Viral Safety and Control: Next-Generation Sequencing for Viral Clearance and Contamination Detection in Biopharmaceutical Products

• NGS enables unbiased detection of both known and novel viruses, significantly improving sensitivity over traditional methods. • Integration of NGS into viral clearance validation can streamline regulatory submissions and reduce time-to-market. • Standardization and validation of NGS workflows are essential for regulatory acceptance and reproducibility. • NGS has the potential to replace multiple conventional assays, offering cost and efficiency benefits in biopharmaceutical manufacturing.