Development of a Highly Efficient, Documented Workflow for Making Clonal Cell Banks of Gene-Edited iPSCs

As cell therapy companies plan for future transfer from process development to clinical manufacturing, they look to adopt robust workflows that are designed to best manage consistency, quality of product and meet with appropriate regulatory requirements and manufacturing best practices. We previously demonstrated the significant improvement in utilizing VIPS and MatriClone in an iPSC single cell cloning workflow of a parental cell line, seeing a significant increase in the number of clonal colonies per 96 well plate compared with limiting dilutions. An additional benefit of the VIPS system is the ability to capture daily whole well images (from Day 0 onwards) which enables tracking of colony outgrowth for clonal assurances, in addition to quality assurance. Importantly, we demonstrated that the hiPSC clones selected for banking maintained their characterization criteria of pluripotency marker expression and karyotype.