Seminal gene-modified tumor cell-based clinical trials were initiated and have continued for nearly fifteen years at Johns Hopkins University (JHU). The Cell Processing and Gene Therapy Core (CPGT) was established in 2000 to manufacture clinical grade biotherapeutic material for Phase l/ll clinical gene therapy trials at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins. Oversight and resource utilization of the CPGT occurs under the direction of a dedicated Committee. The CPGT is composed of three components: a 400 square foot Process Optimization Lab (POL), a 400 square foot Materials Management/QC laboratory, and an 1800 square foot cGMP facility comprised of four manufacturing suites, a general processing area, storage, gown in and gown out areas. The POL is shared by the Cellular Therapy Core (CTC);all labs operate under shared management and oversight. This Core has been utilized by 17 faculty members who represent eleven Programs within the SKCCC. This facility supports the entire Johns Hopkins community in the translation of research concepts to human somatic cell and gene therapy clinical trials. The mission of the Core is to: 1) produce expanded cell-therapy and gene-therapy based biotherapeutic products for Phase I and II clinical studies employing current Good Manufacturing Practices (cGMP) as required by federal regulations, 2) manufacture novel biological oncolytic agents and clinical grade biotherapeutic reagents that require cGMP, as mandated by the FDA, 3) serve as a regulatory resource to the JHUSOM in the preparation of cell and gene-therapy based INDs, and 4) provide quality oversight, education and initiation of Good Laboratory Practices (GLP) in SKCCC Cores and laboratories. To date the CPGT Core has manufactured 32 different types of products including master cell banks, working cell banks, and clinical lots. This Core has been responsible for 14 SKCCC principal investigator sponsored Phase l/ll INDs supporting 24 clinical protocols with over 466 patients treated. This Core continues to facilitate clinical development of novel cancer therapies. Lay: The goal of the CPGT is to produce clinical grade biologic therapies for testing in early phase clinical trials that meet the regulatory conditions set forth by the United States FDA. These therapies are developed by SKCCC investigators and include vaccines, antibodies, peptides, and cancer targeting bacterial agents.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA006973-49
Application #
8559540
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-05-07
Project End
2017-04-30
Budget Start
2012-08-09
Budget End
2013-04-30
Support Year
49
Fiscal Year
2012
Total Cost
$419,512
Indirect Cost
$160,554
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Hurley, Paula J; Sundi, Debasish; Shinder, Brian et al. (2016) Germline Variants in Asporin Vary by Race, Modulate the Tumor Microenvironment, and Are Differentially Associated with Metastatic Prostate Cancer. Clin Cancer Res 22:448-58
Roberts, Nicholas J; Norris, Alexis L; Petersen, Gloria M et al. (2016) Whole Genome Sequencing Defines the Genetic Heterogeneity of Familial Pancreatic Cancer. Cancer Discov 6:166-75
Chen, Zhihang; Penet, Marie-France; Krishnamachary, Balaji et al. (2016) PSMA-specific theranostic nanoplex for combination of TRAIL gene and 5-FC prodrug therapy of prostate cancer. Biomaterials 80:57-67
Castanares, Mark A; Copeland, Ben T; Chowdhury, Wasim H et al. (2016) Characterization of a novel metastatic prostate cancer cell line of LNCaP origin. Prostate 76:215-25
Anders, Nicole M; Wanjiku, Teresia M; He, Ping et al. (2016) A robust and rapid liquid chromatography tandem mass spectrometric method for the quantitative analysis of 5-azacytidine. Biomed Chromatogr 30:494-6
Morgan, Michael T; Haj-Yahya, Mahmood; Ringel, Alison E et al. (2016) Structural basis for histone H2B deubiquitination by the SAGA DUB module. Science 351:725-8
Mao, Kai; Liu, Jieqiong; Sun, Jian et al. (2016) Patterns and prognostic value of lymph node dissection for resected perihilar cholangiocarcinoma. J Gastroenterol Hepatol 31:417-26
Morais, Carlos L; Guedes, Liana B; Hicks, Jessica et al. (2016) ERG and PTEN status of isolated high-grade PIN occurring in cystoprostatectomy specimens without invasive prostatic adenocarcinoma. Hum Pathol 55:117-25
Wang, Zhijun; Hansis, Eberhard; Chen, Rongxin et al. (2016) Automatic bone removal for 3D TACE planning with C-arm CBCT: Evaluation of technical feasibility. Minim Invasive Ther Allied Technol 25:162-70
Vrooman, Lynda M; Kirov, Ivan I; Dreyer, ZoAnn E et al. (2016) Activity and Toxicity of Intravenous Erwinia Asparaginase Following Allergy to E. coli-Derived Asparaginase in Children and Adolescents With Acute Lymphoblastic Leukemia. Pediatr Blood Cancer 63:228-33

Showing the most recent 10 out of 1943 publications