PathoQuest Receives GMP Certification for Its NGS-Based Quality Control Testing Services for Biologics
PARIS–(COMMERCIAL THREAD) –PathoQuest, a leading contract research organization (CRO) for biosafety testing of biologics with Next Generation Sequencing Technologies (NGS), today announced it has obtained a Good Manufacturing Practices (GMP) Certificate ) for its quality control testing activities at its facilities based in Paris (France), following a recent inspection by the National Agency for the Safety of Medicines and Health Products (ANSM). PathoQuest is the first French CRO to offer GMP-grade NGS-based testing services to assess the quality control of human drugs and human investigational drugs.
This GMP certification recognizes that PathoQuest’s testing activities meet established high quality control standards required by the biopharmaceutical industry. Biotech and biopharmaceutical companies can now move from early stage projects to more advanced clinical phases and commercial batch release using the power and precision of NGS technology. PathoQuest now offers virus security testing services and genetic characterization of biological productss.
“Obtaining GMP certification confirms that our quality management system meets the requirements and is at the level expected by the health authorities”, said Violaine Mélen, PharmD, Head of Quality Assurance and Regulatory Affairs at PathoQuest and Qualified Person. GMP certification for our biosafety testing services complements our GLP certificate obtained in January 2020 and pharmaceutical establishment status obtained in September 2020. Providing GMP quality genomic testing services is our pledge of quality to the biopharmaceutical industry, health and safety authorities. of the sick.
“Obtaining this GMP certification is a major step in the implementation of PathoQuest’s growth strategy and strengthens our leadership in quality control testing of organic products ”, commented Jean-Francois Brepson, CEO of PathoQuest. “By offering these testing services, we will enable our customers to entrust PathoQuest with their vaccine, cell and gene therapy and other innovative therapy projects, from early preclinical phases to commercial supply. We believe this is of huge benefit to biopharmaceutical companies when evaluating contract manufacturing alternatives that are faster, safer, and 3R compliant at a good manufacturing practice level. These strengths make PathoQuest the ideal partner.
PathoQuest’s GMP Certificate is available for our customers to download from our website along with the company’s current GLP Certificate and Notice of Pharmacy Establishment Status.
PathoQuest offers biopharmaceutical companies a revolutionary genomics approach at R&D, GLP and GMP levels to ensure the biosafety of biological products such as cell and gene therapy products, vaccines and recombinant drugs. It reduces the time to market for these innovative treatments. PathoQuest’s technology combines an NGS platform with proprietary sample preparation processes, followed by an automated analysis pipeline using the company’s proprietary pathogen genome sequence databases. PathoQuest entered into a strategic partnership with Charles River Laboratory (Boston, USA) in 2018.
For more information, visit www.pathoquest.com or contact us at [email protected]