GMP Manufacturing Core Shared Resource ABSTRACT The GMP Manufacturing Core Facility at City of Hope offers both biological and chemical GMP manufacturing capabilities. The biological facilities consist of the Biologics & Cellular GMP Manufacturing Center, comprising the Center for Biomedicine and Genetics (CBG) and the Cell Therapy Production Center (CTPC). The Chemical GMP Synthesis Facility (CGSF) is a stand-alone operation providing state-of-the-art biopolymer and small molecule manufacturing. COH is the only Cancer Center in the US to provide both biological and chemical GMP manufacturing at a single institution. These facilities provide process development, regulatory support, and cGMP-compliant clinical-grade production of CAR T cell products, stem cell-based regenerative medicine products, monoclonal antibodies, lentiviral vectors, vaccines, and complex molecules including, biopolymers (peptides, siRNA-aptamers, DNA-peptide hybrids), nanomaterials, and natural products. Opened in 2000, the CBG is a fully cGMP-compliant 20,000 square foot preclinical and Phase I/II pilot manufacturing facility with 10,000 square feet of classified production space. In addition to being multi-product capable, it is the nation?s pre-eminent multi-process academic facility capable of simultaneously producing cGMP-compliant clinical-grade products in sufficient quantities for preclinical studies and early stage clinical trials. The CBG supports COH investigators in the production of viral vectors and modified cell products (CAR T cells; gene-modified CD34+ cells; gene-modified neural stem cells) that are currently in Phase I clinical trials for indications including CD19+ malignancies, AML, GBM, and AIDs-related lymphoma. The CTPC is also cGMP-compliant and opened in 2010 to meet additional demand for cell therapeutics. The CTPC provides 6,800 sq. ft. of production space and is capable of simultaneous multi-product and multi-process manufacturing. The state-of-the-art CGSF (established in 2012) manufactures small and large molecule therapeutics. It also produces nanomaterials, complex natural products, and biopolymers, such as peptides, siRNA-aptamers, DNA- peptide hybrids. The CGSF provides services including: drug discovery, process research, development, and early clinical manufacturing of pharmaceutical drug substances (APIs). The facility is designed with three independent manufacturing suites to produce API that meets Food and Drug Administration requirements and on sufficient scales (gram to kilogram) for preclinical toxicology studies and Phase I/II clinical trials. The GMP Manufacturing Core is co-directed by Joseph Gold, PhD, David Horne, PhD, and Dr. David Hsu. Over the past five years, the Core was used by a total of 28 unique investigators, including ten CC members and eight NCI-designated Cancer Centers. In addition, 553 products were manufactured and 7 separate cancer clinical trials were supported by the Core.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA033572-37
Application #
9849203
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2019-12-01
Budget End
2020-11-30
Support Year
37
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Beckman Research Institute/City of Hope
Department
Type
DUNS #
027176833
City
Duarte
State
CA
Country
United States
Zip Code
91010
Slavin, Thomas P; Banks, Kimberly C; Chudova, Darya et al. (2018) Identification of Incidental Germline Mutations in Patients With Advanced Solid Tumors Who Underwent Cell-Free Circulating Tumor DNA Sequencing. J Clin Oncol :JCO1800328
Yun, Xinwei; Zhang, Keqiang; Wang, Jinhui et al. (2018) Targeting USP22 Suppresses Tumorigenicity and Enhances Cisplatin Sensitivity Through ALDH1A3 Downregulation in Cancer-Initiating Cells from Lung Adenocarcinoma. Mol Cancer Res 16:1161-1171
Herrera, Alex F; Rodig, Scott J; Song, Joo Y et al. (2018) Outcomes after Allogeneic Stem Cell Transplantation in Patients with Double-Hit and Double-Expressor Lymphoma. Biol Blood Marrow Transplant 24:514-520
Oh, Eunjin; Ahn, Miwon; Afelik, Solomon et al. (2018) Syntaxin 4 Expression in Pancreatic ?-Cells Promotes Islet Function and Protects Functional ?-Cell Mass. Diabetes 67:2626-2639
Shahin, Sophia A; Wang, Ruining; Simargi, Shirleen I et al. (2018) Hyaluronic acid conjugated nanoparticle delivery of siRNA against TWIST reduces tumor burden and enhances sensitivity to cisplatin in ovarian cancer. Nanomedicine 14:1381-1394
Wittenberg, Elaine; Ferrell, Betty; Koczywas, Marianna et al. (2018) Pilot Study of a Communication Coaching Telephone Intervention for Lung Cancer Caregivers. Cancer Nurs 41:506-512
Zhang, Keqiang; Wang, Jinhui; Yang, Lu et al. (2018) Targeting histone methyltransferase G9a inhibits growth and Wnt signaling pathway by epigenetically regulating HP1? and APC2 gene expression in non-small cell lung cancer. Mol Cancer 17:153
Zhang, Bin; Nguyen, Le Xuan Truong; Li, Ling et al. (2018) Bone marrow niche trafficking of miR-126 controls the self-renewal of leukemia stem cells in chronic myelogenous leukemia. Nat Med 24:450-462
Kirschbaum, Mark H; Frankel, Paul; Synold, Timothy W et al. (2018) A phase II study of vascular endothelial growth factor trap (Aflibercept, NSC 724770) in patients with myelodysplastic syndrome: a California Cancer Consortium Study. Br J Haematol 180:445-448
Liu, Liang; Yang, Lin; Yan, Wei et al. (2018) Chemotherapy Induces Breast Cancer Stemness in Association with Dysregulated Monocytosis. Clin Cancer Res 24:2370-2382

Showing the most recent 10 out of 1396 publications