PATHOQUEST
24.11.2021 13:02:07 CET | Business Wire | Press release
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211124005881/en/
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.
About PathoQuest
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.
For more information, visit www.pathoquest.com or contact us at welcome@pathoquest.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20211124005881/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Enhertu® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 14:00:00 CEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority
Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 13:45:00 CEST | Press release
Global teams recognised in the Future Health Challenge for solutions designed to detect health risks earlier and support faster health system decisions Future Health – A Global Initiative by Abu Dhabi and MIT Solve announce the winners of the inaugural Future Health ChallengeWinning solution equips frontline health workers in low-resource settings with mobile clinical decision-support tools, enabling earlier detection and more effective care deliveryTeams competed for a USD 200,000 grand prize and two USD 50,000 runner-up awards on the sidelines of the 79th World Health Assembly in GenevaWinners recognised for solutions advancing anticipatory, data-driven health systems Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, s
Pivotal Trial Data for EP0031 (A400), a Next-Generation Selective RET Inhibitor (SRI), in RET Positive Advanced NSCLC, to be Presented at ASCO 202622.5.2026 11:18:00 CEST | Press release
Ellipses Pharma (“Ellipses”), a global oncology drug development company with a pipeline of innovative programmes, announced today that its partner, Kelun-Biotech, is presenting pivotal trial data for EP0031/A400, for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC), at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting Chicago, May 29 to June 2. Efficacy and safety of lunbotinib (A400/EP0031), a next-generation selective RET inhibitor (SRI), from a pivotal phase Ⅱ study in patients with advanced RET-fusion positive non-small cell lung cancer (NSCLC), will be presented as an oral presentation scheduled on May 29, 2026, 14:36-14:48 local time (Abstract #8505: Lung Cancer – Non-Small Cell Metastatic). The oral presentation of these data at the prestigious ASCO annual meeting, represents another major milestone in the global development of EP0031/A400 as a next generation SRI. The data were generated in Kelun-Biotech’s Phase 2 study (NCT0
FPT Launches Flezi Foundry™, Advancing AI-Augmented Delivery for Global Enterprises22.5.2026 10:11:00 CEST | Press release
Global IT corporation FPT announced the launch of Flezi Foundry™ (FPT Digital Foundry™), an AI-augmented delivery platform for software development and IT operations. Built around a governed Service-as-a-Software model, the platform combines autonomous AI agents, human expert oversight, secure infrastructure, and outcome-based delivery mechanisms to help enterprises modernize technology delivery as AI agents become part of software engineering and IT operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521235556/en/ Flezi Foundry applies Agentic Engineering, a structured delivery approach for software development and IT operations. The model brings AI agents into delivery workflows with human supervision, governance, transparency, and performance measurement built into the process. Flezi Foundry operates through two service modes: Agentic Development Lifecycle (ADLC) supports software development by using specialize
Boomi Named One of The Sunday Times Best Places to Work 202622.5.2026 08:00:00 CEST | Press release
Employee-led recognition places Boomi among the UK's top medium-sized employers, with a flight risk of just 3% against a technology sector average of 42% Boomi achieves an average employee happiness score of 86%, rated Excellent across all six dimensions of WorkL's workplace framework Flight risk of just 3%, compared to a technology sector average of 42%, reflecting exceptional levels of employee loyalty Rated Excellent for Diversity and Inclusion and Confidence in Management Boomi, the data activation company for AI, has today been named one of The Sunday Times Best Places to Work 2026 in the Medium Organisation category. The prestigious annual list, produced by The Sunday Times in partnership with global workplace analytics company WorkL, recognises the UK's finest employers based entirely on direct employee feedback, making it one of the most credible and transparent employer benchmarks in the country. This press release features multimedia. View the full release here: https://www.b
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom