Celltrion renews EU-GMP certification for Songdo production facilities

Celltrion has successfully renewed its European Medicines Agency (EMA) Good Manufacturing Practice (EU-GMP) certification for its 250,000-liter drug substance (DS) and drug product (DP) production facilities at the Songdo campus. This certification ensures the company can maintain a stable supply of high-quality biologics to the European and global markets.

Leveraging this certification, Celltrion aims to increase its total production volume at the Songdo campus by approximately 15% this year. A key driver of this growth is the third plant, which began commercial production in late 2024 and is expected to produce 128 batches this year, a 142% increase from the previous year. The company is also preparing a new DP plant to expand finished product capacity and reduce reliance on external contract manufacturing organizations (CMOs).

To improve profitability and cost competitiveness, Celltrion is implementing high-titer processes to increase antibody protein yields within existing facilities. Additionally, the company’s 66,000-liter facility in Branchburg, New Jersey, serves as a critical node in its global supply chain, currently producing for Eli Lilly while undergoing technology transfer for Celltrion’s own products.

In the same region, Samsung Biologics is also expanding its presence. The company recently announced a 3 trillion won investment to expand its Songdo facilities, aiming to increase its global antibody drug production capacity to 1.385 million liters through the sequential development of plants 6 through 8.