• Reached a long-term business cooperation with a large pharmaceutical company to help it promote production licensing and commercial supervision and approval in major markets.
• Customers choose AGC Biologics Yokohama's new base to promote five commercial biological agent projects.
• Highlight the market's growing demand for geopolitically stable supply chains, while promoting Japan to become a strategic hub in the global biopharmaceutical supply system.
  
  

On the eve of the official opening of the AGC Biologics Yokohama base, an international biopharmaceutical company has locked half of the mammals in the base through a multi-year commercial contract. Cell production capacity, the total value of this contract is expected to reach hundreds of millions of dollars. The contract development and production organization (CDMO) will rely on its new Yokohama production base to produce five biopharmaceutical products for customers whose names have not been disclosed, no less than 35 batches per year, so as to ensure that patients around the world receive reliable supply chain support.

The agreement covers process transfer, amplification, regulatory verification and future commercial production. The customer will promote multiple regulatory approvals from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the UK Drug and Health Products Authority (MHRA) and the Japan Pharmaceuticals and Medical Devices Organization (PMDA). The rapid production plan will carry out four rounds of process performance confirmation (PPQ) activities in the first two years.

The realization of commercial production in Japan reflects the broader trend of the industry's transformation to improve the resilience of the supply chain. As global biopharmaceutical developers increasingly give priority to mature and geopolitically stable production partners, production bases that can reduce geopolitical, regulatory and trade risks are receiving more attention.

Alberto Santagostino, president and CEO of AGC Biologics, said: "AGC Biologics has the largest global disposable capacity network outside China, but this is not all our advantages. The market needs capable and reliable production partners with global quality standards and geographical flexibility. This agreement fully reflects the strength of our global network, our professional capabilities in the field of disposable technology, and the strategic role that Japan can play in building a more resilient biodrug supply chain. Our newly completed base in Yokohama, Japan, brings together the experience and practice accumulated by the global network. It is located in an area that is increasingly concerned. At the same time, it inherits the emphasis on quality and efficient delivery in Japanese manufacturing culture.

The Yokohama base is expected to be put into operation in 2027, when it will be equipped with four sets of 2,000-liter Cytiva disposable bioreactors and two sets of 5,000-liter Thermo Fisher Scientific DynaDrive at a time. The sex bioreactor makes AGC Biologics' production capacity of biological products based on disposable technology add 18,000 liters on the existing basis. Some customers and guests plan to visit the new base after the project construction is completed in December 2026.

Murano Tadashi, president of AGC Life Science Company, said: "The determination of an important business partner for the Yokohama base before the base was put into operation fully reflects the market's confidence in the future value and capabilities of the facility. The base is adjacent to the AGC Yokohama Technology Center, which makes biopharmaceutical developers gradually realize that choosing a CDMO with a mature and innovative ecosystem in Japan is a wise choice for outsourcing.

AGC Biologics Yokohama Base is affiliated with the Ministry of Economy, Trade and Industry of Japan's 2022 Biomanufacturing Investment Plan. These strategic investments aim to expand domestic production capacity and further strengthen its position as a trusted long-term biological agent partner in the life science industry of allied countries.

The services provided by the Yokohama base from 2027 include:

• Mammal cell development and GMP production: equipped with two downstream production lines and a flexible production capacity of 18,000 liter disposable bags.
• Cell therapy service: equipped with six clean rooms.
• Messenger RNA (mRNA) development and production: equipped with two IVT production lines, two purification production lines and two LNP production lines.
  
  

Relying on the existing cGMP production bases in the United States, Japan and Europe, AGC Biologics' rich history will lay a solid foundation for the production and operation of the Yokohama base, including:

• More than 30 years of GMP experience.
• Successfully passed 100 regulatory inspections.
• Promote the listing of more than 30 commercial products and obtain the approval of more than 100 independent regulatory agencies.
• Develop and produce more than 400 products for more than 250 customers.