Beyond CSV: Lessons Learned from a Full-Scale GMP Validation of NGS Workflows

April 28, 2026

Next‑generation sequencing (NGS) is increasingly used for virus safety testing, supported by maturing regulatory expectations for GMP validation. In particular, ICH Q5A (R2) encourages the use of NGS for adventitious virus detection in biopharmaceutical development and manufacturing. While validation frameworks are described in the Ph. Eur. 2.6.41, practical experience from full‑scale GMP implementations remains limited. 

Genedata Selector^® has supported biopharmaceutical organizations in transferring NGS‑based assays into GMP environments. Such projects demonstrate that documentation effort, organizational readiness, and controlled change management drive project duration and complexity. NGS validation extends far beyond bioinformatics: wet‑lab readiness, IT access, QA processes, and cross‑functional coordination all critically influence timelines. As a result, bioinformatics alone cannot drive project success. This poster summarizes key lessons learned from end‑to‑end GMP validations of NGS workflows performed in a manufacturing‑relevant environment.