Covance Inc. and Pathoquest are collaborating to provide next-generation sequencing (NGS) based biosafety assessments. This innovative biosafety testing approach is designed to provide a flexible testing solution to all biotherapeutic clients and make biologic medicines safer.This 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. 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.
“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, PhD and 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, and our technology helps clients meet that standard now and well into the future,” said Luc Boblet, PhD, co-founder and CEO of Pathoquest.
With several high-profile instances of viral contamination of commercially released biologic drugs detected by NGS, the industry is increasingly adopting the technology. The NGS solution offered by Covance and Pathoquest overcomes the primary limitation of traditional approaches that only identify a predefined, short list of viruses. In contrast, this new solution 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, 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. For small, emerging and virtual biotech companies, which represent a growing and valued segment of Covance’s client base, this solution allows them to access state-of-the-art technology early in the development process to increase the value and safety profile of their molecule.
Date: November 5, 2013
Source: Covance Inc.
Filed Under: Drug Discovery
