Adventitious Agent Testing By NGS: A Comprehensive Solution With Targeted And Non-Targeted Approaches

Viral safety assurance for biologics requires complementary assays that deliver broad detection coverage and sufficient sensitivity. As regulations increasingly recommend molecular methods in place of traditional animal-based testing, assay selection must evolve without introducing gaps in virus detection. Non-targeted next-generation sequencing can provide wide-ranging detection of known and novel viruses, while targeted molecular methods offer focused sensitivity for specific viral risks. Combining these approaches during cell line characterization can support a robust, orthogonal testing strategy tailored to the biological system and its potential contaminants.

Learn how to build an effective molecular testing strategy for biologics viral safety.