Seminal gene-modified tumor cell-based clinical trials were initiated and have continued for nearly fifteen years at Johns Hopkins University (JHU). 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 CPGT occurs under the direction of a dedicated Committee. The CPGT is composed of three components: a 400 square foot Process Optimization Lab (POL), a 400 square foot Materials Management/QC laboratory, and an 1800 square foot cGMP facility comprised of four manufacturing suites, a general processing area, storage, gown in and gown out areas. The POL is shared by the Cellular Therapy Core (CTC);all labs operate under shared management and oversight. This Core has been utilized by 17 faculty members who represent eleven 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 employing 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 JHUSOM in the preparation of cell and gene-therapy based INDs, and 4) provide quality oversight, education and initiation of Good Laboratory Practices (GLP) in SKCCC Cores and laboratories. To date the CPGT Core has manufactured 32 different types of products including master cell banks, working cell banks, and clinical lots. This Core has been responsible for 14 SKCCC principal investigator sponsored Phase l/ll INDs supporting 24 clinical protocols with over 466 patients treated. This Core continues to facilitate clinical development of novel cancer therapies. Lay: The goal of the CPGT is to produce clinical grade biologic therapies for testing in early phase clinical trials that meet the regulatory conditions set forth by the United States FDA. These therapies are developed by SKCCC investigators and include vaccines, antibodies, peptides, and cancer targeting bacterial agents.
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