Charles River, PathoQuest validate sequencing viral safety assay as option

Charles River Laboratories International and PathoQuest SAS announced the publication of the results of a seminal study in Vaccine. This unique study demonstrated that PathoQuest’s proprietary, good manufacturing practice or GMP grade NGS-based assay had a greater capability of detecting viral contaminants when compared to in vivo assays. The results presented in this publication document that PathoQuest’s proprietary NGS approach is an effective and more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, including monoclonal antibodies, vaccines, cell and gene therapies. This update is a result of advances in scientific knowledge and biotechnologies since the release of the original ICH Q5A(R1) guideline in 1999. Examples of advances include the development of new types of products like genetically engineered viral vectors, and the availability of new and more robust viral safety technologies, like NGS. This project was funded by Charles River and PathoQuest, understanding the importance of the results for future viral safety testing strategies. “The use of NGS addresses the limitations of current testing approaches for viral contaminants and enables clients to follow the 3Rs principles of replacement, reduction, and refinement of animal-use methods. Additionally