Celltrion’s 3rd plant to become operational in December

Celltrion said its third plant, located in Songdo, Incheon, has entered the final validation phase before commencing commercial production. 

According to the company, validation is a critical step required before the commercial production of pharmaceuticals as it involves objectively verifying and documenting that the product is manufactured in accordance with predetermined criteria throughout the entire manufacturing process, from development to production.

Celltrion has invested approximately 270 billion won ($195 million) over 27 months, from Sept. 2021 to Nov. 2023, to construct the new five-story plant with a total floor area of about 22,300 square meters. 

Following the installation and operational qualification (IOQ) of major equipment, the company is currently conducting performance qualification (PQ), the final validation phase, to ensure the integrity of the production process. 

Once the evaluation is completed, the company plans to start full-scale commercial production in December.

The third plant, with an annual production capacity of 60,000 liters, will increase Celltrion's total production capacity to 250,000 liters, including the existing 100,000 liters from the first plant and 90,000 liters from the second plant. 

Celltrion stressed that the new facility will specialize in multi-product small-batch production. The plant is equipped with eight 7,500-liter bioreactors, enabling flexible production of various products to meet the demands of both existing and future pipelines.

The company also stressed that it has incorporated the latest technologies to maximize production efficiency in the new plant, which includes new cell culture processes that shorten cell proliferation stages and the expansion of automation technologies in the purification process.

Celltrion said that the completion of the third plant comes at an important time for the company as it recently succeeded in obtaining approvals for high-titer products such as Omlyclo (Xolair biosimilar), Steqeyma (Stelara biosimilar), and Eydenzelt (Eylea biosimilar). 

Meanwhile, the construction of a new drug product (DP) plant on the Songdo campus, slated for completion by early 2026, with the company expecting to begin commercial production in 2027 following validation. 

“The third plant, preemptively expanded to meet the demand for upcoming biosimilars, is now in its final inspection phase,” a company official said. “As the global demand for biopharmaceuticals increases annually, we are committed to accelerating our growth through strategic planning and proactive market responses.”