Leading South Korean biopharmaceutical business GC Biopharma has teamed up with world-renowned IT company Körber to deploy a massive Manufacturing Execution System (MES) project across several locations.
The project, which is expected to go online in a year, is one of Korea's quickest MES rollouts and highlights GC Biopharma's commitment to long-term growth and operational excellence towards pharmaceutical production. Implementing Körber's PAS-X MES system at three significant production locations, which include facilities that produce Hunterase (a therapy for Hunter syndrome) and various plasma-derived medicines, is the initiative's main focus. As the digital backbone of operations, the MES will facilitate batch traceability, real-time process visibility, smooth system integration, and improved worldwide 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.”
With a technical go-live in 10 months and commercial operations to start in 14 months, the project is implementing MES at a record rate in Korea's intricate biopharmaceutical industry. It is part of a phased deployment plan. GC Biopharma anticipates achieving complete compliance with FDA 21 CFR Part 11 and EU GMP Annex 11, a 25% reduction in batch cycle time and a 30% improvement in data review efficiency.
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