AGC Biologics has expanded its existing long-term manufacturing agreement with a global pharmaceutical company, adding a second supply node at the contract development and manufacturing organization's Copenhagen facility.

The expansion builds on an existing agreement anchored at AGC Biologics' Yokohama site and grows the deal's total value beyond USD 0.56 billion.

Copenhagen Site Gains Six Additional Commercial Biologics Programs

The expanded agreement calls for multi-product drug substance manufacturing across six biologics programs at the Copenhagen site, encompassing process transfer, scale-up, validation, and commercial production.

The move allocates an additional six commercial programs to Copenhagen to consolidate high-volume, single-use biologics manufacturing with one global partner, following the customer's commitment of five commercial biologics programs to the new Yokohama facility.

Interoperability and Dual Submissions as Supply Strategy

According to the announcement, the deal reflects a shared belief that site interoperability and dual submissions are key to unlocking the benefits of local manufacturing for a global supply. Products will launch and move across facilities with several dual regulatory submissions to optimize capacity, cost, and local manufacturing benefits.

Running multiple sites as one integrated supply node lets both companies move production quickly between locations as needs change, capturing levels of flexibility and supply chain robustness that could not be achieved with a single-site supply arrangement.

"This customer is building a more resilient, more flexible supply chain, and they've chosen to do that with us across two continents. This is exactly what we're well-positioned to offer to a market craving geographic flexibility and regionalization while retaining global supply," said Alberto Santagostino, President and CEO of AGC Biologics.

"We've built our single-use strategy around quality, capacity, and deep technical expertise so that when a partner is ready to localize and scale, we can meet them where they are. This deal takes inter-site flexibility to a larger scale, but it builds on our existing experience: two of our customers have already decided to co-launch their products from both our Seattle and Copenhagen facilities," he added.

Leadership Points to Trust Built Across the Network

The agreement further cements AGC Biologics as a prominent global player in single-use bioreactor manufacturing, serving the large-scale mammalian single-use manufacturing needs of major pharmaceutical companies across regions.

According to BDO's bioTRAK database, AGC Biologics maintains one of the largest global networks of single-use manufacturing capacity by volume in the industry. The company supports customers pursuing cross-site launches, geographic flexibility, and regionalized manufacturing strategies across its global network.

"For a customer to bring six additional programs to Copenhagen, after bringing five to Yokohama, tells you everything about the trust our team has earned across the network," said Tadashi Murano, President of AGC Life Science Company.

"Our focus stays on building lasting and trust-based relationships with our pharmaceutical customers, like we have been doing for decades in AGC with our industrial partners across a wide range of industries, including electronics and automotive," he added.

Copenhagen Site Capabilities and Track Record

The Copenhagen expansion announced in 2024 included 18,000 square meters distributed across manufacturing, quality control laboratories, and technical and warehouse areas. That build-out comprises eight 2,000-liter single-use bioreactor production lines, one 500-liter perfusion bioreactor, and two downstream purification lines.

Scientific teams at the Copenhagen site have 25 years of expertise in drug substance development and GMP manufacturing, and customers using the site have received a total of over 50 commercial approvals from more than 20 regulatory agencies.

Customer Identity Withheld

Consistent with standard practice in the biopharmaceutical industry, the customer is not named in the announcement.

AGC Biologics stated that customer names are not disclosed without the customer's consent and that the company regularly enters into confidential manufacturing agreements to protect customers' competitive and regulatory strategies.

On the possibility of further expansion, AGC Biologics noted that it operates GMP manufacturing sites across the U.S., Europe, and Asia, providing capacity for customers to expand into additional regions as their commercial manufacturing needs evolve.

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