AgentSCREEN™ Adventitious Virus Detection by NGS as a Replacement for In Vivo Tests

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. Minaris Advanced Therapies has developed AgentSCREEN™: Adventitious Virus Detection in a Cell Bank Sample by Next Generation Sequencing to provid A e broad, agnostic (non-targeted) detection capability across viral taxa and genome types. AgentSCREEN™ is a transcriptomic approach that examines all the messenger RNA (mRNA) in a cell bank sample for the presence of viral RNA transcripts. All viruses have a mRNA stage in their lifecycle. The method is designed to detect any active viral infection, from RNA and DNA viruses.  A custom bioinformatics pipeline compares sequencing data with known viral genomes and a database of endogenous sequences to accurately identify viral contaminants and remove false positives. We present results of the AgentSCREEN method quantification to establish quality criteria, demonstrate specificity and limit of detection (LOD) for cell banks and other cell-based samples. AgentSCREEN™, offered GMP, aligns with the global initiative to reduce animal testing with NGS for biosafety. 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.