Back to the future: where are we taking lentiviral vector manufacturing?

Published: 18 December 2018
Expert Insight
Hanna P Lesch
Hanna P Lesch
Dr Lesch is the Gene Therapy Unit Director of Kuopio Center for Gene and Cell Therapy (KCT) in Finland. Her research interest is focused on gene therapy and translational development, including early stage analyticals and the development of scalable, robust manufacturing processes operating under current regulatory guidelines. She also has research and development affiliations with Finvector and FKD Therapies. She has wide experience of all the most commonly used viral vectors (lentivirus, AAV, adenovirus and baculovirus) and a research interest in vascular biology and cancer therapy. Her PhD was in Molecular Medicine, obtained from the University of Kuopio. She followed up her PhD with post doc work at the University of California San Diego UCSD, CA, USA, and the University of Eastern Finland, Kuopio, Finland, concentrating on the understanding of gene regulation and the role of enhancer RNAs in macrophages. She has several patents related to vector manufacturing.

From more than 200 clinical trials involving lentiviral vectors, only a handful of products have reached marketing approval. One reason for this may be the technical bottleneck in large-scale lentiviral vector manufacturing. Today there are several upstream and downstream technology solutions, which claim to support clinical manufacturing at large scale. These still have several limitations, such as a complex production methodology and the relatively high cost of the goods. The fragile nature of the vector further causes its own challenges. No one knows yet where the future will take us. This insight covers an overview of the current technology and discusses the possible future solutions for lentivirus manufacturing.

Read now