CLINICAL BIOLOGICS MANUFACTURING AND CELL CULTURE (CBMCC) SHARED RESOURCE Timothy Clay, Ph.D., Director The Cancer Center Clinical Biologics Manufacturing and Cell Culture (CBMCC) Shared Resource combines hree elements: (i) the Clinical Biologics Manufacturing Unit for manufacturing under cGMP cellular, tissue, _rotein, antibody, nucleic acid, and viral vector modified biologics for testing in early phase clinical trials; (ii) ihe Non-clinical Cell Culture Unit which is a specialized cell culture service that includes a cell line repository and large scale cell culture capacity for Cancer Center investigators; and (iii) the Supply Unit, a self-supporting reagent supply service for research laboratories within the Cancer Center and campus-wide. The Clinical Biologics Manufacturing Unit is a new addition to this shared resource since the previous review in 1998. By adding this new component to this shared resource, we have greatly increased the scientific merit of the shared resource and established a critical element within the Cancer Center for translating novel therapies from the research bench to early phase clinical trials. The Unit provides a skilled staff with extensive technica!, expertise in clinical biologics manufacturing under strictly regulated, FDA approved protocols and SOP s, who can perform manufacturing for Cancer Center members. Additionally, regulatory submission s to the IRB, FDA, CTEP, and NIH-RAC, and regulatory oversight of manufacturing is also supported within this Unit. The non-clinical Cell Culture Unit provides technical support for the Cancer Center members. In 2003 the Unit provided services to 97 peer-reviewed Cancer Center members in all 11 Cancer Center Programs. Many Cancer Center members rely on this Unit to perform small and large-scale cell culture because they lack the personnel, expertise, or the equipment to perform this task in their own labs. The Supply Unit provides material support for CMBCC technical efforts and for the Cancer Center member's own labs. Its large user base allows it to negotiate excellent price contracts (75% discounts) and pass these savings directly on to Cancer Center members.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA014236-34
Application #
7726668
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2008-01-01
Budget End
2008-12-31
Support Year
34
Fiscal Year
2008
Total Cost
$126,471
Indirect Cost
Name
Duke University
Department
Type
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Xu, Yinghui; Wang, Yanru; Liu, Hongliang et al. (2018) Genetic variants in the metzincin metallopeptidase family genes predict melanoma survival. Mol Carcinog 57:22-31
Abdi, Khadar; Kuo, Chay T (2018) Laminating the mammalian cortex during development: cell polarity protein function and Hippo signaling. Genes Dev 32:740-741
Lu, Min; Sanderson, Sydney M; Zessin, Amelia et al. (2018) Exercise inhibits tumor growth and central carbon metabolism in patient-derived xenograft models of colorectal cancer. Cancer Metab 6:14
Qian, Danwen; Liu, Hongliang; Wang, Xiaomeng et al. (2018) Potentially functional genetic variants in the complement-related immunity gene-set are associated with non-small cell lung cancer survival. Int J Cancer :
Ashcraft, Kathleen A; Choudhury, Kingshuk Roy; Birer, Sam R et al. (2018) Application of a Novel Murine Ear Vein Model to Evaluate the Effects of a Vascular Radioprotectant on Radiation-Induced Vascular Permeability and Leukocyte Adhesion. Radiat Res 190:12-21
Ong, Cecilia T; Campbell, Brittany M; Thomas, Samantha M et al. (2018) Metaplastic Breast Cancer Treatment and Outcomes in 2500 Patients: A Retrospective Analysis of a National Oncology Database. Ann Surg Oncol 25:2249-2260
Duan, Bensong; Hu, Jiangfeng; Liu, Hongliang et al. (2018) Genetic variants in the platelet-derived growth factor subunit B gene associated with pancreatic cancer risk. Int J Cancer 142:1322-1331
Wu, Mengxi; Huang, Po-Hsun; Zhang, Rui et al. (2018) Circulating Tumor Cell Phenotyping via High-Throughput Acoustic Separation. Small 14:e1801131
Vlahovic, Gordana; Meadows, Kellen L; Hatch, Ace J et al. (2018) A Phase I Trial of the IGF-1R Antibody Ganitumab (AMG 479) in Combination with Everolimus (RAD001) and Panitumumab in Patients with Advanced Cancer. Oncologist 23:782-790
Xu, Yinghui; Liu, Hongliang; Liu, Shun et al. (2018) Genetic variant of IRAK2 in the toll-like receptor signaling pathway and survival of non-small cell lung cancer. Int J Cancer 143:2400-2408

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