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: 10416050
• 负责人: Jonathan W Engle
• 金额: $ 28.51万
• 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/10416050
• 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核心1 医学物理系控制着三个不同的粒子加速器实验室，配备了 将用于研究共生生物的各种辐射、放射化学和放射分析设备 靶向放射治疗(TRT)的效果和项目1-4的免疫学方法。回旋加速器 实验室的主要地点在威斯康星州医学研究院(WIMR)，拥有通用电气 PETTRACE 16 MeV质子/8 MeV氘回旋加速器，周围有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销 向全球客户群提供大量放射性核素。回旋加速器实验室的基础设施可容纳数十个人 使用自制和商用设备的自动化过程中的放射性Ci-量，以及 作为固体、液体和气相加速器靶标的国际领先企业，主要用于正电子- 发射断层扫描(PET)放射性核素生产。光谱分析/光谱分析用 多个高纯度锗探测器和各种可配置的电子设备。最近，我们的 对用于小型医用加速器的合金靶材的研究使我们能够增加几种 令人感兴趣的放射性核素达到了前所未有的水平。该实验室目前生产89Zr、76/77Br、86Y、 每周52gMn和20多种其他放射性核素，供当地使用并运往60岁以上 合作者、同事、制药公司和全球顶尖研究机构在美国和 出国。该实验室还在辐射区域内设有生物安全柜，用于体外研究独特的 我们生产的放射性核素，毗邻小动物成像核心的实验室空间。最后， 放射科最近完成了GMP放射性药物实验室的建设。放射性药物 生产设施(RPF)位于回旋加速器设施对面的WIMR综合体内。它容纳了很多人 设计用于生产cGMP放射性药物的新生产区。这个区域装备齐全 具有多个热室和合成模块，并包括多个质量控制仪器，以适应 临床和临床前生产活动的分离。按照USP设计的配药区 &lt；797&gt；具有合成和分发放射性药物的能力。尽管临床试验并不是 PO1的目标是，我们有能力快速转换在 PO1进入临床试验阶段。放射性核素生产的特定目标和放射化学核心 (RPRC)是直接生产和供应纯成像和治疗放射性核素，并通过放射化学合成 用于四个PO1项目的所有放射性药物的成像/治疗/免疫调节剂量。这 CORE还将负责获得足够数量的α和β发射同位素，如Ac-225， Y-90和Lu-177来自外部商业来源和/或橡树岭国家实验室。