AGC Biologics is significantly expanding its global cell therapy capabilities with the launch of development and clinical manufacturing services at its Yokohama Technical Center starting July 1, 2025, while simultaneously introducing cutting-edge single-use bioreactor technology at its new Yokohama manufacturing facility scheduled for 2027 operations.
Strategic Expansion of Cell Therapy Operations
The new Yokohama site marks a pivotal expansion for AGC Biologics' Global Cell and Gene Technologies Division, establishing cell therapy manufacturing capabilities across three continents - Milan, Italy; Longmont, Colorado, US; and now Yokohama, Japan. This geographical diversification enables the company to better serve customers requiring both autologous and allogeneic products across global markets.
The Yokohama location will provide comprehensive process transfer and manufacturing services for pre-clinical and clinical trials, targeting the expanding global cell therapy market. Core technologies at the facility include induced pluripotent stem cells, mesenchymal stem cells, hematopoietic stem cells, and CAR-T cell therapies.
Advanced Single-Use Bioreactor Technology
AGC Biologics has made a strategic decision to implement two 5,000 L Thermo Scientific DynaDrive Single-Use Bioreactors at its new Yokohama manufacturing facility, positioning the site as one of the most advanced in Japan for large-scale mammalian-based biologics production. GMP operations are scheduled to begin in 2027.
According to 2024 data from BDO Group's bioTRAK Database, single-use technology represents 51 percent of all mammalian bioreactor technology globally, outpacing traditional stainless-steel alternatives. The technology's advantages include fewer cleaning requirements, lower cost barriers to entry, faster setup timelines, flexible configurations, scalability to meet changing product demands, and shorter clinical production timelines.
"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, AGC Biologics.
Industry-Leading Manufacturing Network
AGC Biologics maintains the second largest global network of single-use manufacturing capacity by volume in the industry, according to bioTRAK data. The new bioreactor technology ensures the company stays ahead of industry-wide demand for single-use systems.
Daniella Cramp, Senior Vice President and President of Thermo Fisher Scientific's Bioproduction business, emphasized the technology's capabilities: "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."
Comprehensive Service Portfolio
The new AGC Biologics Yokohama facility will offer comprehensive support from initial process development work for early-phase projects to late-phase and commercial production. The facility will support mammalian expression, cell therapy, and messenger RNA (mRNA) drug products.
The Milan-based AGC Biologics Cell and Gene Technology Center of Excellence, with its nine product approvals by the EMA and FDA, hundreds of batches manufactured, and 30-year track record, will support and enable the successful ramp-up of operations at the new Yokohama site.
The AGC Inc. Yokohama Technical Center, built in 2020, is dedicated to advancing AGC Inc.'s research and development capabilities in materials science, chemical processes, and biotechnology, providing a strong foundation for the expanded operations.
