Preclinical Therapeutics Core

临床前治疗核心

基本信息

批准号：
10449309
负责人：
Michael David Levin
金额：
$ 23.25万
依托单位：
PROTEOGENOMICS RESEARCH INSTIT/SYS/ MED
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-08 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10449309
关键词：
Agreement Analytical Chemistry Animal Experiments Animal Model Animal Testing Animals Antibodies Antibody Formation Antibody-drug conjugates Biological Assay Biology Blood Vessels California Calorimetry Caveolae Chelating Agents Chemistry Clinical Clinical Trials Collaborations Consultations Contracts Cyclic GMP Development Dextrans Disease model Doctor of Philosophy Ensure Enzymatic Biochemistry Equipment Exclusion Fluorescence Fluorescence Polarization Hybridomas Hydrophobic Interactions Image Immunoconjugates Industrialization Institution Ion-Exchange Chromatography Procedure Lead Life Ligands Lung Neoplasms Lung diseases Mass Spectrum Analysis Medicine Methods Molecular Weight Monoclonal Antibodies Mus Nuclear Magnetic Resonance Pharmaceutical Preparations Pharmacologic Substance Phase Platinum Preparation Procedures Process Production Property Protocols documentation Quality Control Radio Radioactive Iodine Radioactive metal Radioisotopes Reagent Recombinant Proteins Refractive Indices Reproducibility Research Research Activity Research Institute Research Project Grants Research Support Resources Services Solid Neoplasm Spectrophotometry Spectroscopy, Fourier Transform Infrared Surface Plasmon Resonance Synthesis Chemistry System Technical Expertise Technology Technology Transfer Testing Therapeutic Therapeutic Agents Therapeutic antibodies Time Training Universities Validation Yang antibody conjugate antibody engineering cGMP production chemotherapy clinical imaging clinical translation detector experience experimental study humanized antibody imaging agent instrument light scattering member novel pre-clinical protein expression proteogenomics scale up targeted imaging therapeutic evaluation tumor

项目摘要

CORE B PROJECT SUMMARY Core B Preclinical Therapeutics will provide purified antibodies for conjugation and use in Projects 1 and 2 to generate novel caveolae-targeting imaging and therapeutic agents. The Core will also provide analytical services to ensure quality control of reagents that will be used for preclinical animal testing. Antibodies generated in Core B will be conjugated to radionuclides in Core D for use in Project 1. Antibodies will be provided to Project 2 for conjugation to various chemotherapies, and testing in preclinical metastatic models of disease. Reagents developed in Projects 1 and 2 will be rigorously evaluated for quality control using analytical services provided by Core B prior to use in any animal studies. Core B will also provide support services and guidance for the cGMP production of the humanized antibody and therapeutic agents destined for clinical trials, including scale-up, process development, validation, batch testing, compliance, and providing technical expertise as needed to ensure successful technology transfer and quality manufacturing of finished goods.

核心B项目摘要核心B临床前疗法将提供纯化的抗体，用于在项目1和2中使用和使用产生新颖的小窝靶向成像和治疗剂。核心还将提供分析确保将用于临床前动物测试的试剂的质量控制。抗体在核心B中产生的核心核素将在核心D中偶联，以用于项目1。向项目2提供了与各种化学疗法的结合，并在临床前转移模型中进行测试疾病。项目1和2中开发的试剂将经过严格评估，以使用分析进行质量控制在任何动物研究中使用之前由核心B提供的服务。核心B还将提供支持服务，针对人源化抗体和治疗剂的CGMP产生的指南，注定为临床试验，包括扩展，过程开发，验证，批处理测试，合规性以及提供技术根据需要的专业知识，以确保成功的技术转移和质量制造成品。