Celltrion announced on the 23rd that the third plant, completed in Songdo, Incheon, has entered the final validation stage ahead of its commercial production launch within the year. Validation is an essential step required before commercial pharmaceutical production, involving the objective verification and documentation that the product is manufactured according to pre-established standards throughout the entire process from drug manufacturing process development to production.
Celltrion invested approximately 270 billion KRW over 27 months from September 2021 to November 2023 to newly complete the third plant, which has a total floor area of 22,290㎡ and five above-ground floors. After passing installation and operational qualification (IOQ) assessments, the company is currently conducting the performance qualification (PQ), the final validation stage that verifies the completeness of major equipment production processes. Once this evaluation is completed, full-scale commercial production is scheduled to begin in December. With an annual production capacity of 60,000 liters, the third plant’s operation will bring Celltrion’s total production capacity to 250,000 liters by combining it with the existing first plant (100,000 liters) and second plant (90,000 liters).
The new third plant was constructed as a production facility specialized in ‘multi-product small-volume production,’ which economically manufactures various items in small quantities. Equipped with eight 7,500-liter bioreactors, it is designed to flexibly produce a variety of products, reflecting the demand for both already commercialized products and subsequent pipelines. Additionally, the plant maximizes production efficiency by incorporating new culture process equipment that can shorten cell proliferation stages and expanding the application of automation technology in purification processes, integrating the latest technologies. Based on this, the actual production volume and sales contribution of the new third plant are expected to be on par with or exceed those of existing production facilities.
Prior to the commercial production launch of the third plant, Celltrion has recently succeeded in obtaining approvals for high-efficiency, high-titer products such as Omriclo (Zolair biosimilar), Stekima (Stelara biosimilar), and Idenzel (Eylea biosimilar). As these products enter full-scale commercialization, the role and importance of the flexible production capabilities of the third plant are expected to grow even further. Celltrion currently holds approvals for a total of nine biopharmaceuticals and plans to introduce 11 products by 2025 and 22 products by 2030.
Meanwhile, construction of a new drug product (DP) plant within the Songdo campus, targeted for completion in early 2026, is progressing smoothly. Once completed, the DP plant will undergo validation and is expected to enter full-scale commercial production from 2027. Celltrion anticipates that with the DP plant operational, it will be able to respond more swiftly to increasing product demand and reduce costs through internalization of production capacity.
A Celltrion representative stated, “The third plant, proactively expanded to meet the demand for upcoming biosimilars currently undergoing approval, has entered its final inspection stage. As global demand for biopharmaceuticals continues to grow annually, we will make company-wide efforts to accelerate growth through strategic growth plans and proactive market responses.”
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