Next generation sequencing (NGS), also known as high-throughput sequencing, is intended to supplement or replace traditional in vivo or in vitro testing methods for biologics testing.
In January 2020, PathoQuest, a strategic partner of ours and expert in genomic analysis, announced that it received its GLP certificate from the French National Agency for Medicine and Health Products Safety (ANSM).
"PathoQuest's GLP certificate is a testament to their commitment to quality from start to finish," said Kerstin Dolph, CVP of Global Biologics Testing Solutions. "Their testing solutions provide rapid, reliable analysis, and we are excited to continue our partnership and provide their services to our clients."
PathoQuest is the first company in France to have a facility receive a GLP certificate from the ANSM for advanced, next generation sequencing viral safety testing. Its proprietary NGS protocols support more rapid and robust decision-making as a part of the QC process.
NGS technology is now widely adopted and standards such as ICH Q2 (R1) are under revision by regulatory authorities to include and take advantage of this 3R-compliant method.
Charles River is partnering with PathoQuest to offer biotech companies a suite of NGS-based solutions including viral safety testing, cell line characterization, and full genome sequencing. If you'd like to ask our experts about NGS and how it can help your program, contact us at [email protected].