In this free webinar, learn why demonstrating clonality is critical to gene therapy manufacturing and how image-based documentation supports regulatory compliance. Attendees will learn how static culture conditions impact single-cell cloning in HEK293 lines adapted for suspension. The featured speakers will share strategies for improving clone outgrowth and resuspension in chemically defined systems. Attendees will gain insights from real-world data from feasibility studies evaluating single-cell workflows in bioproduction settings. The speakers will share best practices for preparing regulatory-ready clonality proof in forced-suspension cell lines.
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.
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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.
Join Alexis Rossignol, PhD, Senior Project Manager, Analytical Methods Development and Validation, Clean Cells; and Sivane Koskas, PhD, Global Product Marketing Manager, Solentim Portfolio, Advanced Instruments, LLC, for the live webinar on Thursday, September 25, 2025, with Broadcast 1 – UK & Europe at 9am BST (10am CEST) and Broadcast 2 – North America at 10am EDT (7am PDT).
For more information, or to register for this event, visit Advancing Gene Therapy Development with Monoclonal HEK293 Cell Isolation for Regulatory Compliance.
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Contact:Vera KovacevicTel: +1 (416) 977-6555 x371Email: vkovacevic@xtalks.com
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