Core B: Pharmaceutical Production

核心B：药品生产

• 批准号: 8742468
• 负责人: JOHN M PAGEL
• 金额: $ 32.23万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-03-31 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8742468
• 关键词: Address; Allografting; Alpha Particles; Antibodies; Astatine; Biodistribution; Bismuth; Canis familiaris; Cells; Chimerism; Clinical; Clinical Research; Clinical Trials; Cyclotrons; Discipline of Nuclear Medicine; Disease; Evaluation; Fred Hutchinson Cancer Research Center; Funding; Hematopoietic; Human; Image; Investigational New Drug Application; Label; Laboratories; Malignant - descriptor; Metals; Monoclonal Antibodies; PTPRC gene; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Positron; Preparation; Production; Program Research Project Grants; Radiochemistry; Radioimmunotherapy; Radioisotopes; Radiolabeled; Reaction; Reagent; Regimen; Research; Resource Sharing; Resources; Stem cells; Treatment Protocols; United States Food and Drug Administration; Universities; Washington; antibody conjugate; dosimetry; hematopoietic cell transplantation; irradiation; multidisciplinary; novel; pre-clinical; preclinical study; public health relevance; radiotracer

ABSTRACT - CORE B Core B is responsible for the production of clinical grade anti-human CD45 BC8 antibody (Projects 2 and 3). The antibody will be conjugated with a reagent (B10-NCS) for radiolabeling with astatine-211. All antibodies and clinical grade reagents will be produced, purified and vialed in the Biologics Production Facility of the Fred Hutchinson Cancer Research Center. Pre-clinical and clinical radiolabeling reactions will be conducted in appropriate radiochemistry laboratories at the University of Washington. Clinical grade BC8-B10 will be produced under current good manufacturing practice (cGMP) conditions and a Drug Master File will be developed and submitted to the Food and Drug Administration. In addition, Core B will be responsible for the establishment of an IND to support conduct of Phase I human clinical trials. Core B will also be responsible for radiolabeling anti-canine ICOS with 123I and 211At which are required for biodistribution and therapy studies respectively for Project 1. The anti-ICOS antibody itself will be produced using resources supplied to Project 1.

摘要 - 核心 B Core B负责生产临床级抗人CD45 BC8抗体（项目2和3）。 该抗体将与试剂 (B10-NCS) 结合，用于用砹-211 进行放射性标记。全部 抗体和临床级试剂将在生物制剂生产中生产、纯化和装瓶 弗雷德·哈钦森癌症研究中心的设施。临床前和临床放射性标记反应 将在华盛顿大学适当的放射化学实验室进行。临床等级 BC8-B10 将在当前良好生产规范 (cGMP) 条件下和药物 将制定主文件并提交给食品和药物管理局。此外，核心B将 负责建立IND以支持开展I期人体临床试验。核心B 还将负责用 123I 和 211At 进行放射性标记抗犬 ICOS，这是 项目1分别进行生物分布和治疗研究。抗ICOS抗体本身将被生产 使用提供给项目 1 的资源。