Celltrion’s 3rd plant in Songdo undergoes final inspection

South Korean biosimilar developer Celltrion Inc. announced on Tuesday that its third plant in Songdo, Incheon, is undergoing final stages of validation ahead of commercial production later this year.

Validation is a process that objectively verifies and documents whether a product is being manufactured according to pre-established criteria throughout the entire manufacturing process, from development to production, before the commercial production of pharmaceuticals.

The Songdo 3rd plant is currently undergoing performance qualification (PQ) evaluations, which verify the integrity of key equipment production processes through installation and operational qualification (IOQ) evaluations, the company said.

Once this assessment is complete, the plant is expected to commence full-scale commercial production in December 2024, according to the company.

Constructed with an investment of approximately 270 billion won ($194.78 million) over 27 months from September 2021 to November last year, the Songdo 3rd plant has a total floor area of about 22,300 square meters and an annual production capacity of 60,000 liters.

It is specialized for multi-product small-scale production, equipped with eight 7,500-liter incubators.

Once the third plant is operational, Celltrion’s total production capacity will reach 250,000 liters when combining the 100,000-liter capacity of the 1st plant and the 90,000-liter capacity of the 2nd plant.

Celltrion recently obtained approval for new biosimilar products such as Omlyclo, Steqeyma, and Eydenzelt at home and abroad, which is expected to boost the role and importance of the 3rd plant once the production and sales of these products are in full swing.

Celltrion is also constructing a new finished drug production plant on its Songdo campus, aiming for completion in 2026. This plant is expected to enter commercial production in 2027.

“As the global demand for biopharmaceuticals increases every year, we will make company-wide efforts to accelerate our growth through strategic growth plans and proactive market responses,” said a company official.