Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products

Special Report by David Williams (EPSRC Center for Innovative Manufacturing in Regenerative Medicine, UK) where he and his team share their experiences in qualifying the Cell Therapy Manufacturing Facility, focusing on their approach to streamlining the qualification effort, the challenges, project delays and inefficiencies they encountered, and finally the subsequent lessons learned. Institutions working within the field of regenerative medicine are significant contributors to the development of autologous cell-based therapies. However, due to a lack of regulation, funding and quality assurance, qualification for manufacture of autologous cell-based products can prove to be challenging. This Special Report by Paul Hourd, Amit...