- AGC Biologics has secured a multi-year commercial manufacturing agreement expected to reach hundreds of millions of dollars in total value, reserving half of the mammalian manufacturing capacity at its new Yokohama facility.
- The agreement covers process transfer, scale-up, regulatory validation, and commercial production of five biopharmaceutical products, with the Yokohama site scheduled to begin operations in 2027.
AGC Biologics has secured a multi-year commercial manufacturing agreement with an undisclosed international biopharmaceutical company ahead of the official opening of its Yokohama facility in Japan. Under the agreement, the biologics CDMO will dedicate half of the site’s mammalian manufacturing capacity to produce a minimum of 35 batches annually across five biopharmaceutical products. The contract is expected to reach hundreds of millions of dollars in total value and supports the companies’ contract manufacturing activities for global supply.
The agreement includes process transfer, scale-up, regulatory validation, and future commercial production. The customer plans to pursue regulatory approvals with the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The manufacturing timeline also includes four process performance qualification (PPQ) campaigns during the first two years.
The Yokohama facility is scheduled to become operational in 2027 and will include four 2,000-liter Cytiva single-use bioreactors and two 5,000-liter Thermo Fisher Scientific DynaDrive single-use bioreactors, adding 18,000 liters of single-use manufacturing capacity. Services will include mammalian development and GMP manufacturing, cell therapy services, and messenger RNA (mRNA) development and manufacturing. Construction is expected to be completed in December 2026, when selected customers and guests will have the opportunity to visit the site.
“The market is demanding capable, reliable manufacturing partners with global quality standards and geographic flexibility. This agreement reflects the strength of our network, our single-use expertise, and the strategic role Japan can play in resilient biologics supply chains.”
Alberto Santagostino, President and CEO of AGC Biologics
The Yokohama site is part of biomanufacturing investments made by Japan’s Ministry of Economy, Trade and Industry in 2022 to expand domestic production and strengthen the country’s biologics manufacturing capabilities. According to AGC Biologics, the new facility will build on its existing global manufacturing network in the U.S., Japan, and Europe, which includes more than three decades of GMP experience, 100 successful regulatory inspections, more than 30 commercial product launches, and development and manufacturing support for more than 400 products across over 250 customers.
