An Industry-Driven Roadmap for Manufacturing in Regenerative Medicine

Abstract

Regenerative medicine is poised to become a significant industry within the medical field. As such, the development of strategies and technologies for standardized and automated regenerative medicine clinical manufacturing has become a priority. An industry-driven roadmap toward industrial scale clinical manufacturing was developed over a 3-year period by a consortium of companies with significant investment in the field of regenerative medicine. Additionally, this same group identified critical roadblocks that stand in the way of advanced, large-scale regenerative medicine clinical manufacturing. This perspective article details efforts to reach a consensus among industry stakeholders on the shortest pathway for providing access to regenerative medicine therapies for those in need, both within the United States and around the world. Stem Cells Translational Medicine 2018;7:564-568.