Stem Cell Culture Processes

The advances in stem cell science in the past few years have laid the foundation for its transformation to medical technology for regenerative medicine. The prospect of deriving induced pluripotent stem cells from adult somatic cells has indeed brought personalised medicine closer to reality. To harness the potential of these advances, an enabling technology for reliably, consistently, and cost-effectively producing large quantities of high quality cells is critical. The typical manufacturing process of stem cells for clinical applications entails cell isolation, banking, expansion, differentiation, and product cell isolation, followed by formulation, and storage. Manufacturing processes fall into two types; small, multiple parallel and possibly highly automated small reactors for autologous applications, as well as multiple serial reactors for cell expansion resembling the contemporary cell culture process for allogeneic applications but more modest in scale. The requirement of surface adhesion for stem cells makes microcarriers and cell aggregation attractive for process consideration, since three-dimensional culturing provides a growth environment that more closely mimics the natural stem cell niches. The know-how acquired in the last quarter century from the development of bioprocesses for the production of pharmaceutical biologics or of compounds for industrial biotechnology will greatly facilitate the translation of laboratory stem cell culture practice to industrial-scale manufacturing technology.