Developing novel lentiviral vectors into clinical products

Abstract

Gene therapy vectors based on murine retroviruses have now been in clinical trials for over 20 years. During that time, a variety of novel vector pseudotypes were developed in an effort to improve gene transfer. Lentiviral vectors are now in clinical trials and a similar evolution of vector technology is anticipated. These modifications present challenges for those producing large-scale clinical materials. This chapter discusses approaches to process development for novel lentiviral vectors, highlight considerations, and methods to be incorporated into the development schema.