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LOTTE Biologics announced that it has completed major construction and obtained approval for use for Plant 1 at its Songdo Bio Campus in Incheon, South Korea.

The milestone was achieved approximately two years after the start of construction in 2024, representing an exceptionally fast project execution timeline among global biologics manufacturing facility construction projects.

The approval for use confirms that the physical construction of the facility has been completed, including site development, building and civil engineering works, production equipment, piping, electrical systems, and control systems. As biologics manufacturing facilities must support complex cell culture processes while meeting global cGMP standards, their construction requires advanced design and engineering capabilities as well as systematic quality management.

LOTTE Biologics incorporated operational experience and manufacturing know-how from its Syracuse Bio Campus into the construction of Songdo Plant 1. From the design stage, the company implemented an automated Manufacturing Control System, or MCS, to enhance production efficiency and quality competitiveness. The facility has also been designed to maximize the company’s ability to provide customized support for customers during future commercial manufacturing.

Songdo Plant 1 is a 120,000-liter antibody manufacturing facility, equipped with eight 15,000-liter stainless-steel bioreactors to support large-scale commercial production demand. The facility also incorporates advanced bioprocessing technologies, including higher-titer cell culture and perfusion processes. In addition, LOTTE Biologics introduced an automated warehouse and real-time monitoring-based operating systems to improve manufacturing stability and operational efficiency.

Through its dual-site strategy linking Songdo Bio Campus with Syracuse Bio Campus in New York, the United States, LOTTE Biologics is now positioned to provide integrated CDMO services that connect early-stage clinical production with large-scale commercial manufacturing. Under this model, the Syracuse Bio Campus will support early-stage customer projects and clinical supply, while Songdo Plant 1 will serve as a large-scale commercial manufacturing base. This dual-site structure enables the company to respond flexibly to a broad range of customer needs, from small-scale projects to large commercial production volumes.

Based on its manufacturing network spanning the United States and Korea, LOTTE Biologics anticipates enhanced support for customers’ regional supply strategies and growing demand for supply chain risk diversification.

LOTTE Biologics plans to begin full-scale commissioning and production system validation in the second half of this year. Through these efforts, the company aims to secure GMP manufacturing readiness early and establish a stable foundation for commercial manufacturing to meet global customer demand. The company also plans to continue strengthening production efficiency and quality competitiveness through data-driven process operations and advanced digital systems.

“Completing major construction and obtaining use approval for Songdo Plant 1 approximately two years after groundbreaking is the result of our employees’ capabilities, dedicated project execution, and strategic support and collaboration across the LOTTE Group,” said James Park, CEO of LOTTE Biologics. “Based on our global manufacturing platform connecting Syracuse and Songdo, we will establish ourselves as a trusted CDMO partner for customers worldwide.”

He added, “With an integrated manufacturing system that combines speed, quality, and production flexibility, we will proactively respond to the diverse development and commercialization needs of global customers and continue growing into a world-class CDMO company.”