GMP Manufacturing

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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.