Features of cell processing based on cell manufacturability and product quality fluctuation

Abstract

The manufacturing of regenerative medicine product consists of variety of processes in upstream, downstream, and outer-stream. Features inherent in cell processing cause the fluctuation of process and the instability of final product quality, requiring a novel doctrine. This article describes the features of cell processing as well as product quality and the importance of the design of cell manufacturability. In addition, the stability of the cells as final product is analyzed in the process of cell dispensing and freezing, determining the lot size of the product with simple indices for cell survival. This evidence confirms the importance of design and systematization of cell processing based on the cell manufacturability.