Development of NSG-Based Workflows for Critical Quality Attributes for Product Characterization in Cell and Gene Therapy: Biosafety and Genome Integrity

Next‑generation sequencing (NGS) is a valuable tool for testing in cell and gene therapy development and manufacturing. Biosafety testing and product characterization are essential for manufacturing, release, and comparability. Conventional assays (culture‑based detection, qPCR/ddPCR, electrophoretic methods) can be matrix‑limited, single plex, costly, and slow. NGS provides unbiased, high‑content datasets that can be queried to efficiently address product safety and characterization. We developed a suite of NGS‑based workflows to comprehensively detect adventitious agents and characterize vector and cell therapy products across diverse materials and manufacturing stages. Download the poster to learn more.