An integrated radiopharmaceutical synthesis system

集成放射性药物合成系统

• 批准号: 7390051
• 负责人: JULIE L SUTCLIFFE
• 金额: $ 49.73万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7390051
• 关键词: Animal Model; Arts; Class; Clinical Research; Development; Diagnosis; Diagnostic Imaging; Documentation; Faculty; Goals; Hospitals; Human; Image; Investigation; Label; Laboratories; Malignant Neoplasms; Medical center; Pathway interactions; Patients; Positron; Positron-Emission Tomography; Production; Radiolabeled; Radiopharmaceuticals; Range; Reaction; Regulation; Staging; System; Therapeutic Agents; Translational Research; United States Food and Drug Administration; United States National Institutes of Health; base; design; human subject; in vivo; instrumentation; man; molecular imaging; novel; novel diagnostics; novel strategies; nucleophilic substitution; outcome forecast; radiotracer

DESCRIPTION (provided by applicant): The goal of this proposal is to install instrumentation for the production of non-commercially available radiolabeled imaging agents suitable for human use at the UC Davis Medical Center. UC Davis Medical Center is completing a Good Manufacturing Practice (GMP) laboratory at its main hospital campus in Sacramento. This GMP laboratory is a multi-use, 6 manufacturing suite, Class 10,000 facility. We propose to incorporate a commercial radiopharmaceutical synthesis system for the production of PET radiopharmaceuticals that has been designed complete with shielding enclosures allowing the production of radiopharmaceuticals to take place under full GMP compliance. The synthesis system allows the automated production of PET radiopharmaceuticals labeled with the positron emitter 18F via nucleophilic substitution reactions. The complete integrated system includes all necessary documentation for compliance with FDA GMP regulations as well as USP 797. As the NIH roadmap calls for an emphasis on translational research and has identified molecular imaging as a priority, UC Davis is proposing to build a bridge from functional and molecular imaging in animal models to humans. It is clear that currently a significant gap persists with regard to clinical and research molecular imaging in human subjects. This gap relates to the lack of access to non-commercially available molecular imaging radiopharmaceuticals for clinical and research human PET. Installation of this system into our state-of-the-art GMP facility will be the first step taken to facilitate bridging this gap. The system will be used to support clinical research ranging from cancer to cellular therapies, and will also be used to perform first in man studies of a range of new diagnostic and therapeutic agents under development by UC Davis faculty. The field of molecular imaging seeks to discover new approaches to imaging specific biologic targets and pathways in vivo, with the ultimate goal of providing patient-specific and molecularly-based diagnosis, prognosis and therapy. The faculty at UC Davis have expertise in the design of molecularly-targeted imaging agents that are currently under investigation in animal models with several leads at the translational stage. The proposed integrated system will allow us to synthesize both established and novel PET radiopharmaceuticals as diagnostic imaging agents complying with both FDA GMP as well as USP 797 for use in human imaging studies.

描述（由申请人提供）：该提案的目标是在加州大学戴维斯分校医学中心安装仪器，用于生产适合人类使用的非市售放射性标记显像剂。加州大学戴维斯分校医学中心正在其位于萨克拉门托的主院区建设良好生产规范 (GMP) 实验室。该 GMP 实验室是一个多用途、6 个制造套件、10,000 级设施。我们建议采用商业放射性药物合成系统来生产 PET 放射性药物，该系统设计有屏蔽外壳，允许放射性药物的生产在完全符合 GMP 的情况下进行。该合成系统允许通过亲核取代反应自动生产用正电子发射体 18F 标记的 PET 放射性药物。完整的集成系统包括符合 FDA GMP 法规以及 USP 797 的所有必要文件。由于 NIH 路线图呼吁强调转化研究，并将分子成像确定为优先事项，加州大学戴维斯分校提议建立一座从动物模型的功能和分子成像到人类的桥梁。显然，目前在人类受试者的临床和研究分子成像方面仍然存在显着差距。这一差距与缺乏用于临床和研究人类 PET 的非市售分子成像放射性药物有关。将该系统安装到我们最先进的 GMP 设施中将是缩小这一差距的第一步。该系统将用于支持从癌症到细胞疗法的临床研究，还将用于对加州大学戴维斯分校教师正在开发的一系列新诊断和治疗药物进行首次人体研究。分子成像领域致力于发现体内特定生物靶点和通路成像的新方法，最终目标是提供患者特异性和基于分子的诊断、预后和治疗。加州大学戴维斯分校的教师拥有分子靶向显像剂设计方面的专业知识，目前正在动物模型中对这些显像剂进行研究，并有几项线索处于转化阶段。所提出的集成系统将使我们能够合成既定的和新型的 PET 放射性药物作为诊断成像剂，符合 FDA GMP 和 USP 797，用于人体成像研究。