GC Biopharma, a South Korean biopharmaceutical company, has partnered with Körber to implement a large-scale Manufacturing Execution System (MES) project across multiple sites. Set to go live within a year, the project marks one of Korea’s fastest MES rollouts.

At the core of the initiative is the implementation of Körber’s PAS-X MES solution at three major manufacturing sites, including facilities producing Hunterase (a treatment for Hunter syndrome) and a range of plasma-derived therapies. The MES will serve as the digital backbone of operations, enabling real-time process visibility, batch traceability, seamless system integration, and enhanced global compliance.

“This MES project is not just about digitalization – it’s a bold step toward redefining manufacturing standards in Korea’s biopharmaceutical sector,” said Woong Shin, VP/Head of Quality Management at GC Biopharma. “Partnering with Körber reflects our shared commitment to innovation and responsibility in delivering high-quality therapies worldwide.”

The project follows a phased rollout plan, with a technical go-live scheduled in 10 months and commercial operations to begin in 14 months. GC Biopharma expects to achieve a 25% reduction in batch cycle time, a 30% improvement in data review efficiency, and full compliance with FDA 21 CFR Part 11 and EU GMP Annex 11.

“Delivering a project of this scale within such a compressed timeline demonstrates the strength of our partnership and shared ambition,” said Andrew Lee, Managing Director Korea, Körber Business Area Pharma. “We’re not just implementing a system – we’re building a foundation for digital excellence.”

This MES project is a cornerstone of GC Biopharma’s digital strategy and a catalyst for operational excellence and accelerated market responsiveness.