[Edaily Reporter Kim Seung-kwon ] Artificial intelligence (AI) and digital transformation (DX) are currently revolutionizing the pharmaceutical manufacturing landscape. Pharmaceutical production sites, which once relied on the skill and experience of human workers, are rapidly transforming into “intelligent production systems” capable of data-driven decision-making and automated process optimization. In particular, the adoption of AI on the manufacturing floor is expanding beyond mere improvements in production efficiency to encompass strict quality control and ESG (Environmental, Social, and Governance) management, rapidly emerging as a new core competitive advantage for companies.

The government has also identified manufacturing competitiveness—driven by the convergence of AI and digital innovation—as a key growth engine for the future pharmaceutical and biotech industries and has begun providing full-scale support. The Ministry of SMEs and Startups is helping to expand smart factories through initiatives to build autonomous factories and support the rapid commercialization of AI-based products in the manufacturing sector. Meanwhile, the Ministry of Environment and the Ministry of Health and Welfare are also serving as strong partners to the industry by promoting projects to advance eco-friendly manufacturing innovation and enhance export competitiveness in pharmaceutical manufacturing, respectively.

HANDOK Inc. Builds Intelligent Factory Based on ‘AI Supervisor’… CMO Revenue Also ‘Soars’

HANDOK Inc.(002390)HANDOK Inc. recently emerged as a leader in AI-based smart manufacturing innovation by being selected—as the only pharmaceutical and biotech company—for the Ministry of SMEs and Startups’ “2026 Support Program for the Rapid Commercialization of AI Applications in the Manufacturing Sector.” HANDOK Inc. plans to invest a total of 4.2 billion won over the next two years to build an intelligent factory based on an “AI Orchestration Platform.”

The key lies in utilizing AI not merely as a tool for process improvement, but as “core infrastructure that integrates the entire manufacturing operations system.” By introducing an “AI Supervisor” system—where various specialized AI modules perform specific roles in each process and are managed holistically—the company will unveil a single intelligent manufacturing system that encompasses production, quality, logistics, and facilities. This marks an innovative shift from the existing “human-managed automated factory” to a structure where “AI makes decisions and humans verify them.” Furthermore, the company plans to create a “one-person remote monitoring” environment linked to digital twins and implement a “manager-approved AI operating system” that complies with Good Manufacturing Practice (GMP) standards to ensure safe, regulatory-compliant AI models.

HANDOK Inc.’s “Evolved Manufacturing Innovation Model” is already translating into tangible business results. HANDOK Inc., which provides contract manufacturing (CMO) and quality control (QC) services to global pharmaceutical companies such as Sanofi and Janssen, recorded sales of approximately 40 billion won in its CMO division alone in 2025—a 13% increase from the previous year. In addition, the company is achieving tangible results in eco-friendly manufacturing innovation by introducing solar power generation and energy management systems—which cover approximately 16% of its factory’s energy consumption with renewable energy—and by expanding paperless operations and electronic labeling (E-label).

CHONGKUNDANG Sets Sights on Autonomous Operations with ‘Metaverse Factory’ Combining AI and Digital Twins

CHONGKUNDANG(185750)The company is focusing its efforts on establishing a fully autonomous production system powered by AI. Through the Ministry of SMEs and Startups’ Autonomous Factory Construction Project, it is building a “Metaverse Factory” at its Cheonan plant that combines AI, digital twins, and multimodal generative AI.

The core objective is to monitor production processes in real time by creating digital twins identical to the actual production facilities in a virtual space, while generative AI independently analyzes vast amounts of manufacturing data to simultaneously boost production efficiency and quality. The company’s strategy is to set the standard for next-generation smart factories through an “AI control” system that goes beyond simple centralized monitoring, enabling AI to predict abnormal situations and actively collaborate with workers.

Huons Co., Ltd. has placed a strong emphasis on ensuring the reliability of manufacturing data and advancing its quality management system. Selected this year for the inter-ministerial smart factory construction project jointly promoted by the Ministry of SMEs and Startups and the Ministry of Health and Welfare, Huons Co., Ltd. is implementing a DX-based operational system on the injection and eye drop production lines at its Jecheon Plant No. 2.

While expanding the successful digital operational know-how from Jecheon Plant No. 1—a former smart factory pilot site—to Plant No. 2, the company is also significantly strengthening its data integrity management system based on Computer System Validation (CSV). Through this, Huons plans to secure data traceability capable of fully meeting the increasingly stringent requirements of global GMP inspections and gain a competitive edge in the global market.

SAMSUNG BIOLOGICS Integrates Cutting-Edge Technologies into Global Production Hubs… Leading the Way in ‘Smart Manufacturing’

SAMSUNG BIOLOGICS(207940)In step with the expansion of its overwhelming global production capacity, the company is elevating its AI-based smart manufacturing system to global standard levels. It is proactively applying manufacturing AI at global hubs such as its Rockville, U.S., production facility and is demonstrating unhesitating progress in integrating cutting-edge technologies, including exploring the future introduction of humanoid robots on the production floor.

In particular, at Plant No. 5, which recently began operations, the company has fully implemented digital twin technology to maximize the efficiency of technology transfer (Tech Transfer). It has also established a comprehensive automation infrastructure that links production (MES) and quality (QES) data with AI in real time. Furthermore, by utilizing low-carbon green cement and recycled construction materials during the construction process to drastically reduce carbon emissions, the company is taking the lead in practicing ESG management through the establishment of eco-friendly smart factories.

An industry insider stated, “AI and digital innovation have now moved beyond being mere tools for improving productivity; they have become essential survival strategies that determine the competitive landscape of pharmaceutical manufacturing.” The insider added, “How quickly and precisely a data-driven quality prediction system is established will determine K-Pharma’s future dominance in the global market.”