The desire to move away from the use of live animal testing is a compelling argument for innovation in the biologics industry. ICH Q5A(R2) guidelines encourage the use of Next Generation Sequencing (NGS) as a replacement for in-vivo tests for adventitious virus detection, recognizing its higher sensitivity and reduced testing time.
NGS represents a broad screening assay as it can detect adventitious viral contamination in cell lines, biologics, and gene therapy products. This poster provides strategies used to overcome implementation challenges faced when commercializing cGMP NGS for routine biosafety performance, including the need for standardized workflows, appropriate controls, and data management. Additionally, investment in workforce training and cross disciplinary expertise are critical for fully leveraging NGS capabilities while maintaining compliance.
On this poster you will find the results of the NGS transcriptomic method qualification to establish quality criteria, demonstrate specificity and limit of detection (LOD) for cell banks and other cell-based samples. The assay can replace in vivo tests with broad virus detection for unknown or unexpected virus species and can complement in vitro cell culture assays.
Learn more about AgentSCREEN™ GMP Adventitious Virus Detection by NGS here.
