RADIOPHARMACY AND ASSAYS

核心B核心总监Colcher，David首席调查员：Raubitschek，Andrew 说明： 放射性药物和评估核心(核心B)的主要目标是支持项目1： 放射免疫治疗：临床研究，项目2：用抗CEA抗体进行治疗，以及 项目3：通过提供专业知识和设施制备放射性标记的CEA靶向免疫疗法 治疗和成像试剂的抗体和质量控制。~(90)Y放射性标记 嵌合/人源化T84.66抗CEA抗体将用于结肠癌和肺癌的临床试验 Satients和Y-90放射性标记赫赛汀将用于希望之城的乳腺癌患者 国家医学中心，铟-111放射性标记嵌合/人源化T84.66抗体，阿瓦斯丁和 赫赛汀将用于成像和剂量学研究。放射性药房将通过以下方式支持项目1 提供放射性标记抗体，并将为这些试剂提供质量控制。 该核心还负责分析患者(和动物)的血液样本，以评估血液 受控产品的清净度和稳定性。病人的血清样本也被分析，以监测 患者对注射的抗体构建的免疫反应。 核心B还执行所有抗体的放射性标记，工程抗体，化学修饰 用于临床前、体外和体内使用的抗体和半抗原。编制本报告所涉及的程序 放射性药物包括络合物结合物化学和结合物以及抗体 无线电标记。作为其核心活动的一部分，放射性药房还开发出单抗。 为在cGMP设备中制备的临床级材料构建偶联方法 第一阶段试验。 在本申请中，核心B将与所有三个项目以及核心A、C、D和E相关联。

Core B core Director Colcher, David Principal investigator: Raubitschek, Andrew DESCRIPTION: The principal objective of the Radiopharmacy and Assays Core (Core B) is to support Project 1: Radioimmunotherapy: Clinical Studies, Project 2: Pretargeting with anti-CEA Antibodies for Therapy, and Project 3: CEA Targeted Immunotherapeutics by providing expertise and facilities to prepare radiolabeled antibodies and quality control for therapeutic and imaging reagents. Yttrium-90 radiolabeled chimeric/humanized T84.66 anti-CEA antibody will be used in the clinical trials for colon and lung cancer satients, and yttrium-90 radiolabeled Herceptin will be used in breast cancer patients at the City of Hope National Medical Center, lndium-111 radiolabeled chimeric/humanized T84.66 antibody, Avastin and Herceptin will be used for imaging and dosimetry studies. The radiopharmacy will support Project 1 by providing the radiolabeled antibodies and will provide quality control for these reagents. This Core is also responsible for the analysis of patient (and animal) blood samples to evaluate the blood clearance and stability of the administered products. Patient sera samples are also analyzed to monitor the patient's immune response to the injected antibody constructs. Core B also performs the radiolabeling of all the antibodies, engineered antibodies, chemically modified antibodies and haptens for preclinical in vitro and in vivo use. Procedures involved in preparation of the radiopharmaceutical agents include chelate conjugate chemistry and conjugation as well as the antibody radiolabeling. As part of its core activity the Radiopharmacy also develops the monoclonal antibody construct conjugation methodologies for the clinical grade materials to be prepared in the cGMP facility for the Phase I trials. Core B will be associatedwith all three Projects as well as Cores A, C, D and E in this application.