Toward biomanufacturing of pluripotent stem cell derived products: scale out and scale up

Pluripotent stem cell-related products represent a new product category from the pharmaceutical and biotechnology industry. The increased demand in disease research, drug screening and toxicity testing motivates the activities for large-scale production of stem cells or their derivatives through scale out and scale up approaches. This article highlights recent advances and the challenges in scale out and scale up of pluripotent stem cell derived products. While most current processes use scale out approaches, emerging technologies are being explored to fulfill the potential of scale up culture systems with the emphasis on the design of bioinspired process for large-scale biomanufacturing of stem cells.