Core B: Pharmaceutical Production

抽象-核心B CORE B负责生产临床级别的抗人CD45 BC8抗体(项目2和3)。 该抗体将与试剂(B10-NCS)偶联，用于用Asatine-211进行放射性标记。全 抗体和临床级试剂将在生物制品生产中生产、提纯和瓶装 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。临床分级 BC8-B10将在当前良好制造规范(CGMP)条件下生产，并将在一种药物 将编制主文件，并将其提交给食品和药物管理局。此外，核心B将 负责建立IND以支持进行第一阶段的人体临床试验。核心B 还将负责放射性标记抗犬ICOS的~(123)I和~(211)At 项目1的生物分布和治疗研究。将产生抗ICOS抗体本身 使用提供给项目%1的资源。

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.