THERAPEUTIC MANUFACTURING

治疗性制造

• 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
• 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

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.

弗雷德哈钦森癌症研究中心（FHCRC）和华盛顿大学（UW）提供广泛的 一系列的设施和合格的训练有素的人员，以支持开发和生产的新的 生物分子和创新的基于细胞的疗法用于I/II期临床测试。这些设施是 这两个机构的世界著名的翻译研究工作的组成部分。为了支持这些努力， FHCRC和UW将其三个良好生产规范（GMP）设施合并为一个 共同管理和经营的治疗生产单位。结合FHCRC生物制品生产 和细胞处理设施（以前由该赠款支持）与UWs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 免疫疗法治疗血液恶性肿瘤，并将这一创新工作扩展到其他领域。 临床环境如自身免疫性疾病、黑素瘤、乳腺癌、卵巢癌和前列腺癌。这些 设施允许大规模的生物试剂和治疗剂的可再现生产， 细胞在严格的质量控制和安全条件下所要求的FDA人体研究。成功 这种材料的开发对许多患者具有明显的意义。此外，在追求进步 这些目标将与其他临床情况相关，为我们提供有关 疾病进展的分子基础，移植耐受的诱导，对感染性疾病的反应， 尤其是关于用于治疗癌症的免疫治疗方法。本申请要求 继续支持一个资源，它在弗雷德的研究中发挥着重要作用。 哈钦森/华盛顿大学癌症联盟。