Collaboration Uses Next-Gen Sequencing for Biosafety Assessments
Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing (NGS) based biosafety assessments to detect and identify viral contaminants within biologic compounds throughout the lifecycle of the product.
In a press statement the companies report that since viral contamination poses a significant potential safety risk to patients, regulatory agencies are increasingly focusing on the use of advanced analytical technologies like NGS for detection of viral contaminants.
The NGS solution offered by the companies overcomes the primary limitation of traditional approaches that only identify a predefined, short list of viruses and instead provides a universal test for identifying any virus in a single, analysis that minimizes false negatives, the companies report.
Covance and Pathoquest will provide clients with a range of options for adventitious virus identification, including a rapid detection protocol for the critical evaluation of major issues within production processes and an approach for development and characterization of cell banks and biological production systems.
Source: Covance Inc.