Therapeutic Manufacturing Shared Resource Project Summary/Abstract The Therapeutic Manufacturing Shared Resource (TMSR) offers a broad range of facilities and qualified trained personnel to support the development and manufacturing of novel biological molecules and innovative cell-based therapies for Phase I/II clinical testing. These facilities are an integral part of the Consortium's world-renowned translational research efforts. To enhance these endeavors, the resource has consolidated two Good Manufacturing Practice (GMP) facilities into one jointly co-administered and operated Therapeutic Manufacturing Shared Resource. Combining the Biologics Production and Cell Processing Facilities (previously supported by this grant) has allowed the Consortium to further build on their leadership role in the application of immunotherapy for the treatment of hematological malignancies, and to extend this innovative work to other clinical settings such as autoimmune disorders, melanoma, sarcoma, breast, ovary, and prostate cancers. Formation of this combined unit greatly enhances efficiencies of operation, thus providing more Consortium investigators with greater access to a wider range of therapeutic products. GMP manufacturing capabilities include specialized equipment and trained staffing necessary for supporting clinical studies that incorporate specific cell selection, genetic modification and/or ex vivo manipulation of patient stem cells, dendritic cells and T-cells, as well as the production of research and clinical grade monoclonal antibodies, antibody-streptavidin fusion proteins, vaccines, lentivirus vectors and other therapeutic molecules. The facilities assist investigators at the University of Washington (UW), Fred Hutchinson Cancer Research Center (FHCRC), Seattle Cancer Care Alliance (SCCA), and Seattle Children's Hospital (Children's) in their pre-clinical research efforts, pilot production requirements, clinical trial design, and other support activities needed for filing of both Investigational New Drug (IND) Applications and Drug Master Files (DMF), and finally for clinical manufacturing activities once IND approval has been received, all while providing appropriate levels of quality control, quality assurance, and regulatory oversight to ensure compliance with strict FDA requirements.
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