IU presents an excellent environment for the development of a NGVL. The institution has built a strong gene therapy program with over eleven NIH-funded researchers pursuing clinical gene therapy. The close collaborative efforts of the gene therapy investigators has led to the successful competition for two program projects and the designation as a Centers of Excellence in Molecular Hematology. A Vector Production Facility is currently funded as a core for two existing program grants. The applicants are proposing to expand the current facility to provide viral vectors to outside investigators as a member of the NGVL. The NGVL at IU will: 1) provide a mechanism for review, generation and distribution of clinical grade vector to investigators in the gene therapy field; 2) generate vector producer cell lines and supernate intended for clinical use; 3) certify vectors for clinical use based on Food and Drug Administration (FDA) guidelines under good manufacturing practice (GMP) and good laboratory practice (GLP) specifications; and 4) provide regulatory support for investigators using vectors generated in the NGVL.
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