AGC Biologics Boosts Single-Use Capacity at New Yokohama Site

AGC Biologics Boosts Single-Use Capacity at New Yokohama Site

AGC Biologics, a leading global Contract Development and Manufacturing Organization (CDMO), has announced a pivotal strategic move aimed at reinforcing its commitment to innovative single-use technologies. The company revealed that it will be incorporating two state-of-the-art 5,000-liter Thermo Scientific DynaDrive Single-Use Bioreactors (S.U.B.s) into its new facility located in Yokohama, Japan. This development will transform the site into one of the most advanced large-scale mammalian biologics manufacturing facilities in Japan, with full GMP operations expected to begin in 2027.

This strategic investment aligns with the CDMO’s broader vision to remain at the forefront of biopharmaceutical manufacturing by expanding its use of single-use systems, which have become an industry standard in mammalian cell culture processes. According to the 2024 BDO Group’s bioTRAK Database, single-use technologies now account for over half—51 percent—of all mammalian bioreactor technology worldwide, surpassing traditional stainless steel systems. The adoption of this trend is driven by several key advantages, including reduced cleaning requirements, lower initial infrastructure costs, faster setup times, greater operational flexibility, scalability for fluctuating product demands, and shortened clinical production timelines.

AGC Biologics already boasts one of the industry’s largest single-use manufacturing capacities, ranking second globally in total volume, as reported by bioTRAK. The addition of the Yokohama facility strengthens this position, allowing the company to offer an even more robust and flexible network for customers worldwide. The deployment of Thermo Scientific’s advanced bioreactors is expected to ensure that AGC Biologics remains well-positioned to meet the rising demand for high-performance single-use technologies.

“The new Yokohama site is designed to utilize single-use bioreactors to offer large-scale GMP manufacturing. The cutting-edge technology from Thermo Scientific makes this one of the most advanced sites in Japan for large-scale manufacturing and further expands our robust global network of single-use manufacturing sites on three continents,” said Christoph Winterhalter, Chief Business Officer at AGC Biologics. “This location offers the capabilities to meet the commercial needs of customers in Japan and Asia, as well as global customers seeking capacity using the latest technology.”

Single-use technologies provide CDMOs with the flexibility to accommodate a wide range of client needs, including the capability to scale up or down based on project requirements. In the case of the DynaDrive 5,000L S.U.B.s, their high-performance design enables seamless scalability and superior process intensification capabilities. These features not only help reduce operational costs but also enhance the efficiency and yield of bioproduction processes.

“Flexibility and the means to scale production cost-effectively is key for any developer of therapies today, and CDMOs need the best technology possible to help them accomplish that. The DynaDrive 5,000 L Single-Use Bioreactor delivers seamless scalability, exceptional flexibility, and superior process intensification capabilities – embodying best-in-class performance. AGC Biologics’ new site in Yokohama will be a premier site in Japan for large-scale single-use technology thanks to our collaboration,” stated Daniella Cramp, Senior Vice President and President of Thermo Fisher Scientific’s Bioproduction business.

Once operational, the Yokohama facility will support a comprehensive suite of biopharmaceutical development and manufacturing services. These will span from early-phase process development to late-phase and commercial production. The site is being developed to handle a broad spectrum of advanced modalities, including mammalian expression systems, cell therapies, and mRNA-based drug products. This comprehensive service offering is intended to provide clients with end-to-end support across their product development lifecycle.

Importantly, the Yokohama site is expected to play a critical role in enhancing operational and supply chain efficiencies across AGC Biologics’ global manufacturing network. With this addition, the company now extends its footprint in the Asia-Pacific region, complementing its existing facility in Chiba, Japan. The Chiba site currently offers mammalian expression and microbial fermentation capabilities, and the introduction of the Yokohama facility will help balance workloads while increasing capacity for high-demand projects.

The new site also aligns with AGC Biologics’ sustainability initiatives by utilizing single-use systems that significantly reduce water and chemical consumption associated with traditional clean-in-place (CIP) and steam-in-place (SIP) procedures. The DynaDrive technology is specifically engineered to deliver high performance while minimizing environmental impact, a growing concern in the biomanufacturing sector.

The strategic placement of the Yokohama site is no accident. Located in one of Japan’s most vibrant innovation hubs, the facility is expected to tap into a deep pool of scientific talent and foster collaborations with local academic institutions and biotech firms. This environment is conducive to innovation and supports AGC Biologics’ commitment to delivering high-quality biopharmaceutical solutions.

AGC Biologics is part of AGC Inc.’s Life Science Company, which operates more than ten facilities worldwide focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients (APIs), and agrochemicals. This global network is designed to provide customers with the reliability and flexibility they need to bring life-saving treatments to market.

Through its continuous investment in state-of-the-art infrastructure and cutting-edge technologies, AGC Biologics is reinforcing its role as a strategic partner in the biopharmaceutical industry. By expanding its global single-use technology footprint, the company is ensuring that it can meet the evolving needs of its clients in an increasingly complex and competitive market.

In conclusion, the integration of Thermo Scientific’s 5,000L DynaDrive S.U.B.s into AGC Biologics’ new Yokohama facility marks a significant milestone in the company’s growth trajectory. This move not only enhances AGC’s technological capabilities but also solidifies its leadership in single-use biomanufacturing solutions. With the global demand for flexible, scalable, and cost-effective biologics manufacturing continuing to rise, AGC Biologics is well-positioned to help its clients navigate the path from development to commercialization successfully.

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