EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, announced the opening of a new Biomanufacturing Sciences Training Center (BSTC) facility in Tokyo. The state-of-the-art facility is designed to help biopharmaceutical companies develop manufacturing processes and find solutions to processing challenges in collaboration with engineers from EMD Millipore.
“We recognise that our customers in Japan face tremendous pressure to reduce development costs and identify production efficiencies. The new BSTC is designed to recreate an actual manufacturing environment allowing customers to operate equipment, evaluate processes and conduct training,” said Udit Batra, president and chief executive officer of EMD Millipore. “Our goal for this facility, now the ninth of its kind for EMD Millipore, is to enhance the customer experience by delivering innovation, quality products, and comprehensive technological support all major components of our product and service portfolio offering.”
Through the simulation of manufacturing process with leading-edge products, EMD Millipore’s Biomanufacturing Sciences Training Centres allow customers to test equipment and devices, evaluate manufacturing processes, and conduct operator training. This extensive training helps biopharmaceutical companies expedite system implementation and enhances the efficiency of manufacturing process development, while also providing quality assurance validations compliant with GMP standards and various regulations, thus lowering the risk when introducing new systems.
The new facility in Japan comprises a Pilot Scale Zone equipped with EMD Millipore’s Mobius series of single-use components for everything from culture to filtration and purification, allowing for total demonstration testing from upstream to downstream processes. There is also a Process Development and Application Test Zone for various types of testing for process development and optimisation, a Seminar & Training Zone, and a Gallery Zone with displays of EMD Millipore products. Staff membrs with expert knowledge provide multifaceted support to client companies for biopharmaceutical manufacturing.
EMD Millipore has BSTC facilities in nine major regions including Japan, U.S., Germany, France, Singapore, China, South Korea, India, and Brazil. These centers provide universal instruction to partners around the world, allowing clients to receive the same training in any region, even if they move their manufacturing process to other countries. EMD Millipore has invested €1.3 million in the project, which will relocate the existing center in Yokohama, Kanagawa Prefecture into a larger facility.
The Pilot Scale Zone is a testing facility that closely recreates processes, equipped with the latest Mobius series of single-use components for all processes from cultivation to purification. Clients are able to operate and evaluate bioprocess systems on the same scale as actual manufacturing processes, from buffer and media preparation, mixing, to cell culture, clarification, chromatography, viral clearance, concentration and buffer exchange (ultrafiltration), and sterile filtration. The area also provides for demonstrations and validation testing to verify the complex requirements when introducing systems, as well as product protocol development and method analysis, and operator training for technology transfers.
The Process Development and Application Test Zone is a laboratory area for various types of small-scale testing, such as process development, and determination of optimal operating conditions. A wide range of support is provided, including practical training to handle the various problems that occur in validation or engineering.
The Seminar & Training Zone offers a range of certification training and seminars at world-class training facilities (up to 50 persons), taught by EMD Millipore specialists or outside instructors with extensive skills and expert knowledge combined with production floor experience. The hands-on trainings include theory, group discussions, and laboratory practice, providing the latest content reflecting actual process requirements.
The Gallery Zone comprises displays of the latest EMD Millipore products, including cell culture mediums, raw material for pharmaceutical manufacturing, sterile filtration systems, tangential flow filtration systems, various types of viral removal filters, chromatography fillers, and sterile liquid feed connectors.