PathoQuest, a company with expertise in genomic analysis, announced today that it has received GLP certificate of conformity following a successful inspection by the French National Agency for Medicine and Health Products Safety (ANSM). PathoQuest is the first company in France to have a facility receive such a GLP certificate from the ANSM for advanced, Next Generation Sequencing viral safety testing (“high-throughput sequencing detection of incidental replicative virus test in eukaryote cells”).
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Violaine Melen, PathoQuest’s Chief of Quality Assurance and Regulatory Affairs, stated “we are really proud of the achievement of this key regulatory milestone. Receiving this GLP certificate is the confirmation of the quality of our entire process, from receipt of a biological sample to report generation, inclusive of bioinformatics analysis and data archiving. Our processes have been validated in accordance with highly recognized validation methods and computer systems guidelines such as ICHQ2(R1), IEC 62304, 21 CRF part 11, OECD annex 17.”
Next generation sequencing-based technology for biologics testing is intended to supplement or replace traditional in-vivo or in-vitro testing methods in order to support more rapid and robust decision-making as a part of the QC process. Jean-François Brepson, PathoQuest’s CEO, commented “Thanks to efficient teamwork, PathoQuest is now able to offer GLP-certified viral safety testing based on our proprietary NGS approach. This certification provides the company with a significant new market opportunity in addition to the current testing we perform in a R&D environment. Our innovative QC process is particularly adapted to biotech and biopharma companies developing Advanced Therapy Medicinal Products (ATMPs), vaccines and other biologicals.”
PathoQuest offers biopharmaceutical companies a game changing Genomic approach to secure the biosafety of biological drugs like cell & gene therapy products, vaccines and recombinant. It allows to reduce time to market of innovative treatments.
PathoQuest’s technology combines a Next-Generation Sequencing (NGS) platform with a proprietary sample preparation processes completed by a proprietary pathogen genome sequence databases and automated analysis pipeline.
PathoQuest has signed in 2018 a strategic partnership with Charles River Lab (Boston, USA).
Based on its technological platform, PathoQuest has also developed a metagenomic test direct from blood (iDTECT®) to improve the diagnosis of Bloodstream infections and fight against Antimicrobial Resistance (AMR)