PathoQuest SAS and its strategic partner Charles River Laboratories International, Inc. has announced the establishment of U.S. subsidiary, PathoQuest, Inc. along with the construct of a new state-of-the-art next-generation sequencing (NGS)-based testing laboratory at Charles River’s site in Wayne, PA.

The establishment of this lab will enhance the strategic partnership between the two companies. It will also expand Charles River’s and PathoQuest’s capabilities to meet client needs by providing a fully integrated and reliable solution for rapid viral safety testing of biologics, notably advanced therapeutic medicinal products (ATMPs) and vaccines.

The expanded relationship between PathoQuest and Charles River will offer North American biotechnology companies an NGS testing facility in the U.S. that identifies adventitious agents using PathoQuest’s rapid, in vitro, comprehensive testing approach which accelerates development timelines of biologics without compromising safety and efficacy.

This NGS approach can also be utilized for the genetic characterization of cell lines. The partnership between Charles River and PathoQuest provides clients with the most sensitive and rapid testing methodologies to help ensure the safety of products produced by the biopharmaceutical industry.

Construction of PathoQuest’s new office and laboratory facility is scheduled to begin in late 2020 with NGS services expected to be available in 2021.

Once complete, the lab will be aligned with PathoQuest’s existing lab in Paris and offer testing that adheres to Current Good Manufacturing Practices (CGMP) in accordance with U.S. Food and Drug Administration guidelines.

This solution will offer the biopharmaceutical industry a comprehensive offering of testing services performed within the same facility, enabling rapid and reliable support for biologics development and quality control testing.

Charles River’s Wayne facility supports the development of biological products, including cell line characterization, viral safety, and viral clearance studies. Charles River has made an additional direct investment in PathoQuest to help fund the establishment of this new facility and to support the expansion of PathoQuest’s testing platform into North America.