GC Biopharma has selected Körber’s PAS‑X Manufacturing Execution System for simultaneous deployment at three South Korean plants, including facilities that produce Hunterase and several plasma‑derived therapies.
The project, one of the country’s fastest large‑scale MES implementations, is scheduled to reach technical go‑live in 10 months and full commercial operation in 14 months.
The PAS‑X platform will serve as the digital backbone for GC Biopharma’s production network, providing real‑time process visibility, end‑to‑end batch traceability and native integration with SAP ERP, warehouse, quality, learning and laboratory systems. GC Biopharma projects a 25 % cut in batch cycle time and a 30 % gain in data‑review efficiency, while meeting FDA 21 CFR Part 11 and EU GMP Annex 11 electronic‑records requirements.
Körber is acting as prime contractor, coordinating system configuration, validation and infrastructure with partners euBiz Solution, Shinsegae and INiinno. The integration scope includes level‑2 automation via COPA‑DATA’s Zenon, Nutanix‑based server architecture and comprehensive validation to secure regulatory alignment.
GC Biopharma views the accelerated rollout as a cornerstone of its broader digital‑transformation strategy, aimed at standardising quality controls and boosting responsiveness to market demand across its biologics portfolio.