AGC Bio nabs manufacturing deal for Japan site worth hundreds of millions

The long-term agreement announced by the CDMO reserves half of its Yokohama facility’s mammalian manufacturing capacity for five commercial biologics programs.

AGC Biologics, a contract development and manufacturing organization (CDMO) headquartered in Seattle, has signed a long-term commercial manufacturing agreement with an undisclosed pharmaceutical company that will utilize approximately half of the mammalian manufacturing capacity at its new Yokohama, Japan facility.

Under the agreement, reportedly worth hundreds of millions of dollars, AGC Biologics will provide process transfer, scale-up, regulatory validation, and commercial manufacturing for five biologic products. According to the company, the facility will manufacture a minimum of 35 commercial batches annually, with the customer planning to seek regulatory approvals from the U.S. Food and Drug Administration, European Medicines Agency, UK’s Medicines and Healthcare products Regulatory Agency, and Japan’s Pharmaceuticals and Medical Devices Agency.

The Yokohama facility, which is scheduled to begin operations in 2027, will add 18,000 liters of single-use bioreactor capacity to AGC Biologics’ global manufacturing network. The site will also provide mammalian biologics manufacturing, cell therapy manufacturing, and messenger RNA (mRNA) development and manufacturing services.

According to the announcement, the project was supported by Japan’s Ministry of Economy, Trade, and Industry as part of a national initiative to expand domestic biomanufacturing capacity and strengthen supply chain resilience. AGC Biologics said securing a commercial customer before the facility becomes operational reflects growing demand for geographically diversified manufacturing networks.

The announcement follows AGC Biologics’ recent collaboration with Pyramid Pharma Services to expand its U.S.-based fill-finish capabilities. According to the company, the partnership integrates biologic drug substance manufacturing with sterile fill-finish services, including vial filling, prefilled syringes, and cartridges, to reduce manufacturing handoffs and provide a more streamlined path from development through commercial supply.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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