Advanced NGS Techniques For Cell Line Characterization In Cell And Gene Therapy

By Valentina Armiento, Scientific Communications

This content is brought to you by Genedata, a Danaher Operating Company.

Cell and gene therapies depend on precise, reliable characterization of the cell lines and materials used to create them. As these therapies increasingly rely on living systems, ensuring genetic stability, verifying identity, assessing potency, and detecting contaminants are essential steps to safeguard product quality. Next‑generation sequencing (NGS) has become a pivotal tool for this work, enabling detailed analysis of genetic modifications, integration sites, copy number variation, and safety attributes across the development lifecycle. Yet integrating multiple NGS assays brings data‑management challenges—from validation complexity to analysis bottlenecks—that can slow progress and introduce risk. Bringing NGS workflows in‑house, supported by purpose‑built software, allows organizations to streamline analysis, reduce data silos, and maintain compliance across diverse advanced therapy programs.

Explore how strategic use of in‑house NGS and specialized informatics strengthens CQA assessment and accelerates development of safer, more effective therapies.