Celltrion renews EU-GMP certification for 250,000-liter Songdo facility, targets 15% output boost

Celltrion has successfully renewed European Good Manufacturing Practice (EU-GMP) certification for its drug substance and drug product manufacturing facilities at the Songdo Bio Campus in Incheon, covering a combined capacity of 250,000 liters.

Building on the renewed certification, the company plans to raise annual output at Songdo by about 15 percent from last year to meet growing global prescription demand and accelerate profitability through lower manufacturing costs.

Celltrion announced Tuesday that the European Medicines Agency had completed the EU-GMP renewal for drug substance facilities totaling 250,000 liters across Plants 1, 2 and 3 at Songdo, as well as for its drug product facilities there. The renewal reaffirms the company's manufacturing and quality management capabilities to supply high-quality biopharmaceuticals without interruption to Europe — the world's largest biosimilar market — and to markets worldwide.

Using the certification renewal as a springboard, Celltrion intends to maximize operational efficiency at the Songdo campus and expand total annual output by about 15 percent this year compared with last year. The move is designed both to meet steady demand growth for its core biosimilar products and to ensure stable early supply of new pipeline products that have received regulatory approval in major markets globally.

The primary driver of the campus-wide output expansion is Plant 3, which entered commercial production at the end of 2024. The facility has stabilized operations quickly since launch and is now running at full production capacity.

Celltrion has set a target of 128 batches at Plant 3 this year — a roughly 142 percent jump from the previous year — reflecting how improvements in facility stabilization and on-site process efficiency are translating into meaningful productivity gains. The company will apply flexible production scheduling across Plants 1 through 3 at Songdo, allocating operating lines dynamically based on demand trends for each product.

Progress is also being made on restructuring the cost base through in-house drug product manufacturing. The new drug product factory on the Songdo campus is advancing smoothly through technical validation and regulatory procedures ahead of full commercial launch. Since receiving a building-use approval from the Incheon Free Economic Zone Authority in June, the facility has been completing installation qualification and operational qualification checks on schedule.

Once regulatory procedures are finalized and the new drug product factory begins commercial operations, drug product capacity — previously concentrated at Plant 2 — will expand significantly. Celltrion plans to handle the entire production process in-house, from drug substance cultivation through drug product formulation and packaging, sharply reducing its reliance on external contract manufacturing. Beyond cutting outsourcing costs, the move is expected to secure scheduling independence, raise product quality control standards, and contribute substantially to improving the cost of goods sold over the medium to long term.

Alongside physical capacity expansion, Celltrion is pursuing process technology innovation to increase production yield per unit volume. The company has already applied high-titer production processes — which dramatically boost protein expression levels within the same culture volume — to select products in commercial production. It plans to extend high-titer technology to additional product lines in stages, increasing output per batch and lowering manufacturing costs.

As high-titer process adoption widens, Celltrion expects to maximize output from existing facilities without the large capital expenditure that additional physical expansion would require. With higher facility utilization and improved yields working in tandem, fixed costs per unit will fall, creating a virtuous cycle in which rising production volumes translate directly into improved profitability.

Work to link overseas production hubs as a hedge against global supply chain uncertainty is also on track. The 66,000-liter facility in Branchburg, New Jersey, is ramping up as a key forward base for the North American supply chain. The site is currently producing contract manufacturing volumes for Eli Lilly while simultaneously carrying out technology transfers for Celltrion's own products.

Once Lilly's contract manufacturing volumes and Celltrion's own product output are both running locally, the company will have a powerful buffer against US trade and geopolitical risks, as well as a diversified supply chain built on direct US production. Celltrion plans to consolidate a global production network — anchored by its Songdo base in Korea and its US facility — capable of responding swiftly to sudden shifts in global pharmaceutical demand.

Celltrion's strategy is to reinforce supply continuity in Europe while driving down costs through in-house drug product manufacturing and high-titer yield improvements, maximizing profitability as markets expand. "The EU-GMP renewal for the Songdo campus production facilities again confirms our quality competitiveness and production foundation for stable global supply," a company official said. "This year, we will expand Songdo output centered on Plant 3 while leveraging the new drug product factory, high-titer processes and our US production hub to strengthen both supply stability and cost competitiveness."