Celltrion announced on the 5th that its third plant located in Songdo, Incheon, has completed performance qualification (PQ) and other procedures to verify the completeness of key equipment production processes, and has commenced full-scale commercial production of drug substances (DS).
From September 2021 to November 2023, Celltrion invested approximately 270 billion KRW over 27 months to complete the construction of the third plant, which has a total floor area of about 22,300 square meters (approximately 6,760 pyeong) and spans five floors. The third plant has a capacity of 60,000 liters, adding to Celltrion’s total biopharmaceutical production capacity of 250,000 liters, including the first plant with a capacity of 100,000 liters and the second plant with 90,000 liters.
The third plant is focused on “small quantity batch production” to quickly respond to market changes and demands by predicting pharmaceutical needs in line with evolving biopharmaceutical trends. To maximize economic efficiency, Celltrion aims to enhance production efficiency to yield more biopharmaceuticals from the same amount of culture fluid, thereby producing high-yield products. The third plant is expected to match or exceed the production volume and revenue contribution of existing production facilities.
Equipped with eight 7,500-liter bioreactors, the third plant incorporates cutting-edge technology by shortening the cell proliferation phase, expanding new cultivation process facilities, and automation technology. Areas vulnerable to contamination are constructed as cleanrooms, high-concentration dilution methods are applied in the purification process, and the size of piping and tanks is optimized. Some equipment has been localized to enhance maintainability and contribute to domestic production.
With the third plant entering full-scale commercial production, Celltrion’s production of new biosimilars and follow-up pipeline products that have recently received approval in major overseas markets is gaining momentum. Celltrion plans to continue commercial production of existing products at the 1st and 2nd plants while advancing production of existing and newly developed products at the 3rd plant, aiming to boost operational rates and create synergy with its existing facilities.
Additionally, Celltrion is constructing a new finished pharmaceutical (DP) plant on the Songdo campus, targeting completion by 2026. The DP plant is expected to enter full-scale commercial production by 2027. Once the DP plant is operational, Celltrion anticipates more swiftly responding to increased product demand and achieving cost reductions through internalizing production capability.
A Celltrion representative stated, “With the full-scale commercial production at the third plant, Celltrion has inaugurated an era of 250,000-liter biopharmaceutical production. We will strive to maximize production flexibility and efficiency through a small batch multi-product production system to supply high-quality biopharmaceuticals to the global market.”