Training speeds up production
Merck KGaA, Darmstadt, Germany, gets even closer to its customers in Japan
Since 2000, the Life Science business of Merck KGaA, Darmstadt, Germany, has been setting up centers for process development, technology support and training all over the world for its customers from the pharmaceutical and biotechnology sectors. At these state-of-the-art centers, the customers receive expert support as they partner with the company's engineers and scientists to create the most efficient processes for biopharmaceutical manufacturing. The Biomanufacturing Sciences and Training Center has been setting benchmarks in Tokyo since September 2014.
Takao Ito, Senior Manager of the Biomanufacturing Sciences Network
© Merck KGaA, Darmstadt, Germany
Bright colors, futuristic design and a location above a hip shopping center on an artificial island near Tokyo — at first glance, all of these elements resemble the flagship stores of fashion companies and computer manufacturers. But sneakers and smartphones have nothing to do with the Biomanufacturing Sciences and Training Center (BSTC), recently built by the Life Science business of Merck KGaA, Darmstadt, Germany
, at a cost of € 1.3 million. That is because the center is a place where experts from the pharmaceutical industry – both current and future customers – can test and assess products. This central Tokyo location was specifically selected to ensure close proximity to customers, as well as easy access. In this vibrant center, visitors receive exactly the kind of support they need for optimizing the development and production processes of their biopharmaceutical products. “In the first quarter since we opened in September 2014, hundreds of customers have already used our services,” says Takao Ito, the Senior Manager of the Biomanufacturing Sciences Network, with a smile.
Creating global connections
“At the Biomanufacturing Sciences and Training Center we simulate a real manufacturing environment that enables customers to cooperate with experts from Merck KGaA, Darmstadt, Germany, to evaluate processes and conduct training courses,” Ito continues. Since 2000, the company has set up similar centers in eight other regions — the United States, Germany, France, China, South Korea, Singapore, India, and Brazil – all located close to the company's customers. “We know our customers are under great pressure to reduce development costs and increase production efficiency,” Ito says. “These centers have been created to help our customers address these needs.”
“At the BSTC we reduce the amount of time needed to create new processes.“
For example, these centers support customers’ efforts to speed up their drug development processes. System solutions from Merck KGaA, Darmstadt, Germany, such as the Mobius® series, can be configured to the requirements of the customer’s production processes. Practically all of the products that are relevant to development and production can be evaluated here live, so to speak. For instance, visitors can prepare and test buffer solutions and media for cell cultures, assess chromatographic processes, and receive training in virus filtration, ultrafiltration, and sterile filtration processes. In addition, at the BSTC they can test the scaling-up of laboratory processes to production dimensions. And lastly, the company provides the training for the engineers and operators who will manage the new production process later on. “This reduces the amount of time our customers need to implement a new process, thereby ultimately allowing companies to bring their drugs to market faster,” says Ito.
Simulation makes processes more efficient
In Tokyo, local Biomanufacturing Sciences Network employees, in cooperation with other technical experts from the global company team, support the biopharmaceutical and biotechnology customers working at the center. Simulations help these customers to implement systems more effectively and design production processes more efficiently in accordance with guidelines such as Current Good Manufacturing Practice – CGMP. “This helps to reduce the risks that are often associated with the introduction of new systems,” Ito explains.
Stylish and modern: The BSTC in Tokyo resembles a showroom of a fashion company or a computer manufacturer
© Merck KGaA, Darmstadt, Germany
The Tokyo BSTC consists of four zones: the pilot phase zone, the process development and application testing zone, a seminar and training zone, and the interactive area. In the pilot phase zone, processes can be simulated in practice-oriented ways. This zone is equipped with disposable components from the Mobius® series for cultivation, filtration, and purification. This makes it possible to test entire bioprocess systems — on the same scale as the actual production processes. That includes buffering, media preparation, mixing, cell culture, clarifying filtration, chromatography, virus removal, concentration, buffer exchange, and sterile filtration. The zone is also used as a demonstration area, and it offers the possibility of validating new systems, developing protocols, and analyzing methods. Training sessions can also be conducted here.
The process development and application testing zone is a laboratory area where various experimental procedures can be carried out on a small scale. This supports process development and the definition of optimal operating conditions. Practice-oriented training sessions help customers solve a variety of validation problems and technical challenges. In the seminar and training zone with its state-of-the-art equipment, it is possible to offer certification courses and seminars for up to 50 people. The courses are conducted by experts from Merck KGaA, Darmstadt, Germany, or by external instructors. The training sessions include theoretical courses, group discussions, and practical laboratory courses.
A good work-life balance
The display zone presents the most important products manufactured by Merck KGaA, Darmstadt, Germany, including cell culture media, raw materials for pharmaceutical production processes, systems for sterile filtration, tangential flow filtration units, various types of virus filters, chromatographic fillers, and sterile liquid feed units.
In these ways, customers receive extensive support at the BSTC — in a professional and attractive environment. And after the visitors have successfully finished their work, they can relax in the DiverCity Tokyo Plaza shopping center, which is located directly across from the BSTC. Here they can find a wide range of restaurants and entertainment options, such as the life-size Gundam robot from the Japanese science-fiction universe of one of the animated film series that are known in Japan as anime.