FURI | Fall 2019

Development of Biomanufacturing Unit Operations for Human Cell Therapy (HCL) Good Manufacturing Practices (cGMP)

Regenerative medicine (RM) is an emerging technology being developed by scientists, engineers, and clinical specialists to revolutionize medicine. As humans lose tissues and organs due to injury or disease, it is now possible to regenerate 3D tissue from their own cells. Thus, RM offers personalized therapy, which is expected to improve the overall quality of life. However, government regulations, treatment costs, and operative inefficiencies prevent RM development. For RM to realize its full potential, specialized manufacturing tools, processes, and a skilled workforce are required. Key biomanufacturing bio-unit operations include 3D bioprinting, electrospinning, and custom bioreactors.