[Edaily Reporter Shin Ha-yeon ] #ENCell Co., Ltd., a company specializing in contract development and manufacturing (CDMO) of cell and gene therapies, has been selected for a government-funded project by the Ministry of Trade, Industry and Energy and will embark on the development of automation technology for advanced biopharmaceutical manufacturing processes.

ENCell Co., Ltd. announced on the 23rd that it had been selected for the “Development and Validation of a Closed-Loop Automated Manufacturing System for Cell and Gene Therapies” project, part of the “2026 First Round of R&D Projects in the Biohealth Sector” organized by the Ministry of Trade, Industry and Energy.

The goal of this project is to enhance production efficiency and ensure consistent quality by implementing closed-loop systems, automation, and standardization—key elements of cell and gene therapy manufacturing processes—and to develop and validate a manufacturing system that can be utilized in both clinical and commercialization phases.

The company explained that this project is particularly significant because it aims not merely to develop equipment, but to establish a closed-loop automated manufacturing platform that can be applied to actual GMP (Good Manufacturing Practice) production sites.

Cell and gene therapies involve complex manufacturing processes due to the high proportion of patient-specific or small-batch, high-variety production. Consequently, ensuring sterility, process reproducibility, quality control efficiency, and scalability for commercialization are considered key factors in industrial competitiveness.

ENCell Co., Ltd. will carry out the project as part of a consortium comprising the lead institution, ATI, and the co-research institution, iCell. ATI will be responsible for developing the closed-loop automated manufacturing equipment, while iCell will handle the development of cell culture devices.

Based on its experience operating as a CDMO for cell and gene therapies and its GMP manufacturing infrastructure, ENCell Co., Ltd. plans to verify the process suitability, manufacturing reproducibility, integration with quality control, and GMP applicability of the developed system.

The company noted that this project is particularly significant as it represents a demonstration-based collaboration model that combines equipment development, culture technology, and GMP process validation capabilities.

An ENCell Co., Ltd. official stated, “In the cell and gene therapy industry, the closure and automation of manufacturing processes are key elements for ensuring production stability, quality consistency, and commercial competitiveness,” adding, “We will contribute to the advancement of domestic cell and gene therapy manufacturing processes by developing and validating an automated manufacturing system that can be applied to actual GMP manufacturing sites.”

The representative added, “Based on our extensive experience in producing various cell and gene therapies, we will actively incorporate the process validation and quality control perspectives required in manufacturing environments to establish a foundation for manufacturing automation that can be utilized in future clinical and commercialization phases.”