THERAPEUTIC MANUFACTURING

治疗性制造

基本信息

批准号：
7944785
负责人：
LELAND H HARTWELL
金额：
$ 55.36万
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：
2009
资助国家：
美国
起止时间：
2009-03-10 至 2013-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7944785
关键词：
Address Antibodies Antigens Autoimmune Diseases Biochemical Biological Biological Assay Biological Products Biology Biotin Breast Melanoma Calibration Cancer Center Support Grant Cell Count Cell Culture System Cell Line Cell Maintenance Cell Therapy Cell physiology Cells Chemicals Classification Clinical Clinical Research Cloning Communicable Diseases Complex Cryopreservation Custom Cyclic GMP DNA Development Disease Progression Documentation Drug Formulations Educational process of instructing Endotoxins Ensure Environmental Monitoring Enzyme-Linked Immunosorbent Assay Equipment Equipment and supply inventories Flow Cytometry Fluorochrome Fred Hutchinson Cancer Research Center Genes Genetic Grant Guidelines Hematologic Neoplasms Human Human Resources Immunotherapy Infusion procedures Institution Investigation Investigational New Drug Application Laboratories Laboratory Research Leadership Maintenance Malignant Neoplasms Malignant neoplasm of prostate Manufactured Materials Methodology Methods Modification Molecular Monitor Mycoplasma Osmolalities Output Ovary Patients Peptides Pharmaceutical Preparations Phase Phenotype Pilot Projects Population Post-Translational Protein Processing Preparation Procedures Process Production Productivity Prokaryotic Cells Proteins Qualifying Quality Control Reagent Records Regulation Request for Applications Research Research Activity Research Infrastructure Research Personnel Resolution Resources Role Running Safety Serum-Free Culture Media Services Sodium Dodecyl Sulfate-PAGE Source Specific qualifier value Staging Standard Preparations Sterility Stream System Technical Expertise Testing Therapeutic Time Training Translational Research Transplantation Umbilical Cord Blood Universities Update Validation Washington Work analytical method base cancer therapy cell bank cell type clinical material cytokine innovation large scale production manufacturing facility meetings microbial novel pre-clinical pre-clinical research process optimization programs quality assurance research clinical testing response scale up validation studies

项目摘要

The Fred Hutchinson Cancer Research Center (FHCRC) and University of Washington (UW) offer a broad range of facilities and qualified trained personnel to support the development and manufacturing of novel biological molecules and innovative cell-based therapies for Phase I/I I clinical testing. These facilities are an integral part of the two institution's world-renowned translational research efforts. In support of these efforts, FHCRC and UW have consolidated their three Good Manufacturing Practice (GMP) facilities into one jointly co-administered and operated Therapeutic Manufacturing Unit. Combining the FHCRC Biologies Production and Cell Processing Facilities (previously supported by this grant) with the UWs Gene and Cell Therapy Core Laboratory has allowed these two institutions to further build on their leadership roles in the application of immunotherapy for the treatment of hematological malignancies, and to extend this innovative work to other clinical settings such as autoimmune disorders, melanoma, breast, ovary, and prostate cancer. These facilities permit the reproducible production of large-scale quantities of biological reagents and therapeutic cells under the strict quality control and safety conditions required by the FDA for human studies. Successful development of such materials will have obvious significance for many patients. Further, progress in pursuit of these aims will have relevance for other clinical situations, teaching us valuable lessons about the molecular basis for disease progression, induction of transplant tolerance, response to infectious diseases, and especially about immunotherapy approaches for the treatment of cancer. This application requests continued support for a resource which fulfills an essential role for research within the Fred Hutchinson/University of Washington Cancer Consortium.

Fred Hutchinson 癌症研究中心 (FHCRC) 和华盛顿大学 (UW) 提供广泛的研究一系列设施和训练有素的合格人员来支持新型药物的开发和制造用于 I/I I 期临床测试的生物分子和创新细胞疗法。这些设施是这是两个机构世界知名的转化研究工作的组成部分。为了支持这些努力， FHCRC 和 UW 联合将其三个良好生产规范 (GMP) 设施合并为一个共同管理和运营治疗制造部门。结合 FHCRC 生物制品生产和细胞处理设施（之前由该拨款支持）以及威斯康辛大学基因和细胞治疗核心实验室使这两个机构能够进一步发挥其在应用中的领导作用免疫疗法用于治疗血液恶性肿瘤，并将这项创新工作扩展到其他领域临床环境，如自身免疫性疾病、黑色素瘤、乳腺癌、卵巢癌和前列腺癌。这些设施允许大规模重复生产生物试剂和治疗剂细胞在 FDA 人体研究要求的严格质量控制和安全条件下进行。成功的开发此类材料对于许多患者来说将具有明显的意义。进一步追求进步这些目标中的一些将与其他临床情况相关，为我们提供宝贵的经验教训疾病进展的分子基础、移植耐受的诱导、对传染病的反应、尤其是关于治疗癌症的免疫疗法。本申请要求继续支持弗雷德研究中发挥重要作用的资源哈钦森/华盛顿大学癌症联盟。