Pharmaceutical Establishment Status at PathoQuest
PathoQuest, a leading genomics testing service provider with headquarters in Paris, France, has recently been granted a Pharmaceutical Establishment license from the French National Agency for Medicines and Health Product Safety (ANSM). This licensure indicates that their testing technology and processes meet the pharmaceutical industry’s highest standards for quality control, including analytical robustness, process standardization, and regulatory compliance.
“We can now accelerate our capabilities to offer large-scale, high-quality, standardized quality control testing for biological drugs using genomic sequencing,” said Jean-François Brepson, PathoQuest’s CEO. Anticipating an upcoming regulatory audit, PathoQuest now awaits an audit for GMP certification.
Charles River is pleased to support PathoQuest’s growth in expanding the opportunities to soon serve a greater number of biotech companies with GMP testing that accelerates development and manufacturing. PathoQuest’s in vitro platform leverages a proprietary sample preparation process, pathogen genome sequencing database, and automated analysis pipeline in assays that secure the safety of your biologic and advanced therapy medicinal products (ATMPs), such as cellular and gene therapies.
The platform’s next generation sequencing (NGS) assays offer a high-throughput supplement or replacement for traditional testing. Focused on risk management, the genomics-based assays are highly specific and sensitive, delivering fast, unambiguous results. With NGS quality control, you can ensure the safe, timely delivery of your products.