The objectives of the Biomedicine Production Core (Applied Technology Core) are to facilitate the translational of bench-top research technologies into pilot-scale production and purification processes and to supply clinical biological material for use in human clinical trials. By providing these capabilities on campus, researchers are assured of complete oversight and control of the pre-clinical and clinical development of new therapeutic technologies and rapid movement of these technologies from the lab bench to the clinical setting.
The aims of this core are: 1) to complete process development of production and purification procedures for experimental technologies relating to viral and non-viral vector production, monoclonal antibody production and purification, Recombinant plasmid DNA production and hematopoietic cell engineering, 2) establish and maintain the necessary cell banks, plasmids DNA banks and helper viruses for use in product manufacturing, 3) establish in-house quality control systems to expedite product release, reduce overall contract assay costs and insure product safety, 4) manufacture suitable product material for Phase I and Phase II clinical trials, 5) develop and implement necessary document control, materials handling, personnel training and other support functions necessary to operate the facility in compliance with current Good Manufacturing Procedures. To achieve the above aims, a trained staff is being assembled with expertise in cGMP manufacturing of biologics, product development and regulatory affairs. The staff has significant collective expertise in the manufacture of viral and non-viral vectors, commercial production of monoclonal antibodies and manipulation of hematopoietic cells, including genetic engineering and expansion. Validation of the facility, processes and instrumentation is occurring throughout facility construction as outlined in an established Master Validation plan. Facility design and layout, and process, material and personnel flow through the facility have been reviewed by the teams from the Federal Food and Drug Administration and the California Food and Drug Branch. Process development is being performed in temporary facilities established in existing lab space in cooperation with individual Project Leaders and Directors. The Biomedicine Production Core will work with individual project leaders to provide regulatory assistance, develop production processes, generate supporting cell and DNA banks, perform all manufacturing and cell engineering and manage product release testing and represent the institution in interactions regarding manufacturing with the regulatory agencies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA030206-20
Application #
6492791
Study Section
Subcommittee E - Prevention &Control (NCI)
Project Start
2001-08-27
Project End
2002-03-31
Budget Start
Budget End
Support Year
20
Fiscal Year
2001
Total Cost
Indirect Cost
Name
City of Hope National Medical Center
Department
Type
DUNS #
City
Duarte
State
CA
Country
United States
Zip Code
91010
Limaye, Ajit P; La Rosa, Corinna; Longmate, Jeff et al. (2016) Plasma IL-10 Levels to Guide Antiviral Prophylaxis Prevention of Late-Onset Cytomegalovirus Disease, in High Risk Solid Kidney and Liver Transplant Recipients. Transplantation 100:210-6
Jonnalagadda, Mahesh; Mardiros, Armen; Urak, Ryan et al. (2015) Chimeric antigen receptors with mutated IgG4 Fc spacer avoid fc receptor binding and improve T cell persistence and antitumor efficacy. Mol Ther 23:757-68
Wang, Xiuli; Wong, ChingLam W; Urak, Ryan et al. (2015) CMVpp65 Vaccine Enhances the Antitumor Efficacy of Adoptively Transferred CD19-Redirected CMV-Specific T Cells. Clin Cancer Res 21:2993-3002
Mardiros, Armen; Forman, Stephen J; Budde, Lihua E (2015) T cells expressing CD123 chimeric antigen receptors for treatment of acute myeloid leukemia. Curr Opin Hematol 22:484-8
Caruso, Hillary G; Hurton, Lenka V; Najjar, Amer et al. (2015) Tuning Sensitivity of CAR to EGFR Density Limits Recognition of Normal Tissue While Maintaining Potent Antitumor Activity. Cancer Res 75:3505-18
Israyelyan, A; Goldstein, L; Tsai, W et al. (2015) Real-time assessment of relapse risk based on the WT1 marker in acute leukemia and myelodysplastic syndrome patients after hematopoietic cell transplantation. Bone Marrow Transplant 50:26-33
Wussow, Felix; Chiuppesi, Flavia; Martinez, Joy et al. (2014) Human cytomegalovirus vaccine based on the envelope gH/gL pentamer complex. PLoS Pathog 10:e1004524
Rushworth, David; Jena, Bipulendu; Olivares, Simon et al. (2014) Universal artificial antigen presenting cells to selectively propagate T cells expressing chimeric antigen receptor independent of specificity. J Immunother 37:204-13
Jena, Bipulendu; Moyes, Judy S; Huls, Helen et al. (2014) Driving CAR-based T-cell therapy to success. Curr Hematol Malig Rep 9:50-6
Singh, Harjeet; Huls, Helen; Kebriaei, Partow et al. (2014) A new approach to gene therapy using Sleeping Beauty to genetically modify clinical-grade T cells to target CD19. Immunol Rev 257:181-90

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