Scale-up of lentiviral vectors for gene therapy: advances and challenges

Abstract

Growing interest in the use of lentiviral (LV) vectors for gene therapy applications has resulted in demand for production processes that are amenable to large scale. However, up-scaling LV manufacturing poses a number of challenges for process developers and regulatory bodies, which need to be overcome in order to cost effectively generate a gene therapy product in large quantities. Recently there has been progress in developing workflows capable of producing and processing LV vector at sufficient levels for human gene therapy applications. Accordingly, this article will cover the current state of LV upstream and downstream processing, ongoing challenges of up-scaling manufacturing, recent advances and improvements, and future perspectives.