Quality
CUSTOMER CHALLENGE
In order to produce and release biopharmaceutical products, manufacturers must follow strict Good Manufacturing Practice (GMP) guidelines. These regulations apply to all aspects of product manufacturing, including QC testing and release assays. Taking the burden of testing on internal resources is often not practical nor desirable, especially for high complexity systems such as NGS which may not be routinely run in-house. Maintaining validation on such systems can be especially burdensome if usage is relatively low.Â
Finding a suitable expert partner to assist with your GMP biosafety testing and characterization needs is critical as these tests often form the bottleneck for release of product to patients.Â
OUR QUALITY MISSION STATEMENT
PathoQuest provides fully GMP validated NGS-based testing methods, from sample preparation protocols to actionable reports, including expert bioinformatics analysis, based on ICHQ2R1 guidelines.
We are an active advocate for the decreased use of animal models based on the 3Rs initiative. We provide the tool to not only replace animal testing but to also enhance QC testing.
In November 2021, PathoQuest obtained a GMP certification for biopharmaceutical testing activities at our French-based facilities in Paris (France), following the inspection by the French National Agency for the Safety of Medicine and Health Products (ANSM).
In September 2020, our site in France obtained the administrative authorization of the Pharmaceutical Establishment from the French ANSM for its biological drug testing activities. Additionally, our IT infrastructure and the associated data integrity and security are in compliance with 21 CFR part 11.
As a leader in providing NGS solutions, PathoQuest is part of this global initiative with our senior team being members of groups like Advanced Virus Detection Technologies Interest Group (AVDTIG) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
News & Events
Webinar – Integration Site Analysis: An innovative method for faster, more certain clone selection & genetic stability testing
Integration Site Analysis: An Innovative Method For Faster, More Certain Clone Selection & Genetic Stability TestingThis webinar will provide information on the new integration site analysis assay PathoQuest has launched. The assay uses Cas9 targeted DNA cleavage...
Substitution of in vitro and in vivo virus testing with PathoQuest NGS confirmed by French Agency.
Substitution of in vitro and in vivo virus testing with PathoQuest NGS confirmed by French AgencyPathoQuest is pleased to announce that the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) have recently published their review of PathoQuest’s...
PathoQuest Announces Head-to-Head Study Validating Proprietary Next Generation Sequencing Viral Safety Assay as a Reliable In Vitro Alternative to Animal Testing Methods
PathoQuest Announces Publication of a Head-to-Head Study Validating Proprietary NGS Viral Safety Assay as a Reliable Alternative to Animal Testing NGS assay demonstrated a broader detection range than standard in vivo tests with comparable or higher analytical...
Contact us
U.S.
466 Devon Park Dr
Wayne, PA 19087
United States
E: contact@pathoquest.com
Sign up for our latest news
France
+33Â (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
How can PathoQuest help?
U.S.
466 Devon Park Dr
Wayne, PA 19087
United States
France
+33Â (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
E: contact@pathoquest.com
How can PathoQuest help?
Sign up for our latest news