Abstract
Recent developments for the manufacturing of cell-based products have focused on the advancement of products to clinical trials or commercialization, with awareness of the importance of cost-based effectiveness in cell manufacturing. The mechanization of cell-processing operations is advantageous for the reproducibility and stability of product quality and is thought to reduce the cost-of-goods through the life cycle of the product in a scale-up system; however, few cases of the implementation exist. This study developed an estimation method for the resource expenditure of cell-processing operations in the manufacturing of cell-based products. To estimate resource expenditures, we evaluated the manufacturing processes by operations involving entering into the surrounding area of cell processing zone, materials loading, cell-processing operation, cleaning, and leaving from the surrounding area. The cell-processing operation is applicable to manual or robotic cell manufacturing system in a biosafety cabinet or an isolator system. In cases of low annual batch numbers of manufacturing (batch number <33), the resource expenditure of cell-processing operations in a robotic operation system installed in the isolator system is estimated to be higher compared with a manual operation system in the isolator system due to additional initial costs for design and fabrication of the robotic operation system containing robot arms. With increasing numbers of annual batches, the resource expenditure decreases for robotic operating system, leading to an advantageous juncture where the resource expenditure of a robotic operation system is equivalent to that of a manually operated system, whereby the labor cost for cell-processing operations rises. In addition, the expertise of operations required for cell manufacturing is suggested to foster potential risks associated with the operation skills or turnover of operators, and the cost of education and training increases due to the necessity of persistent human resource development. Collectively, revealing the approach for installation of robotic operation system in cell manufacturing.