Preclinical Therapeutics Core

核心B项目摘要 Core B临床前治疗公司将提供纯化的抗体，供在项目1和2中结合和使用 产生新的小凹靶向成像和治疗剂。核心还将提供分析 确保用于临床前动物试验的试剂的质量控制的服务。抗体 在核心B中产生的抗体将与核心D中的放射性核素结合，用于项目1。抗体将 提供给项目2用于与各种化疗相结合，并在临床前转移模型中进行测试 疾病。将严格评估项目1和项目2中开发的试剂的质量控制，使用分析 在任何动物研究中使用之前由Core B提供的服务。核心B还将提供支持服务和 用于临床试验的人源化抗体和治疗剂的cGMP生产指南 包括纵向扩展、流程开发、验证、批量测试、合规性和提供技术支持 确保成功的技术转让和成品的高质量制造所需的专业知识。

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.