EMD Millipore reported that its Biodevelopment Centre in Martillac, France, has been recertified by the French National Agency for Medicines and Health Products Safety, the competent authority of France. The certification confirms the 3440 m2 facility complies with the principles of GMP for active substances. The audit included a thorough review of quality systems, supplier management, control of raw materials, documentation, calibration and validation. Prior certification consisted only of stainless steel equipment, while this recertification included complete single-use upstream and downstream suites, as well as a 2 x 1250 L stainless steel suite.
EMD Millipore's Provantage biodevelopment and clinical supply services are delivered at the Martillac, France facility. This approach for biologics manufacturing incorporates technologies in upstream, downstream and single-use systems. This Provantage offering includes process development and GMP drug substance for pre-clinical to Phase II and is available to a global customer base.