STgen Bio’s Songdo bio plant passes EU GMP inspection

STgen Bio said Thursday that its biopharmaceutical production facility in Songdo, Incheon, has passed the GMP (Good Manufacturing Practice) due diligence conducted by the European Medicines Agency (EMA).

STgen Bio, which is responsible for manufacturing Stellara’s biosimilar DMB-3115, which was jointly developed by Dong-A ST and Meiji Seika Pharma of Japan and completed the European application in July last year, received the EMA’s due diligence inspection of the manufacturing facility this past July.

As both the DS (Drug Substance) and PFS (Prefilled Syringe) manufacturing facilities at its Songdo biopharmaceutical plant have obtained EU-GMP certification, STgeb Bio plans to begin commercial production of DMB-3115 in the second half of this year.

STgen Bio, a subsidiary of Dong-A Socio Holdings, provides biopharmaceutical contract manufacturing organization (CMO) services and has a 9,000L facility for producing active pharmaceutical ingredients and finished aseptic injectable drugs related to antibodies and recombinant proteins.

In 2019, the company obtained GMP conformity approval for its production facility from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the commercial production of DA-3880, a darbepoetin-alpha biosimilar of Dong-A ST. It is awaiting the approval results of the due diligence inspections conducted by the U.S. Food and Drug Administration (FDA) in June and by the Saudi Food and Drug Administration (SFDA) in July.

“By adding global certifications to our production facilities, we are strengthening our competitiveness with manufacturing facilities that can reliably produce and supply high-quality drugs,” an STgen Bio official said. “We plan to secure a global track record by targeting major global markets, including Korea, step by step, and continue to grow sales through this.”