Demonstrating the clonal origin of therapeutic cell lines is a regulatory requirement for the production of gene therapies and other biologics. For many bioproduction workflows, this involves image-based evidence of clonality — an approach that supports product quality and consistency throughout the lifecycle of a therapy.
However, establishing clonality in HEK293-derived cell lines presents unique challenges, particularly when these cells are optimized for growth in agitated suspension. To ensure compliance, the early stages of single-cell cloning must occur under static conditions, which can impact cell viability, outgrowth and recovery.
In this webinar, the speakers will discuss how to achieve image-based clonality verification in suspension-adapted HEK293 cell lines while ensuring regulatory compliance. They will share findings from a feasibility study evaluating cloning performance and outgrowth in a chemically defined culture system. They will also examine how growth-promoting and suspension-supporting culture supplements influence clone outgrowth and the ability of cells to return to suspension conditions.
Register for this webinar to gain insights into practical approaches for preparing clonality documentation in settings that reflect the demands of modern gene therapy development, using an automated, image-based single-cell seeding system designed for clonality assurance in GMP-ready workflows.