The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Cellular Therapy Core (CTC) consists of two facilities: 1) the clinical Cell Therapy Laboratory in the Harry and Jeanette Weinberg Building, and 2) the Process Optimization Laboratory, a designated facility in the Bunting Family and Jacob and Hilda Blaustein Family Cancer Research Building (CRBI) for translational scale-up studies. This Core supports investigator- sponsored clinical trials, including technology transfer from the research laboratory to the clinical setting, scale- up and validation studies. Laboratory staff members have extensive experience in all aspects of cellular therapy. This includes current Good Manufacturing Practice (cGMP) Phase I/II manufacturing for production of autologous/allogeneic products in which production volumes range from 1 to 10 liters, current Good Tissue Practice (cGTP) manufacturing of blood and bone marrow for transplantation, stem cell biology expertise, immunotherapy expertise, and clinical experience in transplantation and cellular therapies. There is extensive quality assurance (QA)/quality control (QC) and regulatory experience for the development of products and compliance with U.S. Food and Drug Administration (FDA) regulations. Core staff members also provide assistance in the preparation of regulatory documents, including Investigational New Drug (IND) applications. SKCCC Managed Core Reporting Period: Jan. 1, 2015, to Dec. 31, 2015
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