NGS In GMP Manufacturing: Reducing Risk, Increasing Return

By Christoph Bredack, Business Account Manager

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

The regulatory landscape for viral safety is undergoing a pivotal shift as next‑generation sequencing (NGS) gains formal recognition across global guidelines. With its inclusion in ICH Q5A(R2) and reinforced guidance from FDA, EMA, WHO, and the European Pharmacopoeia, NGS has moved firmly into the realm of validated, GMP‑aligned methodologies for detecting adventitious viruses. This evolution signals a broader industry transition toward molecular, high‑resolution tools capable of strengthening risk‑based quality strategies.

Implementing NGS, however, requires more than scientific expertise. It demands robust infrastructure, validated workflows, coordinated teams, and platforms that ensure data integrity, traceability, and scalability. As organizations consider when and how to bring NGS in‑house, the long‑term ROI, operational control, and regulatory readiness become central factors.

Explore the regulatory momentum, practical implementation needs, and strategic advantages that position NGS as a core capability in modern CMC and manufacturing.