Evry, September 16th, 2008 – GenoSafe® SAS (the Genopole Evry-based service company specializing in evaluation of the safety and efficacy of innovative biotherapeutic products) has just obtained good laboratory practice (GLP) certification from the French Agency for Healthcare Products Safety (AFSSAPS)An essential guarantee of quality and safety
The principles behind GLP constitute an organisational framework that covers all aspects of the planning and execution of non-clinical safety trials. Ever since GenoSafe's incorporation, customer-initiated preclinical studies have represented an ever-increasing proportion of the company's business. Following the inspection of GenoSafe's installations and an audit of its studies, the AFSSAPS has awarded the company with a GLP compliance certificate. GenoSafe obtained "A grade" compliance from the French regulatory authority in the "drugs for human use" category. GLP certification is a significant step forward for GenoSafe and will enable it to provide its customers with an internationally acknowledged guarantee of the quality, reproducibility and integrity of the regulatory data that the company generates. The certification will help GenoSafe meet its customers' needs and should attract new business in the field of GLP-compliant product safety evaluation...
... GenoSafe: From the initial steps in lab research to clinical trials, GenoSafe (a biotech company based on the Genopole Evry biopark, just south of Paris) has unique expertise in the development, validation and implementation of analytical methods for evaluating the safety and efficacy of biotherapeutic products such as gene and cell therapy products, vaccines, recombinan proteins and monoclonal antibodies. GenoSafe provides advice and project support to its customers (biotech firms, pharmaceutical companies, academic labs and research institutes) by offering them a broad range of services in complementary fields: molecular analysis (personalized qPCR, RT-qPCR and biodistribution studies), immunomonitoring, the quality control of viral vector batches and the creation and verification of custom cell lines... [PDF] GenoSafe's Press Release - PDF du Communiqué de Presse GenoSafe -
