New CDMO site introducing the most advanced and large-scale single-use bioreactors in Japan

AGC announced a strategic decision about the large-scale single-use technology it will use at its new Yokohama, Japan facility. The CDMO is introducing two 5,000 L Thermo Scientific DynaDrive Single-Use Bioreactors (S.U.B.), which makes the site one of the most advanced in Japan for large-scale mammalian-based biologics production, with GMP operations beginning 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 the traditional stainless-steel alternative. Attributes driving this trend include fewer cleaning requirements, lower cost barrier to entry and timeline for setup, flexible configurations, scalability to meet changing product demands, and shorter clinical production timelines. AGC Biologics has the second largest global network of single-use manufacturing capacity by volume in the industry, according to bioTRAK. The new bioreactor technology ensures the company stays ahead of industry-wide demand for single-use systems.

"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. “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.”

"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," said Daniella Cramp, Senior Vice President and President of Thermo Fisher Scientific’s Bioproduction business.

The new AGC Biologics Yokohama facility will offer support from initial process development work for early-phase projects to late-phase and commercial production. It will support mammalian expression, cell therapy, and messenger RNA (mRNA) drug products.

By adding another site in the region, the Yokohama facility is expected to help maximize operational and supply chain efficiencies across AGC Biologics' global network. The CDMO currently operates one site in Japan, its Chiba facility, which offers mammalian expression and microbial fermentation services.  

AGC Biologics is a part of AGC Inc.'s Life Science Company. The Life Science company operates over 10 facilities worldwide focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals