Collaborative Findings on Manufacturing Needs for Biofabrication of Engineered Tissues and Organs

Abstract: Since its inception as a field in the late 1990s, tissue engineering and regenerative medicine (TERM) has struggled to deliver on the promises of transformative medical technologies to repair, replace, or regenerate tissues and organs damaged by disease, congenital defect, age, or trauma. Some stagnation in the TERM field is due to the inability to engage in manufacturing of these products on a large scale and/or with reliability. Unlike small-molecule drugs or medical devices, the technology to create and manufacture TERM products is complex and can be highly variable. One example of this is 3D bioprinting, which is described as the use of three-dimensional (3D) printers to create tissue engineering scaffolds or print tissues and organs with or without live cells. To discuss the issues surrounding large-scale biomanufacturing of TERM products using bioprinting technology, the University of Minnesota held a 1-day workshop on “Manufacturing Needs for Biofabrication of Engineered Tissues and Organs” in conjunction with the annual “Design of Medical Devices” conference. Through a series of talks from industry experts and breakout sessions, attendees developed problem statements and next steps for the use of bioprinting in a biomanufacturing process in five areas: unit operations in biomanufacturing, scaling and automation, bioprinting for engineered tissues, the role of standards in bioprinting, and technological gaps in bioprinting. Finally, workshop participants emphasized the need for quality raw materials, consensus standards, and process workflow optimization throughout biomanufacturing, but especially for processes that use bioprinting technology. Recent efforts by TERM-focused public-private partnerships like the BioFabUSA program will help address the challenges identified in the workshop to make bioprinting a bona fide biomanufacturing process and TERM products a viable hope for patients. Lay Summary: A one-day conference brought together experts in industry and academia to discuss what is needed to bring biofabrication from its current prototype stage to reproducible, manufactured tissue and organ products in the future.