Industrial translation requirements for manufacture of stem cell-derived and tissue-engineered products

The emerging regenerative medicine field has significant potential to change health care delivery in the 21st century. Primarily, stem cell culture methods and tissue engineering approaches typically adopted in biology labs are not scalable, yet scalability is key to ensuring commercial manufacturing success and delivery to clinic. An early example of how industrial translation made critical improvements to scalable production and provided near-unlimited access to a medicine is the development of penicillin. This chapter considers the challenges for manufacturing and potential solutions to deliver new tissue-engineered products to the clinic. Manufacturing scale is the appropriate scale to generate the desired amount of clinical-grade product in a cost effective way. Bioreactors have been subject to extensive investigation for bone tissue engineering. Perfusion bioreactor systems consistently yield improved osteogenic induction and maturation in mesenchymal cells. Critical quality attributes (CQAs) are not always an appropriate way of defining products due to inherent heterogeneity, particularly across multiple autologous samples.