THERAPEUTIC MANUFACTURING

弗雷德·哈钦森癌症研究中心(FHCRC)和华盛顿大学(UW)为 一系列设施和合格的训练有素的人员，以支持小说的开发和制造 生物分子和基于细胞的创新疗法，用于I/I期临床试验。这些设施是 这是两家机构享誉世界的翻译研究工作不可或缺的一部分。为了支持这些努力， FHCRC和UW已将其三个良好制造规范(GMP)工厂合并为一个联合工厂 共同管理和运营的治疗制造单位。结合FHCRC生物制品的生产 和细胞处理设施(以前由这笔赠款支持)与UWS基因和细胞治疗核心 实验室已允许这两家机构进一步加强其在应用 用于治疗血液系统恶性肿瘤的免疫疗法，并将这项创新工作推广到其他 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 设施允许可重复生产大规模的生物试剂和治疗药物 在严格的质量控制和FDA要求的人体研究安全条件下的细胞。成功 这种材料的开发将对许多患者具有明显的意义。此外，在追求方面取得了进展 这些目标将与其他临床情况相关，教会我们关于 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治疗方法。此应用程序请求 继续支持在FRED中为研究发挥重要作用的资源 Hutchinson/华盛顿大学癌症联合会。

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.