Nanopore Tech Sets New GMP Standard for Biopharma Safety

VIENNA, Austria & OXFORD, England – March 10, 2026 – A groundbreaking development in biopharmaceutical manufacturing promises to make critical medicines safer and more readily available. ViruSure, an Asahi Kasei company, today announced the launch of the world's first Good Manufacturing Practice (GMP) validated viral safety test based on Oxford Nanopore sequencing. The new solution provides a rapid, comprehensive method for detecting adventitious viral agents (AVAs) and is poised to transform quality control (QC) in the £300 billion global biologics market.

This first-in-class test combines ViruSure's deep expertise in pathogen safety with Oxford Nanopore's revolutionary molecular sensing technology. Designed for routine use in regulated QC environments, it aims to replace a complex web of traditional assays with a single, information-rich test, ensuring that biologic medicines like vaccines, monoclonal antibodies, and cell therapies are free from viral contamination before they reach patients.

A Technological Leap in Viral Detection

For decades, the biopharmaceutical industry has relied on a battery of tests to ensure product safety, including cell-based assays and PCR-based methods. While foundational, these traditional approaches are notoriously slow and cumbersome. A full panel of tests can take more than 28 days—and sometimes months—to complete, costing manufacturers tens to hundreds of thousands of pounds per batch and creating significant bottlenecks in production timelines.

This legacy system is also prone to limitations. Cell-based assays may fail to detect certain viruses, while PCR tests can only find contaminants they are specifically programmed to look for. This leaves a window of risk for novel or unexpected viruses. Furthermore, false positives can trigger costly and unnecessary manufacturing shutdowns and investigations, disrupting the supply of essential medicines.

The ViruSure and Oxford Nanopore solution introduces a paradigm shift. By leveraging nanopore sequencing, the test is "agnostic," meaning it can detect any viral DNA or RNA in a sample without prior knowledge of the contaminant's genetic sequence. This is achieved by passing nucleic acid strands through microscopic pores and measuring the resulting changes in electrical current, a process that generates data in real time.

"Rapid Oxford Nanopore sequencing offers a fundamentally different level of resolution for detecting viral contaminants," said Francis Van Parys, CEO of Oxford Nanopore Technologies, in a statement. "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."

A key advantage is the technology's ability to generate ultra-long sequencing reads. This provides a clearer, more complete picture of a virus's genome, allowing for more confident identification and a stark differentiation between true viral contaminants and background molecular noise.

Reshaping the Biopharma Supply Chain

The operational impact of this innovation is expected to be profound. With the biosafety testing market valued at approximately £3.2 billion, efficiency gains can have a significant financial impact. By consolidating multiple assays into a single run, the new test has the potential to shorten viral safety testing timelines by weeks, simplifying laboratory workflows and accelerating batch release.

This speed is not just about cost savings; it is a crucial component of strengthening supply chain resilience. Isolated viral contamination events can have cascading effects, leading to drug shortages, patient safety concerns, and substantial financial losses for manufacturers. By providing a faster and more accurate verdict on batch safety, the technology helps mitigate these risks, ensuring a more stable and reliable supply of medicines.

For manufacturers, the benefits are clear. Faster turnaround times mean products move from production to market more quickly, which is especially critical for advanced therapies with short shelf lives. The reduced rate of false positives minimizes unnecessary operational pauses, allowing for more continuous and predictable manufacturing schedules.

The Significance of the GMP Gold Standard

The progression from laboratory research to a validated commercial tool is a long and arduous journey. The announcement marks a critical milestone: the move from Good Laboratory Practice (GLP) to Good Manufacturing Practice (GMP) validation. While the GLP-validated version of the test, launched in August 2025, demonstrated the method's scientific integrity for non-clinical studies, achieving GMP validation is a far more significant hurdle.

GMP is the gold standard required for routine use in commercial biopharmaceutical manufacturing. It ensures that a process is not only scientifically sound but also robust, reproducible, and consistently controlled to meet the highest quality standards for products intended for human use. Achieving this required ViruSure to demonstrate that the entire workflow—from sample preparation to the complex bioinformatics pipeline analyzing the data—is standardized and suitable for its intended purpose in a regulated environment.

This achievement signals a growing acceptance of next-generation sequencing (NGS) by regulatory bodies. Authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been encouraging the industry to adopt more advanced methods, as reflected in updated guidelines like ICH Q5A(R2), which explicitly supports using NGS to complement or replace older viral safety tests. ViruSure's success provides a clear regulatory pathway for other companies to follow, likely accelerating the adoption of sequencing-based QC across the industry.

Dr. Andy Bailey, CEO of ViruSure, highlighted the test's ability to meet the complex needs of modern manufacturing. "Manufacturers need viral safety tests that detect the whole range of potential contaminants, are fast and practical for GMP environments with a low rate of false positives," he stated. "By validating nanopore sequencing for adventitious viral agent detection, our workflow has demonstrated that we can provide a robust and sensitive solution... that can strengthen safety assurances for the whole range of biological products." This new benchmark in biosafety testing ultimately translates to greater confidence for both manufacturers and the patients who depend on their life-saving therapies.