GMP Manufacturing

摘要 十多年前，希望之城(COH)认识到需要建立必要的基础设施，以便 研究人员通过Pre-Pre-Rate高效开发新兴的细胞和基因治疗创新 临床和临床研究。为了实现这一目标，COH创建了生物和细胞GMP制造 共享资源和Ind发展和监管事务办公室以及当前的两项成果 符合生产规范(CGMP)的生物制品制造设施，生物医学和 遗传学(CBG)和细胞治疗生产中心(CTPC)。最近，COH扩大了这一领域 翻译基础设施通过创建一个独立的符合cGMP的小分子制造设施 化学GMP合成设施(CGSF)。独立管理的质量体系小组提供质量保证 监督所有制造和产品质量控制活动，并负责监管 COH生产的所有cGMP产品的合规性和产品放行。COH创立了生物圈 而元胞GMP制造共享资源和CGSF不仅是COH的便利资源 研究人员，以及区域和国家资源，以促进新思想的快速翻译，这些新思想可以 造福全国各地的患者。拥有超过16年的运营经验和超过60名员工， 生物和细胞GMP制造共享资源和CGSF提供了300多个释放批次 向COH和全国各地的40多名研究人员提供细胞疗法、生物制剂和小分子的 欧洲。核心D的主要目标是提供流程开发、监管支持和良好的 符合cGMP的临床级特征性克隆CAR T细胞产品的有文件记录的生产 抗体、慢病毒载体和复杂的小分子，包括纳米材料、生物聚合物 (多肽、siRNA-适配子和DNA-多肽杂合体)和复杂的天然产物。我们将应用我们的 建立项目管理、产品开发、监管和制造能力，使其受益 通过在临床前发展战略、监管事务、 和过程的下放。质量保证、产品特性和合规性 从cGMP临床生产的广泛历史中获得的工艺和产品要求 试验将确保拟议的临床项目的适宜性、可控性和可扩展性。

SUMMARY Over a decade ago, City of Hope (COH) recognized the need to establish the infrastructure necessary to allow researchers to efficiently and effectively develop emerging cell and gene therapeutic innovations through pre- clinical and clinical studies. To achieve this goal, COH created the Biological and Cellular GMP Manufacturing Shared Resource and the Office of IND Development and Regulatory Affairs and two current Good Manufacturing Practice (cGMP)-compliant biologics manufacturing facilities, the Center for Biomedicine and Genetics (CBG) and the Cell Therapy Production Center (CTPC). More recently, COH expanded this translational infrastructure by creating a separate small molecule cGMP-compliant manufacturing facility, the Chemical GMP Synthesis Facility (CGSF). An independently managed Quality Systems group provides QA oversight to all manufacturing and product Quality Control activities and is responsible for regulatory compliance and product release of all cGMP products manufactured at COH. COH established the Biological and Cellular GMP Manufacturing Shared Resource and the CGSF to be not only facilitating resources for COH researchers, but also regional and national resources to facilitate the rapid translation of new ideas that could benefit patients across the nation. With over 16 years of operation and a combined staff of over 60, the Biological and Cellular GMP Manufacturing Shared Resource and CGSF have provided over 300 released lots of cell therapies, biologics, and small molecules to over 40 investigators at COH and across the country and Europe. The primary objective of Core D is to provide process development, regulatory support, and well- documented cGMP-compliant clinical-grade production of characterized CAR T cell products, monoclonal antibodies (mAb), lentivirus vectors, and complex small molecules, including nanomaterials, biopolymers (peptides, siRNA-aptamers, and DNA-peptide hybrids), and complex natural products. We will apply our established project management, product development, regulatory, and manufacturing capability to the benefit of COH SPORE investigators by providing assistance in pre-clinical development strategy, regulatory affairs, and process devolvement. Quality Assurance, product characterization, and compliance with regulatory requirements for process and product gained from our extensive history of cGMP manufacturing for clinical trials will ensure suitability, control, and scalability of the proposed clinical projects.