From Paper To Performance: A Journey Toward Smart Manufacturing And Quality Excellence

By Jason Yu, Director of Manufacturing Execution Systems (MES), Samsung Biologics; and Kyungjin Moon, Director of Computerized System Validation (CSV), Samsung Biologics

Digitalization is transforming manufacturing worldwide, spanning industries such as electronics, automotive, and advanced materials. In these sectors, integrated data platforms, end-to-end automation, and predictive technologies are already commonplace. The biopharmaceutical industry, however, has advanced at a slower pace. Its highly regulated environment, combined with the critical importance of product quality and safety, has led to continued reliance on manual workflows, paper-based documentation, and isolated digital systems — especially in upstream and downstream production.

Seeing an opportunity to lead change, Samsung Biologics initiated its Manufacturing Execution System (MES) program in 2019. This was conceived not as a routine IT upgrade, but as a long-term strategy to expand production capacity while establishing a smarter, more resilient, and fully compliant manufacturing foundation.

Since then, the MES initiative has grown into a central digital infrastructure supporting real-time process oversight, reliable data management, and improved operational consistency. A key milestone was reached with the launch of Plant 5 in April 2025, the first Samsung Biologics facility to fully adopt MES 1.0. This rollout incorporated new levels of automation, system integration, and validation rigor, setting a higher standard for digital-enabled biomanufacturing.

Building on this success, the company is moving toward a truly “smart factory” model. This vision extends beyond digitized records to include synchronized process automation, automated material handling, MES-driven scheduling, and advanced equipment control. The result is a connected, data-driven production environment designed to strengthen agility, reinforce compliance, and accelerate the delivery of vital medicines to patients with greater reliability and scale.