Merck Millipore Expands Biomanufacturing Sciences and Training Center in Japan and Announces Opening of New Location in Tokyo

• Facility expansion and relocation of existing operations from Yokohama, Kanagawa Prefecture to Tokyo
• New technology support center for biopharmaceutical manufacturing designed to enhance efficiency and speed for development and manufacturing processes

August 26, 2014, Darmstadt, Germany and Tokyo, Japan — Merck Millipore, the Life Science division of Merck, today 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 Merck Millipore.

“We recognize 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 Merck Millipore. “Our goal for this facility, now the ninth of its kind for Merck 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, Merck Millipore’s Biomanufacturing Sciences Training Centers 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 Merck 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 optimization, a Seminar & Training Zone, and a Gallery Zone with displays of Merck Millipore products. Staff members with expert knowledge provide multifaceted support to client companies for biopharmaceutical manufacturing.

Merck 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. Merck Millipore has invested €1.3 million in the project, which will relocate the existing center in Yokohama, Kanagawa Prefecture into a larger facility.

About the Merck Millipore Bioforum 2014
The Merck Millipore Bioforum 2014 will be held on the opening day of the BSTC, September 4, 2014 (Thursday), in Odaiba, Tokyo. This year’s forum, the 13th such event, is entitled “Advanced Technologies in Biopharmaceutical Manufacturing and Future Prospects,” and will feature a presentation by experts in the field of biopharmaceutical manufacturing on solutions utilizing the latest technologies, and the outlook for the industry.

Background

Facility Overview:

• Location: DiverCity Tokyo Office Tower 15F, 1-1-20 Aomi, Koto-ku, Tokyo
• Floor space: 1,074.29m2

Main Facilities

• Pilot Scale Zone
  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.
  
  
• Process Development and Application Test Zone
  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.
  
  
• Seminar & Training Zone
  The Seminar & Training Zone offers a range of certification training and seminars at world-class training facilities (up to 50 persons), taught by Merck 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.
  
  
• Gallery Zone
  The Gallery Zone comprises displays of the latest Merck 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.

About Merck Millipore
Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers’ success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science.

Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 66 countries and 2013 revenues of €2.6 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada.

Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany

About Merck
Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.