Cell Production System Based on Flexible Modular Platform

Abstract The features of manufacturing for cell therapy and regenerative medicine are described by considering stability of operations to take process consistency and maintenance of aseptic environment to prevent the extrinsic contamination, processing independency to prevent cross-contamination and operational confusion, biohazard containment for nonproliferation of contaminants, and their routine managements. In addition, the facility designs using biological safety cabinet and isolator for cell processing are discussed. The advantages of isolator technology lead to the development of the flexible modular platform, realizing the flexible combination of isolator modules such as the manual operation module and incubator module to enhance process versatility accompanied by safety, security, and cost-saving.