Indiana University Vector Production Facility (IUVPF)

Abstract

The Indiana University (IU) School of Medicine established a Vector Production Facility (VPF) in 1995 to manufacture GMP grade retroviral vectors. The principle purpose was to facilitate scientists and physicians funded by the NIH in initiating Phase I/II gene therapy clinical trials. The first production facility was built into existing laboratory space, thus with time, presenting space and design challenges. In addition, the demand for lentiviral vectors was increasing in the early 2000s, as did requests for GMP viral vectors in developing gene therapy products. Thus, a new facility, balancing the need to generate vectors in a cleanroom environment under FDA regulations, while also adhering to NIH guidelines for the safe handling of vector products, was designed. This BSL3 capable cleanroom facility was built for the purpose of manufacturing GMP retroviral and lentiviral vectors and was opened at IU in early 2009.