Cell manufacturability

The manufacturers of cell therapy and regenerative medicine products must design manufacturing operations to deliver the required level of stability. Process consistency, maintenance of the aseptic environment (to prevent contamination), assurance of line separation (to prevent cross-contamination and operational confusion), containment (for avoidance of cross-contamination), and their routine management must be taken into account. In this article, we propose the concept of ‘cell manufacturability’ for process development in order to assist the design of cell manufacturing processes.

Please enter your email to access content Read now