SGS Life Science Services' 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 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; SGS has a GMP Life Science Services laboratory in Clichy, located in the Paris suburbs. The Clichy laboratory has extensive experience in analytical development supporting the quality control testing of traditional, small molecule drugs, while the Poitiers site will undertake the dedicated testing of biopharmaceutical products. According to the company, by offering biological testing under GMP, the expertise in cell-based assays and immunoassays from the Poitiers team can complement 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.”