GMP Manufacturing

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Abstract Shared Resource 05: GMP Manufacturing (GMP-SR) The GMP Manufacturing Shared Resource (GMP-SR) at City of Hope (COH) offers both biological and chemical GMP manufacturing capabilities allowing for rapid and cost-effective translation of novel therapeutic agents to clinical trials. Together, the biological and chemical GMP facilities are unique to COH and have distinguished it as one of the premier cancer institutions in the nation for translating innovative therapies developed by COH investigators over the past decade. Specific Aims for GMP-SR: Aim 1. Production of viral vectors. Aim 2. Production of autologous CAR T cell products, CD34+ HSPC gene therapy, and TIL cell products. Aim 3. Production of allogeneic cell therapy products for Phase 1 clinical trials. Aim 4. Manufacturing of small molecule therapeutics. The GMP-SR consists of two biological facilities, the Center for Biomedicine & Genetics (CBG), the Cell Therapy Production Center (CTPC), and a Chemical GMP Synthesis Facility (CGSF). These resources provide process development, project management support, budgeting, regulatory strategy, quality control and quality assurance, and cGMP-compliant clinical-grade production of immune effector cell products, stem cell-based regenerative medicine products, monoclonal antibodies, lentivirus, retrovirus, poxvirus, herpes simplex virus, and adenovirus vectors, vaccines, as well as small molecule agents ranging from low molecular weight molecularly targeted agents (mw <1000) to complex synthetic biopolymers such as RNA-based oligonucleotide therapeutics and imaging agents. The CBG and CTPC are fully cGMP-compliant preclinical and Phase 1/2 pilot manufacturing facilities. In addition to being multi-product capable, CBG is the nation’s pre-eminent multi-process academic facility capable of simultaneously producing cGMP-compliant clinical-grade products for preclinical studies and early-stage clinical trials. These two biological facilities support production of viral vectors and modified cell products in Phase 1 clinical trials. Currently, COH investigators manufacture CAR T cells, CAR Treg cells, NK cells, dendritic cells, CD34+ hematopoietic stem/progenitor cells, and islet cells. The CGSF manufactures small and large molecule therapeutics including drugs and biopolymers. Members Utilization by %Revenue 2017–21: 98.6 Total (1.5 MCBC, 5.8 DCT, 54 CI, 37.3 HM, 0 CCPS) Publications by Members: 8, 4 with Impact Factor >10 Grants Supported: 6 Total (3 CIRM, 3NCI (2R01))