The mission of the Cell Therapies Core Facility (CTF) is to produce the highest quality cellular products in support of novel, investigator-initiated clinical trials that employ cell-based therapies. The core works directly with cancer center investigators to translate promising bench level research into clinical scale products, including assisting with the FDA's INID approval process. The activities of the facility include collection of the necessary patient cells and/or tissues, manufacturing of products derived from those cells and tissues for clinical use; and support of post treatment monitoring by facilitation of immunologic monitoring and other specialized testing necessary to address the scientific endpoints of each study. The facility comprises: (i) an apheresis suite for mononuclear cell collection from blood by apheresis; (ii) a production area for standard processing, such as gradient isolation of lymphocytes or large scale cell washing, and specialized cell product manufacturing determined by study design; (iii) a cryostorage laboratory to provide large and small-scale, long and short-term liquid nitrogen cryostorage of cellular products for eventual clinical application or laboratory analysis; and (iv) the Cell Therapies Analytic Laboratory for quality and safety testing of products and specialized testing of patient derived samples associated with CTF supported clinical studies. In support of its mission, the CTF is accredited by the Foundation for Accreditation of Cellular Therapy, and is accredited jointly with the Moffitt clinical laboratory by AABB and the College of American Pathologists, and is thus a CLIA certified facility. The CTF has grown in size and activity to support the efforts of 13 investigators receiving support from 11 federally funded projects. The CTF has supported 18 clinical studies, including four that have been conducted at multiple centers. Since the last review cycle, multiple new products and their associated manufacturing methodologies have also been implemented, validated, and put into service to support clinical trials. The Core requests CCSG Support of $225,711, which is 27% of its operational budget. Over 85% of usage is by Moffitt members and peer-reviewed.
The Cell Therapies Core is a valuable resource within Moffitt. Within this translational core is the wherewithal to translate laboratory scale concepts into clinical trial-ready products; to manufacture, release, and distribute those products according to applicable regulatory requirements; and to provide state-of-the-art immune monitoring support following administration of the test therapy. The core is at the heart of the process of bringing multiple products conceptualized by Moffitt members into clinical trials.
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