The vector core provides clinical investigators with services relating to generation, manufacturing and validation of clinical grade vectors and also validation of transduced cells for clinical trials. The core provides the vectors being used for modification of human autologous cytotoxic T cells for the clinical trials described in project 1 and the vectors containing HIV intracellular vaccines constructs for the clinical trial in project 2. All vectors are produced in accordance with good laboratory practices (GLP) and good manufacturing practices (GMP) consistent with FDA requirements. In addition to manufacturing clinical grade vectors, the vector core is responsible for regulatory filings with the FDA relating to manufacturing and clinical use of these vectors. The vector core also assists investigators with obtaining regulatory approval for the clinical trials described in Projects 1 and 2.
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