Company Profile of Prestige Biologics

“CDMO facilities with state-of-the-art technology and equipment” Established in 2015 in Osong, Korea, PBL is a technology-driven Contract Development Manufacturing Organization (CDMO) that has expanded its operations. The facility received GMP certification from the Ministry of Food and Drug Safety (MFDS) in Korea and the European Union (EU) in 2019 and 2022, respectively. US FDA inspections for both campuses are expected early in 2025. Single-use technology is implemented in plants 1, 2, and 3, while a hybrid system combining single-use technology for upstream processes (USP) and stainless steel for downstream processes (DSP) is in Plant 4. These separate campuses (Campus 1 includes plants 1 and 2, and Campus 2 includes plants 3 and 4), with a total scale of 154,000 L, ensure uninterrupted product supply. We've supported the submission of three biosimilars and one first-in-class antibody drug for Investigational New Drug (IND) and/or Clinical Trial Application (CTA) approval. One of them is under review by the European Medicines Agency (EMA) for market authorization.