29/09/2020
PathoQuest obtains Pharmaceutical Establishment status from French ANSM for its biological drug testing activities
Paris, France - September 29, 2020 - PathoQuest, a leader in quality control solutions based on the company’s expertise and use of cutting-edge genomic sequencing technology, announced that it has obtained the administrative authorization of Pharmaceutical Establishment from the French Agence Nationale de Sécurité du Médicament (ANSM) for its biological drug testing activities.
The Pharmaceutical Establishment status granted by the French ANSM acknowledges PathoQuest's efforts to structure and organize its testing activities to meet the high standards of the pharmaceutical industry for the quality control business: analytical robustness, process standardization and compliance with regulations.
“Today we are moving beyond being a technology company to become a true leader in the quality control testing of biologics with a key focus on viral safety and genetic characterization,” stated Violaine Mélen, PharmD, PathoQuest’s Chief Quality Assurance & Regulatory Affairs Officer, Qualified person. “Having pharmaceutical establishment status is a pledge of quality and a key reassurance factor for the health authorities and the biopharmaceutical companies we partner with. It is also a prerequisite for GMP certification, which we are expecting in the near future.”
“Gaining pharmaceutical establishment status is a major milestone in the implementation of PathoQuest’s growth strategy,” commented Jean-Francois Brepson, PathoQuest’s CEO. “It enables the company to accelerate its capabilities to offer large-scale, high-quality, standardized quality control testing for biological drugs using genomic sequencing. PathoQuest's objective is to become a leader in this field while also reducing development and biomanufacturing time for biopharmaceutical and biotech companies worldwide.”
The Pharmaceutical Establishment status granted by the French ANSM acknowledges PathoQuest's efforts to structure and organize its testing activities to meet the high standards of the pharmaceutical industry for the quality control business: analytical robustness, process standardization and compliance with regulations.
“Today we are moving beyond being a technology company to become a true leader in the quality control testing of biologics with a key focus on viral safety and genetic characterization,” stated Violaine Mélen, PharmD, PathoQuest’s Chief Quality Assurance & Regulatory Affairs Officer, Qualified person. “Having pharmaceutical establishment status is a pledge of quality and a key reassurance factor for the health authorities and the biopharmaceutical companies we partner with. It is also a prerequisite for GMP certification, which we are expecting in the near future.”
“Gaining pharmaceutical establishment status is a major milestone in the implementation of PathoQuest’s growth strategy,” commented Jean-Francois Brepson, PathoQuest’s CEO. “It enables the company to accelerate its capabilities to offer large-scale, high-quality, standardized quality control testing for biological drugs using genomic sequencing. PathoQuest's objective is to become a leader in this field while also reducing development and biomanufacturing time for biopharmaceutical and biotech companies worldwide.”
