ViruSure, a provider of pathogen safety testing for biopharmaceuticals, on Thursday announced the launch of the first Good Laboratory Practice (GLP)-validated adventitious viral agent (AVA) detection test using nanopore-based sequencing.
Developed in collaboration with molecular sensing technology company Oxford Nanopore Technologies (LON:ONT), the test offers rapid, sensitive, and cost-effective viral screening for biopharmaceutical manufacturers, capable of detecting viral contaminants regardless of type.
Powered by Oxford Nanopore's molecular sensing platform, the solution delivers faster time-to-result compared to traditional methods, which often take over two weeks and can miss contaminants or yield false positives.
This new method addresses a critical challenge in the USD20bn biomanufacturing market, where viral contamination risks can disrupt production and lead to biologic, vaccine, and cell and gene therapy shortages.
At least USD4bn of the market is tied to AVA testing, an area under increased regulatory focus for faster, more reliable solutions.
ViruSure and Oxford Nanopore plan to extend their offering with a forthcoming Good Manufacturing Process (GMP)-validated version of the test.
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