- EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre in Martillac, France
Product News: EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre in Martillac, France
EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, today announced that its Biodevelopment Centre in Martillac, France, has been recertified by the French National Agency for Medicines and Health Products Safety (ANSM), the competent authority of France.
The certification confirms the 3440-square-meter facility complies with the principles of Good Manufacturing Practice (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 1250L stainless steel suite.
EMD Millipore's Provantage® biodevelopment and clinical supply services are delivered at the Martillac, France facility. This innovative approach for biologics manufacturing incorporates the latest 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.
"We are proud to be one of the first facilities to attain GMP compliance utilizing single-use equipment for each unit operation from upstream through downstream. This recertification reflects the teamwork and dedication of our entire staff and provides our customers with complete confidence in our technical expertise and quality," notes Richard Pearce, Business and Operations Director of the Biodevelopment Centre.