Scaling non-viral cell therapy approaches for solid tumor treatments

Abstract

The need for standardization and high manufacturing success rates are critical drivers of innovation in cell therapy. Thermo Fisher Scientific has built a fit-for-purpose portfolio of modular instrumentation platforms designed to support closed, large-scale cell manufacturing, enabling automation of the end-to-end manufacturing workflow. Automation of the isolation / activation and bead removal steps ensure that the manufacturing workflow can be closed at the outset of the process. The transformation of immune cells into a functional therapeutic can involve a genetic modification step. There has been a renewed interest in non-viral gene modification approaches as an alternative to viral vectors due to the increased focus on personalized therapies in solid tumor indications. Non-viral electroporation is emerging as the method of choice, especially given demonstrated efficacy, safety benefits, and flexibility allowing the utilization of CRISPR-Cas9 gene editing. This article explores the emergence of modular closed, automated technologies and non-viral gene engineering tools that are fit-for-purpose for large-scale cell therapy manufacturing and discusses their application for a non-viral engineered cell therapy process.