SGS Life Science Services announced today that its bioanalytical laboratory in Poitiers, France has received GMP (Good Manufacturing Practices) certification, following approval from the Agence Nationale de Sécurité du Médicaments et des Produits de Santé (ANSM), the French agency charged with ensuring the quality of drug products. With this GMP certification, the Poitiers laboratory can now provide tests required for final batch release.
The GMP services will be performed in dedicated suites and controlled access areas of approximately 200 square meters, with room for future expansion. The Poitiers facility has been operating under GLP since 1994 and SGS capitalizes on its knowledge of GMP from its Life Science Services laboratory in Clichy, located in the Paris suburbs. Between these two sites in France, SGS can offer a complete range of services covering GMP activities from small to large molecules. The Clichy laboratory has extensive experience in analytical development supporting the quality control testing of traditional, small molecule drugs, whereas the Poitiers site will undertake the dedicated testing of biopharmaceutical products. Furthermore, by offering biological testing under GMP, the expertise in cell-based assays and immunoassays from the Poitiers team complements SGS M-Scan laboratories to support the characterization, lot release and stability testing of biologics.
“This serves as yet another example whereby SGS replicates the expertise at one site and brings it to another. ” said Anne Hays, Executive Vice President, SGS Life Science Services. “Bringing GMP to the Poitiers site allows us to offer cell-based assays for the testing of biologics, with some of the initial projects coming from companies developing biosimilars. Furthermore, SGS has plans to bring bioanalytical capability to the West Coast of North America with the development of a new facility in Carson, California.”
With 20 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV) and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.
Global Marketing Director
Life Science Services
SGS, 75 Passaic Avenue, Fairfield, NJ 07004, USA
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.