Innovative biosafety testing approach provides a flexible testing solution to all biotherapeutic clients
New Jersey-based development company Covance and pathogen detection pioneer PathoQuest are to provide Next-Generation Sequencing (NGS) based biosafety assessments. This innovative biosafety testing approach, combined with Covance’s regulatory expertise, provides a flexible testing solution to all biotherapeutic clients and makes biologic medicines safer.
The NGS-based platform can detect and identify viral contaminants within biologic compounds (such as mAbs or vaccines) throughout the entire lifecycle of the product. This NGS solution overcomes the primary limitation of traditional approaches that identify only a predefined shortlist of viruses, as it provides a universal test for identifying any virus in a single analysis that minimises false negatives.
‘In an evolving regulatory environment, we anticipate that NGS will soon become the standard approach in biosafety assessment,’ said Luc Boblet, co-founder and CEO of PathoQuest.