ViruSure Introduces GMP-Validated Nanopore Test for Viral Contamination Detection

• ViruSure has launched the first GMP-validated adventitious viral agent detection test based on Oxford Nanopore sequencing for biopharmaceutical quality control. 

• The test is designed to detect viral contamination in biologics manufacturing and support regulatory-compliant safety testing. 

ViruSure has launched what it describes as the first Good Manufacturing Practice (GMP)-validated viral safety test based on Oxford Nanopore sequencing, designed for use in regulated biopharmaceutical quality control environments. The test is intended to ensure biologic medicines are free from viral contamination during manufacturing. 

The new assay focuses on the detection of adventitious viral agents (AVAs), which can arise during the production of biologics, vaccines, and advanced therapies. The method uses nanopore sequencing technology to identify viral contamination across a broad range of virus types within a single workflow. 

Viral contamination remains a key risk in biopharmaceutical manufacturing, with potential impacts on production timelines and product supply. Traditional detection methods can require multiple assays and extended testing timelines, often taking weeks to generate results. 

The GMP-validated version of the test is designed to support use in regulated environments, including quality control settings where compliance with manufacturing standards is required. According to the company, the approach provides data to support decision-making on product safety and release. 

“The development of this cutting-edge test…marks a major advancement in the industry’s ability to detect a wide range of contaminants.” 

Andy Bailey, Chief Executive Officer of ViruSure