- Commercial long-term deal with a large pharmaceutical company pursuing manufacturing and commercial regulatory approvals in major markets
- Customer commits to AGC Biologics’ new site in Yokohama for five commercial biologics programs
- Highlights growing demand for geopolitically stable supply chains, positioning Japan as an allied hub for global supply of biopharmaceuticals
YOKOHAMA, JAPAN – July 28, 2026 – Ahead of the official opening of AGC Biologics’ Yokohama site, an international biopharmaceutical company has already secured half of the facility’s mammalian manufacturing capacity with a multi-year commercial contract expected to reach hundreds of millions of dollars in total value. The Contract Development and Manufacturing Organization (CDMO) will leverage its new Yokohama facility to manufacture a minimum of 35 batches per year of five biopharmaceutical products for the undisclosed customer, securing a reliable global supply chain for patients worldwide.
The agreement includes process transfer, scale-up, regulatory validation, and future commercial production. The customer will pursue multiple regulatory approvals with the EMA, FDA, MHRA, and PMDA. The aggressive manufacturing timeline includes four process performance qualifications (PPQ) campaigns in the first two years.
Securing commercial production in Japan reflects a broader industry shift toward supply chain resilience, as global biopharmaceutical developers increasingly prioritize established, geopolitically stable manufacturing partners with locations that mitigate geopolitical, regulatory and trade risks.
“AGC Biologics has the largest global network of single-use manufacturing capacity by volume outside of China, but that’s not the full story,” said Alberto Santagostino, President and CEO of AGC Biologics. “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. Our newest Japan site in Yokohama synthesizes all our network learning in a location of increasing interest, and that carries the intrinsic cultural value of manufacturing quality and effective delivery.”
Once operational in 2027, the Yokohama site will deploy four 2,000-liter Cytiva single-use bioreactors and two 5,000-liter Thermo Fisher Scientific DynaDrive single-use bioreactors, adding 18,000 liters to AGC Biologics’ existing capacity of single-use technology for biologics manufacturing. Select customers and guests are scheduled to be provided with the opportunity to visit the new site in December 2026, when construction is completed.
“Securing a major commercial partner for Yokohama before the site is operational is a strong signal of confidence in what this facility will offer,” said Tadashi Murano, President of AGC Life Science Company. “With the site located adjacent to the AGC Yokohama Technical Center, biopharmaceutical developers are understanding that choosing a CDMO with an established innovation ecosystem in Japan is a smart outsourcing strategy.”
The AGC Biologics’ Yokohama site was part of the biomanufacturing investments made by Japan’s Ministry of Economy, Trade and Industry in 2022. These strategic investments are designed to expand domestic production and reinforce Japan’s position as a highly trusted, long-term biologics partner for life sciences industries within allied nations.
Services available in Yokohama starting in 2027 will include:
- Mammalian development and GMP manufacturing, with two downstream lines and flexible single-use bag capacity of 18,000 liters.
- Cell therapy services with six clean rooms.
- Messenger RNA (mRNA) development and manufacturing with 2 IVT, two purification lines, and two LNP lines.
- More than three decades of GMP experience.
- 100 successful regulatory inspections.
- More than 30 commercial products launched, which received more than 100 separate regulatory agency approvals.
- More than 400 products developed and manufactured for over 250 different customers.
With existing cGMP manufacturing locations in the U.S., Japan, and Europe, AGC Biologics’ track record will help kick off the manufacturing operation in Yokohama, utilizing the experience of:
- More than three decades of GMP experience.
- 100 successful regulatory inspections.
- More than 30 commercial products launched, which received more than 100 separate regulatory agency approvals.
- More than 400 products developed and manufactured for over 250 different customers.
