Stem cells have the potential to have a dramatic impact in therapeutics of many diseases and injuries, including myocardial infarction, diabetes, Parkinson's and spinal cord injury. Translating stem cell promise into clinical therapies for routine use is limited by current cell culture technology, which can yield small batches of cells appropriate only to treat a limited number of patients. Realizing the potential of stem cells requires the capacity to biomanufacture high quality cells at least 2-4 orders of magnitude greater in number. Thus, meeting the growing need for stem cells in a commercially viable manner will require technologically-advanced production facilities and unique business models.

• Identify the technical and commercial challenges unique to the manufacturing of stem cells
• Highlight current stem cell manufacturing and commercialization strategies
• Discuss the regulatory environment for the manufacturing and translation of stem-cell based clinical therapies