The rationale for the Clinical Cell and Vaccine Production Facility, Core B, is justified by the fact thatexperimental cell and gene therapy requires focused scientific, technical and regulatory expertise andresources that are not available to or fundable by individual researchers. The overall mission of the Core isto enable the translation from research bench to bedside of novel cellular and gene therapies. The firstelement in meeting the mission of the CVPF in supporting new clinical trials is the scale-up and validation oflarge-scale cell processing procedures. The CVPF was the first to develop a closed system method for theefficient large-scale culture of purified CD4+ T cells from HIV+ study subjects for a clinical trial initiated in1996. Since that time, the CVPF has developed clinical scale technology for the support of over 20 cell andgene therapy clinical trials in HIV and various cancers, including the world's first lentiviral vector clinical trial.The second aspect of the mission of the CVPF is to perform the cell processing of donor and patient cellsthat are to be reinfused to study subjects as investigational cellular vaccines. This includes performingrelease testing (Quality Control) that addresses the requirements for demonstrating safety, purity, potencyand identity of the cellular vaccines. All Quality Control testing and release is overseen by an externalQuality Assurance Officer. To date, the CVPF has produced 170 vaccines for over 100 people enrolled inthese trials. The CVPF will also serve as a cell and tissue repository, complying with HIPAA guidelines, insupport of the projects in this proposal. Finally, translation of research procedures for use in cell therapyclinical trials requires not only the use of clinical grade or clinically compatible reagents and materials, butalso a detailed knowledge of Good Manufacturing Practices and other regulations enforced by the FDA forall clinical trials. The CVPF staff provides Good Manufacturing Practice regulatory support for theinvestigators in this proposal to translate their discoveries at the bench to clinical trials and to supportongoing requirements of FDA annual report submission and FDA inquiries. The Core Director and staff haveworked closely with many of the Pi's of the various projects and coordination of the Core in support of eachproject as described in the various sections will be seamless.
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