Webinar: A framework for genomic integrity testing across the development lifecycle

Building Safer Cell and Gene Therapies with Genomic Integrity Testing

Genomic integrity is one of the most critical considerations in cell and gene therapy (CGT) development. Structural changes introduced during genome editing can lead to serious consequences, including oncogenesis or clonal outgrowth. Regulatory agencies now emphasize comprehensive genomic integrity assessment as a requirement, with structural variant analysis becoming essential across every stage of development.

Traditional cytogenetic methods like G-banding often miss rare or complex events. In contrast, advanced single-cell cytogenetic tools can analyze hundreds of cells simultaneously, detecting both rare and prevalent structural variants with far greater precision.

In this on-demand webinar, you’ll gain practical insights into applying genomic integrity testing in real-world workflows. Case studies—including a CD33 CAR-NK cell therapy for AML—demonstrate how structural variant testing confirms transgene accuracy, rules out off-target effects, and supports the safe release of therapeutic cells for patient use.

What you’ll learn:

• How to integrate genomic integrity analysis—including chromosomal rearrangements, insertions, and transgene mapping—into QC workflows to align with evolving FDA guidance.

• Why detecting rare variants at the single-cell level is critical to identifying risks like clonal proliferation or insertional mutagenesis before they reach the clinic.

• How advanced cytogenetic tools are setting new benchmarks for structural variant detection across therapy types and development phases.