Lotte Biologics has completed construction of its first plant at the Incheon Bio Campus and received operational approval. The approval comes approximately two years after construction began in 2024. The company aims to respond proactively to the diverse development and commercialization needs of global clients by establishing an integrated production system that combines speed, quality, and production flexibility, positioning itself as a leading global contract development and manufacturing organization (CDMO).
On June 22, Lotte Biologics announced that it has completed the major construction of its first plant at the Incheon Bio Campus and obtained the necessary operational approval.
The approval signifies the completion of the physical infrastructure for production facilities, including site preparation, construction, production equipment, piping, and electrical control systems. Biopharmaceutical production facilities must meet complex cell culture processes and comply with global cGMP (current Good Manufacturing Practice) standards, necessitating high levels of design, construction capability, and systematic quality management.
A representative from Lotte Biologics stated, "We actively incorporated our operational experience and manufacturing know-how from the Syracuse Bio Campus during the construction of the Incheon plant. An automated manufacturing control system (MCS) was established from the design phase to enhance production efficiency and quality competitiveness, maximizing our ability to respond to customer needs during commercial production."
The first plant is designed to produce 120,000 liters of antibody drugs, featuring eight stainless steel bioreactors with a capacity of 15,000 liters each to meet large-scale commercial production demands. It employs the latest bioprocess technologies, including high titer cell culture and perfusion, and has introduced an automated logistics warehouse and real-time monitoring-based operational systems to enhance production stability and operational efficiency.
Notably, the dual-site strategy linked with the Syracuse Bio Campus enables Lotte Biologics to provide a seamless CDMO service from initial clinical production to large-scale commercial production.
The Syracuse Bio Campus will support initial projects and clinical volumes for global clients, while the Incheon first plant will handle large-scale commercial production, establishing a bifurcated system capable of addressing a wide range of project sizes.
James Park, CEO of Lotte Biologics, remarked, "The completion of major construction and the acquisition of operational approval for the Incheon first plant in about two years since groundbreaking is a result of our employees' capabilities, project execution skills, and the strategic support and collaboration from the Lotte Group. We aim to establish ourselves as a trusted CDMO partner based on a global production platform connecting Syracuse and Incheon."
* This article has been translated by AI.
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