Enabling NGS-Based Product Characterization And Biosafety Assays In GxP Environments

By Valentina Armiento, Scientific Communications

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

Next‑Generation Sequencing (NGS) is rapidly becoming a cornerstone of biopharmaceutical product characterization and biosafety, offering heightened sensitivity, speed, and cost-efficiency compared to classical assays. As regulatory authorities formalize expectations for NGS-based methods, including the revised ICH Q5A(R2) guideline, biopharma organizations must navigate evolving requirements for assay validation, data integrity, and compliant computational workflows. Learn more about the shifting regulatory landscape and the growing role of NGS in GMP environments, from adventitious agent detection to the characterization of cell and gene therapy products, as well as the operational challenges companies face as they validate complex, multi‑instrument NGS workflows across sites.

Gain clarity on how to align emerging NGS applications with established quality frameworks and prepare for successful implementation.