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-14 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10263251
• 关键词: 90Y; Adopted; Alloys; Anatomy; Area; Biological Assay; Cells; Clinical; Clinical Trials; Communities; Complex; Confounding Factors (Epidemiology); Coupled; Cyclotrons; Discipline of Nuclear Medicine; Disease; Dose; Emission-Computed Tomography; Ensure; Environment; Equipment; Gases; Germanium; Image; Immunologics; Immunotherapy; In Vitro; Infrastructure; Institutes; Institution; International; Investigation; Isotopes; Label; Laboratories; Liquid substance; Medical; Medical Research; Methodology; Methods; Molecular; Molecular Target; Particle Accelerators; Pharmacologic Substance; Pharmacology; Phase; Physics; Physiological; Positron-Emission Tomography; Process; Production; Protons; Quality Control; Radiation; Radiation Dose Unit; Radioactivity; Radiochemistry; Radioisotopes; Radiolabeled; Radiology Specialty; Radionuclide therapy; Radiopharmaceuticals; Research; Role; Route; Ships; Site; Solid; Source; Targeted Radiotherapy; Techniques; Tissues; Translating; Universities; Wisconsin; animal imaging; base; biological systems; cGMP production; cancer therapy; design; detector; deuteron; dosimetry; immunomodulatory therapies; immunoregulation; in vivo; instrument; interest; irradiation; next generation; novel; pre-clinical; radiochemical; radiotracer; response; segregation; square foot; targeted agent; theranostics; tumor

PROJECT SUMMARY – RADIONUCLIDE PRODUCTION AND RADIOCHEMISTRY CORE 1 The Department of Medical Physics controls three different particle accelerator laboratories equipped with a variety of irradiation, radiochemistry, and radioanalytical equipment that will be used to investigate the symbiotic effects of targeted radiotherapy (TRT) and the immunological methodologies of Projects 1-4. The Cyclotron Laboratories’ principle site in the Wisconsin Institutes of Medical Research (WIMR) hosts a General Electric PETtrace 16-MeV proton / 8-MeV deuteron cyclotron surrounded by 4000 square feet of laboratory space used for radiochemical and accelerator research, as well as the routine production and international distribution of numerous radionuclides to a global customer base. The cyclotron laboratory infrastructure accommodates tens of Ci-quantities of radioactivity in automated processes using homemade and commercial equipment and is internationally established as a leader in solid, liquid, and gas phase accelerator targetry, primarily for positron- emission tomography (PET) radionuclide production. Spectroscopic/spectrometric analysis is accomplished with multiple high purity germanium detectors and a variety of configurable electronic equipment. Most recently, our research into alloy targetry for small, medical accelerators has enabled us to increase production of several radionuclides of interest to previously unprecedented levels. This laboratory currently produces 89Zr, 76/77Br, 86Y, 52gMn and more than two dozen other radionuclides on a weekly basis for local use and shipment to over 60 collaborators, colleagues, pharmaceutical companies, and globally premier research institutions in the US and abroad. The laboratory also hosts biosafety cabinets inside radiation areas for in vitro study of the unique radionuclides we produce, adjacent to the laboratory space of the Small Animal Imaging Core. Finally, the Department of Radiology recently finished construction of a GMP Radiopharmacy lab. The Radiopharmaceutical Production Facility (RPF) is situated within the WIMR complex across the hall from the cyclotron facility. It houses a new manufacturing area designed for the production of cGMP radiopharmaceuticals. This area is equipped with multiple hot cells and synthesis modules and includes multiple quality control instruments to accommodate segregation of clinical and preclinical production activities. A dispensing area designed in compliance with USP <797> has the capability to compound and distribute radiopharmaceuticals. Although clinical trials are not the aim of the PO1, we have the ability to rapidly translate the treatment paradigms discovered and developed within the PO1 to the clinical trial stage. The specific aim of the Radionuclide Production and Radiochemistry Core (RPRC) is to directly produce and supply pure imaging and therapy radionuclides and radiochemically synthesize all imaging/therapy/immunomodulatory doses of radiopharmaceuticals for use in the four PO1 Projects. This core will also be responsible for obtaining adequate amounts of alpha- and beta-emitting isotopes like Ac-225, Y-90 and Lu-177 from external commercial sources and/or the Oak Ridge National Laboratory.

项目摘要 - 放射性核素生产和放射化学1 医学物理部控制了三个配备有一个的不同粒子加速器实验室 将用于研究共生的辐射，放射化学和放射分析设备的种类 靶向放射疗法（TRT）和项目1-4的免疫学方法 Wissonsin Instittes of Medical Research（WIMR）的实验室主要网站主持通用电气 PETTRACE 16-MEV质子 / 8-Mev Deuteron Cyclotron，周围是4000平方英尺的实验室空间 用于放射化学和加速器研究，以及常规生产和国际分布 全球客户的许多放射性核素。 使用自制和商业设备自动化过程中放射性的CI量，IS是IS is is is is is is is is is is is is is is is is is。 作为固体，液体和气相加速器靶向的领导者，国际上建立的主要是正电子的 发射断层扫描（PET）放射性核素的产生。 多个高纯净锗探测器和各种可配置的电子设备。 针对小型医疗加速器的合金目标研究使我们能够增加几种的生产 先前未经预科水平的放射性核素目前产生89ZR，76/777Y，86Y，86Y 52gmn和超过其他放射性核素在 美国合作者，同事，制药公司和美国全球总理研究所INSEACH Institute和 国外。 我们产生的放射性核素，毗邻小动物成像芯的实验室空间。 GMP放射性药物实验室的放射学部完成了放射线 生产设施（RPF）位于大厅的WIMR综合体中，从回旋器设施中。 为CGMP放射性药物生产而设计的新制造区域。 具有多个热单元和合成模块，并包括多种质量控制仪器以适应 临床和临床前生产活动的隔离。 <797>具有复合和分布放射性药物的能力。 PO1的目的，我们有能力快速翻译内部发现和发展的治疗范例 PO1到临床试验阶段。 （RPRC）是直接生产和提供纯成像和治疗放射性核素和放射化学合成 所有成像/治疗/免疫调节剂量的放射性药物用于四个PO1项目 核心还将负责获得足够数量的α和β发射同位素，例如AC-225， 来自外部商业来源和/或橡树岭国家实验室的Y-90和LU-177。