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.
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