NGS Revolution For Cell And Gene Therapy Products: Establishment & Monitoring Of Critical Quality Attributes

By Marie-Ange Kouassi, Scientific Content Marketing

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

Cell and gene therapies hold extraordinary promise, yet their path to patients is slowed by the difficulty of consistently verifying product quality, safety, and function. Today, many organizations rely on an assortment of single‑purpose assays to monitor critical quality attributes (CQAs), creating fragmented workflows and delays, especially when navigating tight development timelines or preparing IND filings. Advances in next‑generation sequencing are reshaping this landscape. Modern NGS approaches can assess identity, potency, purity, and safety in a single, comprehensive workflow, uncovering insights that traditional assays often miss. From single‑cell characterization to adventitious agent detection and integration site analysis, NGS brings clarity and efficiency to increasingly complex CGT pipelines. By adopting unified, data‑rich methods, teams can streamline CQA evaluation, reduce costs, and make faster, better‑supported decisions that ultimately help life‑changing therapies reach patients sooner.

Learn how a multi‑attribute NGS strategy transforms CGT development.