As cell therapies advance toward mainstream clinical use, manufacturers face increasing pressure to develop robust, scalable, and highly efficient processes for engineering complex immune cell populations. Achieving consistent delivery of genome-editing and expression-modifying biomolecules into primary human cells, particularly T cells, remains a key bottleneck for therapeutic production. To address these challenges, MaxCyte® has optimized GMP-compatible cell engineering workflows on the ExPERT™ platform, which was built for scalable electroporation and is supported by an FDA Master File. These workflows enable reliable, high-efficiency delivery of a broad range of payloads, including mRNA or plasmid DNA, to cell types historically considered difficult to transfect.

In this study, we demonstrate how these standardized workflows enable the manufacture of immune cells expressing tumor-targeting receptors, such as CARs and TCRs, while maintaining high viability, functionality, and phenotypic integrity. We highlight processes that enable both transient and stable expression through mRNA transfection or transposon-based integration. Importantly, these workflows were designed for seamless scalability, enabling efficient transition from research-scale optimization to therapeutic-scale production without process redesign.

Together, these results highlight a manufacturing-ready, platform-based approach for producing engineered immune cells with reproducible quality and performance. By enabling efficient, scalable editing across multiple immune cell types, this framework accelerates the translation of next-generation cell therapies from development to clinical manufacturing.