Covance and PathoQuest, a developer of pathogen detection systems, have entered an exclusive agreement to provide Next-Generation Sequencing (NGS)-based biosafety assessments.
 
This biosafety testing approach, combined with Covance’s regulatory expertise, aims to provide a flexible testing solution for clients and to make biologic medicines safer. The new NGS-based platform is designed to 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. “As a cutting-edge company in the field of NGS-based virus identification, PathoQuest’s capability dovetails perfectly with our CMC analytical solutions to provide our clients access to the latest technology and patients with safer medications.”
 
“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 chief executive officer of PathoQuest.
 
The companies 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 a more comprehensive approach for development and characterization of cell banks and biological production systems.