Celltrion has begun the final validation process for its third plant in Songdo, Incheon, before commencing commercial production, the South Korean biosimilar giant announced Tuesday.
The validation process is a critical step before the commercial production of drugs, which involves objectively verifying and documenting that products are manufactured to meet predefined standards from drug development to production.
Celltrion invested some 270 billion won ($194 million) for the third plant's completion since 2021, which has a total floor area of about 22,300 square meters and five floors above ground.
The company is currently conducting a performance qualification evaluation to ensure the major equipment production processes meet standards through installation and operational qualification. Commercial production is set to begin in earnest in December after the assessment is fully completed.
With the third plant’s annual production capacity of 60,000 liters, Celltrion's total production capacity will reach 250,000 liters. This includes 100,000 liters from its first plant and another 90,000 liters from its second plant.
The new third plant is designed specifically for economically producing a variety of products in small quantities, maximizing efficiency. It features eight 7,500-liter incubators, allowing for flexible production to meet the demand for subsequent pipelines on top of already commercialized products.
Celltrion has concentrated on maximizing production efficiency by integrating the latest technologies, such as new cultivation process facilities that shorten the cell proliferation stage and expanding automation in the refining process.
Prior to the third plant’s commercialization, Celltrion successfully obtained approval for high-efficiency, high-titer products such as Omlyclo (Xolair biosimilar), Steqeyma (Stelara biosimilar) and Eydenzelt (Eylea biosimilar).
The flexible production capabilities of the third plant are expected to play a crucial role as these items enter full-scale commercialization. Currently, Celltrion holds nine biopharmaceutical licenses and plans to introduce 11 products by 2025 and a total of 22 products by 2030.
"The third plant, expanded preemptively to meet the demand for new biosimilars undergoing approval, has entered the final inspection stage," a Celltrion official said. "As global demand for biopharmaceuticals increases each year, we will strive to accelerate growth through strategic plans and proactive market responses."
Meanwhile, construction of a new finished drug product manufacturing plant is underway, also located within Celltrion's Songdo Campus, with completion aimed for early 2026 and commercial production planned to begin in 2027.
