Celltrion clears European quality hurdle with Songdo plant certification
Summary
Celltrion said Tuesday that it renewed European Good Manufacturing Practice certification for its Songdo campus production facilities in Incheon. The certification covers Plants 1, 2 and 3 and a combined 250,000 liters of drug substance and drug product capacity. The company said it plans to raise total campus production volume by about 15 percent this year, helped by output from Plant 3, which began commercial production in late 2024. It is also preparing a new drug product plant for commercial production after receiving building-use approval in June.
Key Facts
- The EU-GMP certification was issued by the European Medicines Agency and confirms that a facility meets European Union quality standards required to supply pharmaceutical products to the European market.
- The renewal applies to Celltrion's Plants 1, 2 and 3 at its Songdo campus in Incheon, west of Seoul.
- Plant 3 is expected to produce 128 batches this year, up about 142 percent from a year earlier.
- Celltrion received building-use approval from the Incheon Free Economic Zone Authority in June for a new drug product plant that is now undergoing installation and operational qualification testing.
- The company is expanding use of a high titer process to lower per-batch production costs without additional facility investment.
Celltrion's headquarters in Incheon / Courtesy of Celltrion
Korean biopharmaceutical company Celltrion said Tuesday it has renewed European Good Manufacturing Practice (EU-GMP) certification for its Songdo campus production facilities, covering a combined 250,000 liters of capacity across drug substance and drug product manufacturing.
The certification, issued by the European Medicines Agency, confirms that a facility meets European Union quality standards required to supply pharmaceutical products to the European market.
The renewal applies to Celltrion's Plants 1, 2 and 3 at its Songdo campus in Incheon, west of Seoul. The company said it plans to expand total production volume at the campus by about 15 percent this year compared with last year, driven largely by output from Plant 3, which began commercial production in late 2024.
Celltrion projects Plant 3 will produce 128 batches this year, up about 142 percent from a year earlier, as the newer facility stabilizes operations.
The company is also preparing to bring a new drug product plant online, having received building-use approval from the Incheon Free Economic Zone Authority in June.
The facility is currently undergoing installation and operational qualification testing ahead of commercial production, a step that will let Celltrion handle more of its own drug product manufacturing rather than relying on outside contract manufacturers.
Separately, Celltrion is expanding use of a "high titer" process — a method that yields more antibody protein from the same culture volume — to lower per-batch production costs without requiring additional facility investment.
In the United States, Celltrion's 66,000-liter plant in Branchburg, New Jersey, is currently producing contract volume for Eli Lilly while technology transfer proceeds for the company's own products.
"The EU-GMP renewal reconfirms the quality competitiveness and production foundation needed to supply the global market stably," a Celltrion official said.
This article was published with the assistance of generative AI and edited by The Korea Times.
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