This biosafety testing approach, combined with Covance’s regulatory experience, provides a flexible testing solution to all biotherapeutic clients and makes biologic medicines safer.
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 new NGS-based platform can detect and identify viral contaminants within biologic compounds (such as monoclonal antibodies or vaccines) throughout the entire lifecycle of the product.
“This collaboration will provide Covance clients with a high-quality solution to the critical problem of viral contamination of biologics during development and in released product,” said Raymond Kaiser, Ph.D., global vice president of biopharmaceutical chemistry, manufacturing and control (CMC) solutions for Covance.
“Covance’s global footprint and extensive experience in BioCMC development, together with their established in-house biosafety testing capabilities, offer perfect synergies to help clients access our NGS-based adventitious assay globally. In an evolving regulatory environment, we anticipate that NGS will soon become the standard approach in biosafety assessment. Our technology will help clients meet that standard now and well into the future,” said Luc Boblet, Ph.D., co-founder and CEO of PathoQuest.
The industry is increasingly adopting the technology, with several high-profile instances of viral contamination of commercially released biologic drugs detected by NGS. The NGS solution offered by Covance and PathoQuest overcomes the primary limitation of traditional approaches that identify only a predefined short list of viruses. NGS provides a universal test for identifying any virus in a single, comprehensive analysis that minimizes false negatives.
Covance and PathoQuest will provide clients with a wide range of options for adventitious virus identification. This includes a rapid detection protocol for the critical evaluation of major issues within production processes and a more comprehensive approach for development and characterization of cell banks and biological production systems. For small, emerging and virtual biotech companies, representing a growing and valued segment of Covance’s client base, this solution allows them access to a unique technology early in the development process that will increase the value and safety profile of their molecule.