Cell Processing and Vector Production

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PROJECT SUMMARY: Cell Processing and Vector Production (CPVP) Shared Resource The Cell Processing and Vector Production (CPVP) Shared Resource provides manufacturing of therapeutic grade cellular therapy products and viral vector for use in early phase clinical trials. These must be prepared according to current Good Manufacturing Practices (GMP) as mandated by the Food and Drug Administration. This Shared Resource provides the infrastructure and environment to prepare, test, and release these products for use. It consists of a state-of-the-art facility with 22 manufacturing clean rooms and support facilities (quality control and flow cytometry laboratories, material management facilities etc.), and highly experienced manufacturing and quality control and assurance staff. This DLDCCC Resource will work with investigators to develop clinical scale manufacturing procedures, and release test specifications, testing procedures, quality assurance oversight, and regulatory assistance to assist in IND submissions. The resource has, therefore, facilitated the transition of cellular and gene therapy products from the basic science laboratories in the DLDCCC into early-phase clinical trials. The CPVP currently supports more than 50 clinical trials (21 actively accruing, 18 in follow-up, and 11 in stages of translation to investigational new drug applications [INDs]) held by DLDCCC investigators and does so at a much-reduced cost compared to commercial manufacturing and testing entities.