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

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA006973-54
Application #
9278341
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2017-05-01
Budget End
2018-04-30
Support Year
54
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
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