Scaling non-viral cell therapy approaches for solid tumor treatments

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.

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