The core consists of two components located at the Baylor Institute for Immunology Research (BUR) and the? Rockefeller University (RU). The primary objective of Cell Core will be to prepare DC vaccines from patients? with stage IV melanoma (Projects by Banchereau, Palucka, and Fay, BIIR) for the clinical trials proposed? in this Program Project. Three types of DC vaccine will be generated: i) DCs derived from CD34+? hematopoietic progenitors [CD34-DC] (Projects by Banchereau and Palucka)and ii) monocyte-derived DCs fMDCs] generated in cultures with GM-CSF and TNF (Projects by Banchereau and Fay). Tumor antigens will be loaded on vaccines in the form of i) peptides, ii) killed allogeneic melanoma cells, and iii) autologous myeloma cells. The estimated number of vaccines, based on the assumption that 75% of enrolled patients will qualify for full vaccination schedule, that will be prepared by the Core over the 5 years approaches approximately 1200 vaccines at BUR and approximately 400 vaccines at RU. Both Cores are operational and have already released substantial numbers of vaccines for clinical studies in healthy volunteers, patients with metastatic melanoma or with myeloma. The Core at BUR has thus far released >400 vaccines and the process has been successfully audited by the FDA. The Core will follow standard operating procedures that have been established at each institution for the generation of each type of DC. QA program is in place at both Institutions. Secondary objectives of Cell Core include: 1) development and? implementation of assays for potency assessment of DC vaccines, 2) development of closed system for DC? vaccine generation, and 3) development of cryopreserved vaccine and validation of its stability.
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