Celltrion Finalizing Preparations for Third Plant's Commercial Production

Celltrion announced on the 23rd that its third plant, located in Songdo, Incheon, is undergoing final validation before commencing commercial production. Validation is a critical procedure that objectively verifies and documents whether the product manufacturing process meets predefined standards across all stages, from development to production. This step is mandatory prior to the commercial production of pharmaceuticals.

Since September 2021, Celltrion has invested approximately 270 billion KRW over 27 months to complete the construction of the new five-story plant, which spans approximately 22,300 square meters (about 240,000 square feet). The plant is currently in the performance qualification (PQ) phase, the last stage of validation that ensures the integrity of major equipment and production processes following installation and operational qualification (IOQ).

Once this evaluation is complete, the plant is expected to begin full-scale commercial production in December. With the third plant's annual production capacity of 60,000 liters, Celltrion will achieve a total production capacity of 250,000 liters, combining the 100,000 liters from the first plant and 90,000 liters from the second plant.

The new third plant features specialized facilities for "multi-product small-batch production," with eight 7,500-liter bioreactors. Leveraging these capabilities, the plant can flexibly produce a variety of items, including already commercialized products and those from the subsequent pipeline, reflecting diverse demands.

Moreover, Celltrion has introduced new bioprocessing equipment in the third plant that shortens the cell proliferation phase and expanded the automation technology in the purification process. These advanced technologies aim to maximize production efficiency, potentially leading to production volumes and revenue contributions comparable to or exceeding those of existing facilities.

Ahead of the third plant's commercial production, Celltrion has successfully obtained approvals for several high-efficiency, high-potency products, including Omlyclo(a biosimilar for Xolair), Steqeyma (a biosimilar for Stelara), and Eydenzelt (a biosimilar for Eylea). "As these products enter full-scale commercialization, the role and importance of the third plant, capable of flexible production, will increase significantly," Celltrion forecasted.

The construction of a new drug product (DP) plant on the Songdo campus, aimed for completion in early 2026, is also progressing smoothly. This DP plant, once completed and validated, is scheduled to begin full-scale commercial production in 2027.

A Celltrion representative stated, "The third plant, which has been proactively expanded to meet the demand for subsequent biosimilars currently undergoing new approvals, is in its final inspection stage. With the global demand for biopharmaceuticals increasing annually, we will make company-wide efforts to accelerate our growth."