[BioUSA] STGen Bio to Quadruple CMO Production Capacity Within 5 Years

After Achieving First Operating Profit Last Year, Aiming for 80 Billion KRW in Sales This Year
Possesses cGMP-Certified Manufacturing Facility at a Single Site

STGen Bio, a contract manufacturing organization (CMO) specializing in biopharmaceuticals under the Dong-A Socio Group, will quadruple its production capacity through the construction of a second plant.

Choi Kyungeun, CEO of STGen Bio, is explaining future plans to reporters at the 2025 Bio International Convention (BioUSA) held in Boston, USA, on the 17th (local time). Photo by Choi Taewon

Choi Kyungeun, CEO of STGen Bio, met with reporters at the 2025 Bio International Convention (BioUSA) held in Boston, USA, on the 17th (local time), and said, "We plan to expand our production capacity, which is currently 9,000 liters based on animal cell culture bioreactors for active pharmaceutical ingredients, to 35,000 liters within three to five years by completing our second plant. This will ensure the sustainability of our business."

After achieving an operating profit for the first time last year, the company has set even higher goals for this year. CEO Choi stated, "Last year, our sales reached 58.9 billion KRW, up 14.4% from the previous year, and our operating profit was 1.7 billion KRW. This year, we plan to drive the business more aggressively and deliver results that surpass last year's performance." The company has already recorded about 20 billion KRW in sales in the first quarter alone and expects to exceed 80 billion KRW by the end of the year.

According to CEO Choi, the foundation for these achievements lies in the company's end-to-end process capabilities. STGen Bio is the only CMO in Korea that has a cGMP (current Good Manufacturing Practice) certified manufacturing facility at a single site. This enables one-stop production from active pharmaceutical ingredients to pre-filled syringe (PFS) filling.

CEO Choi explained, "Since 2019, we have been carrying out full processes from DS (drug substance) purification to PFS finished products and secondary packaging, and we have products that have been exported to Japan for over five years. This, combined with obtaining global approvals, has proven our quality standards."

Currently, STGen Bio has DS production facilities with a capacity of about 9,000 liters and finished drug product (DP) production facilities in the form of PFS. The company exclusively manufactures Dong-A ST's biosimilar 'Imuldosa' (a Stelara biosimilar) and supplies it to global markets including Japan, Europe, and the United States.

In addition, STGen Bio passed inspections by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) at the same time, and has received GMP (Good Manufacturing Practice) certification from regulatory authorities in eight countries including the United Kingdom, Thailand, and Turkiye. This year, the company also plans to obtain GMP certification from Brazil's National Health Surveillance Agency (ANVISA).

This content was produced with the assistance of AI translation services.