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.
- Automation ,
- Bioanalytical Testing ,
- Biologics ,
- Biologics Development ,
- Biologics Manufacturing ,
- Cell & Gene Therapies ,
- Cell Culture ,
- Cell Line Development ,
- Cell Therapy ,
- Cells ,
- Clonality ,
- Compliance ,
- Drug Development ,
- Gene Therapy ,
- GMP ,
- Laboratory Technology ,
- Pre-Clinical ,
- Regulatory ,
- Regulatory Compliance ,
- Regulatory Submission ,
- Single-Cell Cloning
Speakers
Alexis Rossignol, PhD, Senior Project Manager, Analytical Methods Development and Validation, Clean Cells
Alexis Rossignol earned his PhD in 2007 on the theme of anti-tumor immunology from the University of Poitiers (France). He completed his post-doctoral research in a lab dedicated to monoclonal antibody pharmacogenomics in Tours, where he developed in vitro cell-based assays to explore the functional activities of therapeutic antibodies.
In 2011, Alexis joined Clean Cells to expand the Quality Control biosafety portfolio with monoclonal antibody potency assays. He currently serves as Senior Project Manager in the Analytical Methods Development and Validation department, specializing in GMP-compliant cell-based potency assays. More recently, he oversaw the integration of a single-cell isolation service at Clean Cells. This service can support, for example, the development of monoclonal reporter cell lines in the context of cell-based potency assays to improve assay reproducibility. It can also facilitate the use of monoclonal cell substrates in the field of advanced cell and gene therapies, thereby fulfilling the requirements of regulatory agencies.
Message Presenter
Sivane Koskas, PhD, Global Product Marketing Manager, Solentim Portfolio, Advanced Instruments, LLC
Sivane Koskas serves as the Global Product Manager for the Cell Metric Portfolio at Advanced Instruments. With a foundational background in cancer genomics from her PhD studies, Sivane transitioned from academic research at the INSERM/CNRS Institute for Advanced Biosciences to a career focused on bridging scientific innovation with practical applications in the biotech industry. Her journey through roles in product marketing and management has been marked by a dedication to applying her scientific expertise to enhance product development and market strategies. At Advanced Instruments, Sivane continues to contribute her knowledge and skills towards advancing the Cell Metric Portfolio, aiming to meet the evolving needs of the cell line development community with thoughtful and effective solutions.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Scientists and engineers involved in bioproduction and gene therapy development
- Cell line development teams working with or considering working with suspension cell lines
- Regulatory affairs and quality professionals responsible for CMC and documentation of clonality
- Process development staff in biotech companies and CDMOs seeking to improve or internalize cell line workflows
What You Will Learn
Attendees will learn:
- Why demonstrating clonality is critical to gene therapy manufacturing and how image-based documentation supports regulatory compliance
- How static culture conditions impact single-cell cloning in HEK293 lines adapted for suspension
- Strategies for improving clone outgrowth and resuspension in chemically defined systems
- Real-world data from feasibility studies evaluating single-cell workflows in bioproduction settings
- Best practices for preparing regulatory-ready clonality proof in forced-suspension cell lines
Xtalks Partner
Advanced Instruments
Advanced Instruments is a global company offering a novel portfolio of analytical tools including, OsmoTECH®, a robust line of micro-osmometers to support bioprocessing and quality control (QC), and Solentim, a portfolio of best in class imaging and single-cell deposition technologies for cell line development workflows and assurance of clonality for regulatory bodies.
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