The Center for Cell and Gene Therapy (CAGT) at BCM has considerable expertise in all aspects of adenoviral vector technology, from design of vector constructs, through current Good Manufacturing Practices (cGMP), to clinical applications, and associated quality assurance/control and regulatory issues. The Vector Production Laboratory (VPL) has manufactured 91 lots of research grade adenoviral vector and 21 lots of clinical grade vectors encoding seven gene products. It has provided vectors for 19 gene therapy Investigational New Drug (IND) studies at BCM alone, and has recently scaled-up operations to increase production capacity, that would allow it to produce 12-15 lots/year for NGVL investigators. The 1600 square foot facility is well equipped and consists of two Class 10,000 adenoviral production suites that operate in compliance with cGMP. In Q3 2001 the facility will be renovated to provide five production suites designed to full GMP standards with clean and dirty access corridors. Support services for the facility include a GMP shipping and receiving area with bar coding systems and quarantine areas, an integral, but independent Quality Assurance and Control Laboratory for product testing and release, environmental monitoring and quality improvement, and a 6,000 square feet GMP cell processing facility that includes a GMP restricted-access clinical product storage area for management of product inventories. These facilities operate according to Standard Operating Procedures (SOPs) and have developed a number of computer software systems to facilitate GMP compliance. Through the Center, NGVL investigators will also have access to a number of ancillary services. These include: 1) the VPL, which has considerable experience in the construction and production of various generations of adenoviral vectors; 2) the Non-Viral Vector Laboratory which has pioneered the use of liposomes for the delivery of genetic material; 3) the Helper Dependent Adenoviral Vector Laboratory directed by Dr. Arthur Beaudet; and 4) the Protocol Research and Regulatory Affairs Office, which can provide assistance with IND applications, monitoring and reporting, auditing and biostatistics. This unique combination of resources, combined with the long experience of the VPF in manufacturing clinical grade material, would prove a valuable addition to the capabilities of the NGVL.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements (U42)
Project #
5U42RR016578-03
Application #
6619550
Study Section
Special Emphasis Panel (ZRR1-CR-4 (01))
Program Officer
Knazek, Richard
Project Start
2001-09-30
Project End
2006-08-31
Budget Start
2003-09-01
Budget End
2004-08-31
Support Year
3
Fiscal Year
2003
Total Cost
$496,450
Indirect Cost
Name
Baylor College of Medicine
Department
Pediatrics
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
Bollard, Catherine M; Gottschalk, Stephen; Torrano, Vicky et al. (2014) Sustained complete responses in patients with lymphoma receiving autologous cytotoxic T lymphocytes targeting Epstein-Barr virus latent membrane proteins. J Clin Oncol 32:798-808
Brenner, Malcolm K; Gottschalk, Stephen; Leen, Ann M et al. (2013) Is cancer gene therapy an empty suit? Lancet Oncol 14:e447-e456
Sili, Uluhan; Leen, Ann M; Vera, Juan F et al. (2012) Production of good manufacturing practice-grade cytotoxic T lymphocytes specific for Epstein-Barr virus, cytomegalovirus and adenovirus to prevent or treat viral infections post-allogeneic hematopoietic stem cell transplant. Cytotherapy 14:7-11
Bonini, Chiara; Brenner, Malcolm K; Heslop, Helen E et al. (2011) Genetic modification of T cells. Biol Blood Marrow Transplant 17:S15-20
Bollard, Catherine M; Gottschalk, Stephen; Helen Huls, M et al. (2011) Good manufacturing practice-grade cytotoxic T lymphocytes specific for latent membrane proteins (LMP)-1 and LMP2 for patients with Epstein-Barr virus-associated lymphoma. Cytotherapy 13:518-22
Ahmed, Nabil; Heslop, Helen E; Mackall, Crystal L (2010) T-cell-based therapies for malignancy and infection in childhood. Pediatr Clin North Am 57:83-96
Leen, Ann M; Christin, Anne; Myers, Gary D et al. (2009) Cytotoxic T lymphocyte therapy with donor T cells prevents and treats adenovirus and Epstein-Barr virus infections after haploidentical and matched unrelated stem cell transplantation. Blood 114:4283-92
Fujita, Yuriko; Leen, Ann M; Sun, Jiali et al. (2008) Exploiting cytokine secretion to rapidly produce multivirus-specific T cells for adoptive immunotherapy. J Immunother 31:665-74
Leen, Ann M; Christin, Anne; Khalil, Mariam et al. (2008) Identification of hexon-specific CD4 and CD8 T-cell epitopes for vaccine and immunotherapy. J Virol 82:546-54
Bollard, Catherine M; Gottschalk, Stephen; Leen, Ann M et al. (2007) Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood 110:2838-45

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