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 – a record pace for MES implementation in Korea’s complex biopharmaceutical sector. 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.
With a focus on execution and accountability, the project addresses several critical objectives:
- System integration at scale: PAS-X MES will interface with a broad landscape of systems including SAP ERP, WMS, QMS, LMS, DMS, PBS, MBS, LIMS, and L2 platforms.
- Complex interconnectivity: Custom integrations will support unique business processes across systems to maximize enterprise value.
- Prime contractor leadership: As the main contractor, Körber is responsible for overall project execution, subcontractor coordination, and quality assurance.
- Standardization and quality control: A key goal is the alignment of processes and quality standards across diverse partner contributions.
- Localized expertise: All partners bring dedicated in-country teams to ensure high-quality delivery and responsive support.
“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 collaboration showcases what can be achieved when expertise, trust, and ambition come together. With our global innovation capabilities and strong local execution, we are setting a new standard for fast, high-quality MES deployments in Asia’s pharmaceutical industry. I am proud of our teams for driving this digital transformation journey together with GC Biopharma,” said Oliver Weber, CEO Software, Körber Business Area Pharma.
The deployment is backed by a robust partner network:
- euBiz Solution leads level 2 system integration using COPA-DATA’s Zenon, OT network design (via Wenet), and validation.
- Shinsegae supplies core infrastructure solutions, including Nutanix-based MES servers.
- INiinno drives MES validation efforts to ensure full regulatory alignment.
This MES project is a cornerstone of GC Biopharma’s digital strategy and a catalyst for operational excellence and accelerated market responsiveness. Together, GC Biopharma and Körber are not only setting a new benchmark for MES adoption in Korea – they are defining the future of smart, agile, and compliant pharmaceutical manufacturing.
