ViruSure Launches First GMP-Validated Viral Safety Test Based on Oxford Nanopore Sequencing

ViruSure, an Asahi Kasei company and global leader in pathogen safety testing for biopharmaceuticals, announced the launch of the world’s first GMP-validated adventitious viral agent (AVA) detection test based on Oxford Nanopore sequencing. Designed for use in regulated biopharmaceutical quality control (QC) environments, this process is designed to ensure biologics medicines are free from viral contamination.

The first-in-class solution combines Oxford Nanopore’s rapid, information-rich molecular sensing technology with ViruSure’s GMP expertise, delivering broader viral detection and a more streamlined approach to viral safety testing in commercial biologics manufacturing. This has the potential to enable rapid testing and support confidence in batch release, thus strengthening supply chain resilience.

The launch follows the industry’s first GLP-validated (Good Laboratory Practice) AVA detection test using Oxford Nanopore sequencing in August 2025. Progression to GMP (Good Manufacturing Practice) validation, the standard required for routine use in commercial biopharmaceutical manufacturing, demonstrates the regulatory readiness of Oxford Nanopore sequencing-based approaches for viral safety testing and marks an important step toward wider adoption in regulated environments.

Francis Van Parys, CEO of Oxford Nanopore Technologies, said, “Rapid Oxford Nanopore sequencing offers a fundamentally different level of resolution for detecting viral contaminants. Through this collaboration with ViruSure, that capability is now available in a GMP-validated format, making advanced sequencing accessible for routine safety testing across biologics manufacturing.”