ESTABLISHMENT OF ADENOVIRAL VECTOR PRODUCTION LAB AT BAYLOR

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. DESCRIPTION (provided by applicant): 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.