STGen Bio, a subsidiary of Dong-A Socio Holdings, has announced that its Songdo Bio Plant has received current Good Manufacturing Practice (cGMP) approval from the U.S. Food and Drug Administration (FDA). This approval encompasses the plant's facilities for manufacturing Drug Substances (DS) and Pre-Filled Syringes (PFS).
The FDA's decision, which followed an inspection in June, certifies that the Songdo Bio Plant meets stringent U.S. manufacturing standards. This milestone closely follows the plant's attainment of EU-GMP certification from the European Medicines Agency (EMA) last month, marking a significant step in STGen Bio's global expansion.
Implications for Biopharmaceutical Production
With both FDA and EMA approvals secured, STGen Bio is now positioned to produce commercial quantities of its Stelara biosimilar, DMB-3115 (ustekinumab), for distribution in the United States and Europe. Stelara is a medication used in the treatment of autoimmune diseases.
"With these EMA and FDA cGMP approvals, we have secured a global track record and laid the foundation for a global production base that can stably supply high-quality biopharmaceuticals to the three largest markets for biopharmaceuticals -- the United States, Europe and Japan," said Choi Kyung-eun, president of STGen Bio.
Strategic Advantages and Future Prospects
STGen Bio's ability to meet the rigorous demands of global regulatory bodies underscores its commitment to quality and its potential as a contract manufacturing organization (CMO). The company anticipates a surge in inquiries from global pharmaceutical companies seeking reliable manufacturing partners.
"We expect to receive more inquiries from global multinational pharmaceutical giants as we have proved our differentiated competitiveness in producing commercial products as a quality management-based contract manufacturing organization (CMO) company," added Choi Kyung-eun.
