Validation-Ready NGS Workflows for GMP-Compliant Biosafety Testing

Enhance biosafety testing of advanced therapies with a robust, GMP ‑validation-ready‑ digital solution that streamlines the next-generation sequencing (NGS) data lifecycle — from sample registration to reporting.

Genedata Selector^® automates and standardizes complex NGS workflows, delivering accurate, reproducible, and scalable analysis across short‑ and long‑read assays. Integrated analysis guides called Playbooks simplify data processing and support rapid adventitious agent detection (AAD) to ensure product integrity, safeguard patient health, and meet regulatory standards.

With intuitive, ready-to-use quality control(QC) pipelines, the software simplifies NGS data management and visualization while accelerating decision-‑making through automated genomic insights, multi-attribute method (MAM) support, and built‑-in go/no‑-‑go criteria. The configurable pipelines of Genedata Selector manage long-read alignment, read metric calculation, QC, and limit of detection (LoD) estimation, enabling precise identification of adventitious agents. By unifying sample tracking, data analysis, documentation, and reporting into a single source of truth, this NGS analysis software empowers biopharma teams to efficiently assess Critical Quality Attributes (CQAs) including purity, stability, and identity — while maintaining GMP compliance, and driving data-driven‑ innovation in cell line development.

In this application note, explore how end-to‑-‑end digitalization of NGS workflows improves operational efficiency, reduces validation burden, and supports modern drug development — from early research to manufacturing and delivery.