Development of a novel modular system for cell production: reproducibility of an iPS cell-based products in manufacturing using the motion-controlled machinery.

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Background & Aim When the production of cell-based products in the container handling which is handled by opening the vessels, most of cell processing facilities, which install commercial isolators, are difficult to be operated with high availability. The main steps of the cell production, such as medium exchange or passaging operations, must work at defined intervals to grow the cells. Therefore, general assembly line operation is not suitable for cell production. On the other hand, unlike safety cabinets, isolators are not suitable for production methods sharing the chamber as a common housing. It is difficult to achieve both quality and cost-saving using the current cell processing methods, but we wish to provide a practical solution to resolving these issues. If common apparatuses could be shared between multi-manufacturing lines in parallel, we think it would contribute to significant cost-saving. Therefore a novel process assembly method, called a flexible modular platform (fMP), has been developed by combining modules composed the individual aseptic isolator. A key technology of fMP is the aseptic connection interface for transfer between modules which is decontaminated so that they can be joined in a single process. Methods, Results & Conclusion In this study, the difference in reproducibility between manual and automatic manufacturing was investigated. While standard operation procedures of all the processes for a product (retinal pigment epithelium cells) have been prepared, motions of these procedures were optimized for automated manipulation. The process verification has been carried out by parallel production of multiple batches. When the fMP was adopted in these automated production, it was found to be able to reduce the personnel cost to more than 1/10.