PRESTIGE BIOLOGICS CO LTD

Prestige Biologics Co Ltd is a South Korean biopharmaceutical company specializing in Contract Development, Engineering, and Manufacturing Organization (CDEMO) services. Established in June 2015, the company provides end-to-end solutions for the development and manufacturing of antibody drugs, recombinant proteins, and vaccines. It serves a global clientele, offering a range of services from cell line development and process engineering to commercial-scale production and regulatory documentation.

The company operates four manufacturing plants in the Osong biocluster in South Korea, with a total production capacity of 154,000 liters. These facilities are compliant with global Good Manufacturing Practice (GMP) requirements and have received certifications from the European Medicines Agency (EMA) and the Korean Ministry of Food and Drug Safety. Prestige Biologics utilizes its proprietary ALITA Smart BioFactory™, a hybrid manufacturing system that combines single-use technology with customizable engineering to enhance production efficiency and flexibility. This system is designed to accelerate the manufacturing timeline and reduce costs for clients.

Prestige Biologics is part of the Prestige Biopharma Group, which also includes Prestige Biopharma, a company focused on the research and development of biosimilars and novel antibody drugs. This vertical integration allows the group to cover the entire biopharmaceutical value chain, from R&D to manufacturing and commercialization. The company was listed on the KOSDAQ market in March 2021. Key milestones include obtaining EU-GMP certification in 2022 and signing a significant CMO service agreement with Celltrion in 2024. The company has also secured partnerships with major pharmaceutical companies, such as a strategic partnership with Dr. Reddy's Laboratories' subsidiary, Aurigene Pharmaceutical Services Ltd., to serve as a manufacturing hub.

Keywords: biopharmaceutical CDEMO, antibody drug manufacturing, contract development manufacturing, ALITA Smart BioFactory, GMP certified biomanufacturing, vaccine production, recombinant protein, cell line development, process engineering, biopharmaceutical commercialization, single-use bioreactors, regulatory support, Osong biocluster, pharmaceutical manufacturing, clinical trial materials, biosimilar manufacturing, biologics production, aseptic filling, biopharma value chain, antibody therapeutics