Celltrion Completes EU-GMP Renewal for 250,000-Liter Songdo Production Facilities, Expanding Songdo Output by 15%

[Financial News] Celltrion plans to increase this year's output by approximately 15% from last year by raising the utilization rate of its production facilities at the Songdo Campus in Incheon. As production at Songdo Plant 3, which began commercial operations at the end of 2024, becomes fully stabilized, the company plans to meet growing product sales while also improving production costs.
 Celltrion announced on the 22nd that it had completed the renewal of the European Medicines Agency (EMA)'s EU Good Manufacturing Practice (EU-GMP) certification for its drug substance (DS)—the active ingredient responsible for therapeutic effects—and drug product (DP)—the final product administered to patients—production facilities at Songdo Plants 1, 2 and 3, which have a combined capacity of 250,000 liters.
 The EU-GMP renewal is a procedure that reconfirms compliance with European regulatory authorities' quality standards. Based on the renewal, Celltrion plans to ensure a stable supply of its products to global markets, including Europe.
 Plant 3 is leading the production expansion. Celltrion plans to produce a total of 128 batches at Plant 3 this year, approximately 142% more than last year. The company explained that the stabilization of Plant 3's operations and improvements in process efficiency are now translating into a significant increase in output.
 Total output at the Songdo Campus is also expected to rise by approximately 15% this year. Celltrion plans to flexibly adjust production at Plants 1 through 3 to meet growing sales of not only its existing flagship products but also newly approved products.
 Alongside expanding production capacity, Celltrion is accelerating efforts to bring more production in-house. The new DP plant at the Songdo Campus received approval to use the building from the Incheon Free Economic Zone Authority in June. Installation qualification (IQ) and operational qualification (OQ) are currently underway, and commercial production will begin after the relevant regulatory procedures are completed.
 Once the new DP plant becomes operational, it will expand DP production capacity, which is currently concentrated at Songdo Plant 2. The strategy is to broaden in-house production from DS through DP, thereby reducing reliance on external contract manufacturing while improving production scheduling and quality-control efficiency.
 Celltrion is also pursuing process improvements to boost production efficiency. The company is applying high-titer processes to some products, enabling it to produce more antibodies at the same culture scale, and plans to expand their application gradually. The goal is to increase output from existing equipment, reduce the burden of additional facility investments and improve manufacturing costs.
 Celltrion's U.S. production base is also operating. The 66,000-liter production facility in Branchburg, New Jersey, is currently manufacturing contract production volumes for global pharmaceutical companies, while technology transfer is underway for producing Celltrion's own products.
 Celltrion plans to establish a production system that responds to changes in global demand by linking its Songdo and U.S. production facilities. The company intends to diversify regional supply chains by securing a local production base in the United States and prepare for trade and geopolitical variables.
 A Celltrion representative said, "We will expand production at Songdo this year, centered on Plant 3, and strengthen both supply stability and cost competitiveness by utilizing the new DP plant, high-titer processes and our U.S. production base." The representative added, "We will connect our expanded production base to increased product sales and improved profitability, supporting the achievement of record-high results this year."

[email protected] Jung Sang-hee Reporter