Expansion processes for cell-based therapies.

Living cells are emerging as therapeutic entities for the treatment of patients affected with severe and chronic diseases where no conventional drug can provide a definitive cure. At the same time, the promise of cell-based therapies comes with several biological, regulatory, economic, logistical, safety and engineering challenges that need to be addressed before translating into clinical practice. Among the complex operations required for their manufacturing, cell expansion occupies a significant part of the entire process and largely determines the number, the phenotype and several other critical quality attributes of the final cell therapy products (CTPs). This review aims at characterizing the main culture systems and expansion processes used for CTP production, highlighting the need to implement scalable, cost-efficient technologies together with process optimization strategies to bridge the gap between basic scientific research and commercially available therapies.