Seminal gene-modified tumor cell-based clinical trials were initiated and have continued for nearly a decade at Johns Hopkins University (JHU). These clinical studies were based upon NIH-funded Principal Investigators'discovery and development of basic research concepts, with various commercial entities manufacturing and releasing the clinical products. The Cell Processing and Gene Therapy Core (CPGT) was established in 2000 to manufacture clinical grade biotherapeutic material for Phase l/ll clinical gene therapy trials at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins. Oversight and resource utilization of the Cell Processing and Gene Therapy Core occurs under the direction of a dedicated committee. The Cell Processing and Gene Therapy Core is composed of two components: a 400 square foot Process Optimization Lab (POL) and an 1800 square foot cGMP facility comprised of 4 manufacturing suites, a general processing area, storage, gown in and gown out areas. The Process optimization lab is shared by the Cellular] Therapy Core and all three labs operate under shared management and oversight. This Core has been utilized by 15 faculty members who represent 9 programs within the SKCCC. This facility supports the entire Johns Hopkins community in the translation of research concepts to human somatic cell and gene therapy clinical trials. The mission of the Core is to: 1) produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies. Production employs current Good Manufacturing Practices (cGMP) as required by federal regulations. 2) manufacture novel biological oncolytic agents and clinical grade biotherapeutic] reagents that require cGMP, as mandated by the FDA 3) serve as a regulatory resource to the SKCCC membership in the preparation of cell and gene- therapy based INDs. To date the Cell Processing and Gene Therapy Core has manufactured 10 different types of products. This Core will continue facilitating clinical development of novel cancer therapies.
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