NGS-Based Assays In Cell And Gene Therapy: Enhancing Product Development

By Marie-Ange Kouassi, Scientific Content Marketing

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

Next‑generation sequencing (NGS) is rapidly becoming a cornerstone of quality assurance for cell and gene therapies, offering the resolution and speed needed to evaluate complex, living therapeutics. As CGTs expand into new clinical areas, developers face growing pressure to verify biosafety, genetic integrity, and product consistency using methods that can keep pace with increasingly sophisticated modalities. NGS helps meet these demands by enabling deep characterization from minimal sample input—crucial in workflows where material is scarce and timelines are tight.

From identifying adventitious agents and validating viral vectors to monitoring stability, confirming gene edits, and supporting single‑cell potency assessments, NGS strengthens decision‑making across the development lifecycle. Regulatory bodies now recognize NGS as a preferred tool for defining critical quality attributes and ensuring patient safety.

Access the full article to gain clarity on where NGS offers the greatest impact and how thoughtful implementation can streamline CGT development from discovery through manufacturing.