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PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.
Contract research organization (CRO), PathoQuest, has received a good manufacturing practice (GMP) certificate for its next-generation sequencing (NGS)-based quality control testing services that it performs at its facility in Paris, France.
According to a Nov. 24, 2021 press release, the GMP certificate was awarded after a recent inspection by the French National Agency for the Safety of Medicine and Health Products (ANSM). The certification makes PathoQuest the first French CRO capable of offering GMP grade NGS-based testing services for quality control of biological drugs.
“Obtaining the GMP certification confirms that our quality management system meets the requirements and is at the expected level by the health authorities,” said Violaine Mélen, PathoQuest’s Chief Quality Assurance & Regulatory Affairs officer, and qualified person, in the press release. “The GMP certification for our biosafety testing services completes our [good laboratory practice] 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 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,” added Jean-Francois Brepson, PathoQuest’s CEO, in the press release. “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 GMP grade. Those assets make PathoQuest the ideal partner.”