PathoQuest Receives GMP Certification for Its NGS-based Quality Control Testing Services of Biological Drugs
PARIS--(BUSINESS WIRE)--PathoQuest, a leading contract research organization (CRO) for the biosafety testing of biologics with Next-Generation Sequencing (NGS) technologies, today announced that it has obtained a Good Manufacturing Practices (GMP) certificate for its quality control testing activities at its French-based facilities in Paris (France), following a recent inspection by the French National Agency for the Safety of Medicine 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 Medicinal Products and Human Investigational Medicinal Products.
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This GMP certification acknowledges PathoQuest's testing activities meet the established high-quality control standards required by the biopharmaceutical industry. Biotech and biopharma companies may now transition from early-stage projects to more advanced clinical phases and commercial batch release using the power and precision of the NGS technology. PathoQuest today offers viral safety testing services and genetic characterization of biologics.
"Obtaining the GMP certification confirms that our quality management system meets the requirements and is at the expected level by the health authorities,” stated Violaine Mélen, PharmD, PathoQuest’s Chief Quality Assurance & Regulatory Affairs Officer and Qualified Person. The GMP certification for our biosafety testing services completes our GLP certificate obtained in January 2020 and the Pharmaceutical Establishment status achieved in September 2020. Offering GMP-grade genomic testing services is our pledge of quality to the biopharmaceutical industry, the health authorities and for the safety of the patient.
“Gaining this GMP certification is a major milestone in the implementation of PathoQuest’s growth strategy and strengthens our leadership in the quality control testing of biologics,” commented Jean-Francois Brepson, PathoQuest’s CEO. "By offering these testing services we will enable our clients to entrust their vaccine, cell and gene therapy, and other innovative therapies projects to PathoQuest, from early preclinical phases to commercial supply. We believe this represents a tremendous advantage for biopharmaceutical companies when they evaluate contract manufacturing alternatives that are faster, safer and 3R-compliant at a Good Manufacturing Practice grade. Those assets make PathoQuest the ideal partner.”
PathoQuest’s GMP certificate is available for our clients to download from our website along with the company’s current GLP certificate and the notice of achieving Pharmaceutical Establishment status.
PathoQuest offers biopharmaceutical companies a game-changing genomic approach at R&D, GLP and GMP grades to ensuring the biosafety of biologics like cell and gene therapy products, vaccines, and recombinant drugs. It enables a reduction in 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 sequences databases. PathoQuest entered into a strategic partnership with Charles River Laboratory (Boston, USA) in 2018.