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Core B: Pharmaceutical Production

核心B：药品生产

基本信息

批准号：
10025204
负责人：
BRENDA MARIE SANDMAIER
金额：
$ 49.05万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
起止时间：
1999-04-12 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10025204
关键词：
Acute leukemia Allogenic Allografting Antibody Formation Astatine Biological Biological Assay Biometry Blood Bone Marrow Calibration Clinical Clinical Research Clinical Trials Conduct Clinical Trials Cyclotrons Data Analyses Development Disease Drug Kinetics Dysmyelopoietic Syndromes Equipment Fred Hutchinson Cancer Research Center Graft-Versus-Tumor Induction Human Human Resources Individual Infrastructure Label Laboratories Laboratory Chemicals Lead Location Malignant - descriptor Malignant Neoplasms Materials Testing Medical Methods Monoclonal Antibodies Multiple Myeloma PTPRC gene Patients Pharmaceutical Preparations Pharmacologic Substance Plasma Cells Procedures Process Product Labeling Production Program Research Project Grants Quality Control Radiochemistry Radioimmunoconjugate Radioimmunotherapy Radioisotopes Radiolabeled Reagent Regimen Regulation Relapse Research Research Personnel Resource Sharing Resources Running Sampling Services Site Stem cell transplant Sterility Technical Expertise Techniques Testing Therapeutic Time Treatment Protocols Universities Vial device Washington antibody conjugate base data management hematopoietic cell transplantation monoclonal antibody production novel preclinical study prevent research clinical testing sample collection scale up translational scientist

项目摘要

PROJECT SUMMARY / ABSTRACT – CORE B Core B, Pharmaceutical Production, is responsible for the production of the monoclonal antibodies (MAbs), the antibody conjugates, the alpha-emitting radionuclide astatine-211 (211At) and the 211At-labeled antibody conjugates. The Core will produce anti-CD45 and anti-CD38 MAbs used in preclinical studies (Projects 1, 2 and 3) and produce clinical grade anti-human CD45 BC8 MAb and anti-human CD38 OKT10 MAb used in clinical trials (Projects 2 and 3). The MAbs will be conjugated with a novel reagent (B10-NCS) to produce MAb-B10 conjugates for radiolabeling with astatine-211 (211At). All MAbs and clinical grade reagents will be produced, purified and vialed in the Biologics Production Facility (BPF) of the Fred Hutch. The B10-NCS reagent and MAb-B10 conjugates used for preclinical studies will be produced in appropriate chemical laboratories at the University of Washington. Clinical grade BC8-B10 conjugate and OKT10-B10 will be produced, purified and vialed under current good manufacturing practice (cGMP) conditions in the Fred Hutch BPF. Production, isolation and purification of the 211At will be done in the UW Medical Cyclotron Facility and UW Radionuclide Production Laboratory. The 211At-MAb-B10 for preclinical studies will be conducted in UW radiochemistry laboratory, and 211At-BC8-B10 and 211At-OKT10-B10 used in the clinical trials will be produced in a cGMP facility at UW. Testing of the materials produced will be conducted at UW or Fred Hutch, depending on the assay. Patient samples obtained from Projects 2 and 3 will be collected, processed and stored at the Fred Hutch for use in Project 1.

项目摘要/摘要 – 核心 B 核心 B，药品生产，负责单克隆抗体 (MAb) 的生产，抗体偶联物、α发射放射性核素砹-211 (211At) 和 211At 标记抗体共轭物。核心将生产用于临床前研究的抗 CD45 和抗 CD38 单克隆抗体（项目 1、2 3) 生产临床级抗人CD45 BC8 MAb和抗人CD38 OKT10 MAb，用于临床试验（项目 2 和 3）。 MAb 将与新型试剂 (B10-NCS) 结合以产生 MAb-B10 缀合物用于用砹-211 (211At) 进行放射性标记。所有单克隆抗体和临床级试剂都将在 Fred Hutch 的生物制剂生产设施 (BPF) 中生产、纯化和装瓶。 B10-NCS 用于临床前研究的试剂和 MAb-B10 缀合物将在适当的化学物质中生产华盛顿大学的实验室。临床级 BC8-B10 结合物和 OKT10-B10 将在 Fred Hutch 现行良好生产规范 (cGMP) 条件下生产、纯化和装瓶 BPF。 211At 的生产、分离和纯化将在华盛顿大学医学回旋加速器设施中完成华盛顿大学放射性核素生产实验室。用于临床前研究的211At-MAb-B10将在华盛顿大学进行放射化学实验室，生产用于临床试验的211At-BC8-B10和211At-OKT10-B10 在华盛顿大学的 cGMP 设施中。所生产材料的测试将在华盛顿大学或 Fred Hutch 进行，具体取决于化验上。从项目 2 和 3 获得的患者样本将被收集、处理并储存在 Fred Hutch 用于项目 1。