A bird’s-eye view of Celltrion’s Songdo campus in Incheon, South Korea
South Korea’s largest biosimilar maker Celltrion Inc. said on Tuesday that its third plant in Sondgo, west of Seoul, is undergoing process valuation testing, or the final stage of inspection, before starting commercial production in December this year.
Process validation refers to the procedures of gathering objective evidence through the design and manufacturing of medical products to ensure they are consistently manufactured to meet the pre-determined standards.
Celltrion said it has also passed the qualification tests for installation and operations of production equipment at the new factory on its Songdo campus.
It is now going through the performance qualification test for the manufacturing equipment. Once it passes the qualification test, it will kick off commercial production in December.
Celltrion has poured about 270 billion won ($195 million) into building the third plant on its Songdo campus between 2021 and 2023. The new five-story facility measures 22,300 square meters of floor area with a capacity of producing 60,000 liters annually.
It is designed for small-scale production of a range of pharmaceutical products to flexibly respond to market demand. Eight cell culture incubators for 7,500 liters were installed in the plant.
The new factory will raise the drugmaker’s biologics production from cell culture incubators to 250,000 liters a year, including 100,000 liters of the first plant and 90,000 liters of the second one on the Songdo campus.
Celltrion is ramping up production capacity as it is diversifying its portfolio. It has secured domestic approval for new biosimilars, including Omlyclo, a biosimilar of allergic asthma treatment Xolair; Steqeyma, a generic version of antibody medication Stelara; and Eydenzelt that has the same substance as that for Eylea, a treatment for wet age-related macular degeneration.
Celltrion is also building a new finished pharmaceuticals manufacturing plant within the Songdo campus, with an aim of completion in 2026. The new plant is scheduled for commercial production in 2027.
By Jeong Min Nam
peux@hankyung.com
Yeonhee Kim edited this article
