The mission of the Cell Manipulation Core is to produce safe and effective cellular components for patients enrolled in novel therapeutic clinical research protocols. In this context, the Core supports primarily translational research and works closely with many laboratory investigators in the Cancer Immunology Program as well as with clinical investigators in disease-focused Programs within DF/HCC. These DF/HCC investigators work in diverse areas including hematopoietic stem cell transplantation, cancer vaccines, and adoptive cellular therapy of cancer. All procedures are performed according to current Good Manufacturing Practices (cGMPs) for cell and tissue processing. Regulations and standards have been developed by the FDA's Center for Biologics Evaluation and Research (CBER), the American Association of Blood Banks (AABB), and the Foundation for the Accreditation of Cellular Therapy (FACT). The policies and procedures established in the facility comply with these standards and regulations, ensuring the production of safe, effective components for clinical use. Cellular products processed by the Core are provided in the context of clinical research protocols that have been reviewed and approved by the DF/HCC Scientific Review Committee and Institutional Review Board. Together with adherence to cGMPs, the requirement that extensive cell processing is only provided for patients enrolled on approved clinical research protocols ensures that this core facility provides a unique service to DF/HCC Research Programs and Members.
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