NEW YORK (GenomeWeb News) – Covance and PathoQuest said today that the companies will collaborate to develop a next-generation sequencing-based assay for biosafety testing for the pharmaceutical industry.
PathoQuest is a startup based in Paris and is developing next-gen sequencing-based infectious disease diagnostics. In the collaboration with Covance, the companies will develop assays to screen pharmaceutical products for viral contaminants.
The companies will make use of PathoQuest's technology and Covance's regulatory expertise. The NGS-based platform will be able to identify viral contaminants within biologic compounds, including monoclonal antibodies and vaccines, throughout the entire lifecycle of the product, they said.
The companies plan to provide a range of options for clients, including a rapid detection protocol for assessing problems within the production process and a more comprehensive assay that can be used to assess cell banks and biological production systems.
"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," Raymond Kaiser, global vice president of biopharmaceutical chemistry, manufacturing and control solutions for Covance, said in a statement.
PathoQuest's capability "dovetails perfectly with our [chemistry, manufacturing, and control] analytical solutions to provide our clients access to the latest technology and patients with safer medications," he added.
According to the companies, the industry is increasingly adopting NGS as a means to screen pharmaceutical products for viral contaminants. Next-gen sequencing can provide a single, comprehensive test for identifying viruses.
"In an evolving regulatory environment, we anticipate that NGS will soon become the standard approach in biosafety assessment," PathoQuest Co-founder and CEO Luc Boblet said in a statement. "Our technology will help clients meet that standard now and well into the future."
Earlier this year, PathoQuest raised €3.8 million ($5.1 million) in a Series B private equity funding round, which it said it would use to fund a clinical trial of its NGS-based diagnostic assay for identifying pathogens in two days. At the time, it said it planned to commercially launch the assay in 2015.