Development of a highly efficient, documented workflow for making clonal cell banks of gene-edited iPSCs
As synthetic biology companies and allogeneic iPSC cell therapy companies plan for future transfer of single cell cloning projects from process development to clinical manufacturing, they will need to adopt platforms and processes which can be directly translated to GMP manufacturing.
We previously demonstrated the significant improvement in utilizing VIPS™ together with MatriClone™ in an iPSC single cell cloning workflow for parental cell lines. Gene-editing of the iPSCs adds a further level of complexity to this workflow. In this latest application note of the iPSC series, we have demonstrated the workflow for a single gene edit, including confirmation of correct sequence and maintenance of pluripotency prior to banking. As part of this process we also documented clonal origin which would be able to support an IND application. We also speculate on how this workflow could be expanded for projects requiring multiple gene-editing events.
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