Curocell earns ISO 45001 certification, reinforcing safety standards in CAR-T manufacturing

Curocell announced Wednesday that it has officially obtained ISO 45001 certification, the international standard for occupational health and safety management systems established by the International Organization for Standardization (ISO).

ISO 45001 is an international standard that requires organizations to systematically identify, evaluate, and improve risk factors to prevent industrial accidents and create safe working environments. It serves as an objective benchmark for verifying a company's occupational health and safety management capabilities.

CAR-T therapy is a patient-specific, cell-based treatment that uses immune cells collected from each patient. Its manufacturing process demands high-level process safety management and workplace environment control, including cell manipulation, aseptic procedures, and the handling of biological materials.

Considering these characteristics, Curocell has pursued initiatives such as establishing a comprehensive risk factor analysis system, enhancing work standard manuals, strengthening protective equipment management, and internalizing accident prevention and response processes. This certification acknowledges that the company’s occupational health and safety management system meets international standards and operates at a level suitable for real-world industrial environments.

Curocell plans to maintain a safe manufacturing environment to ensure process stability and consistent quality as it moves into full-scale commercial manufacturing and production expansion. To achieve this, the company will continue to conduct regular risk assessments, embed safety leadership, enhance specialized employee training, and advance its environmental and equipment monitoring systems at its production facility.

“As CAR-T therapy manufacturing is a process directly linked to patients’ lives, the safety of the manufacturing environment and worker protection system are core to our operations,” Curocell CEO Kim Gun-soo said. “Building on this ISO 45001 certification, we will further strengthen our safety culture across personnel, facilities, and the environment, and continuously improve our manufacturing and operational systems to meet global standards.”