Biomanufacturing Technologies for Regenerative Medicine

Abstract

Regenerative Medicine has the potential to be a game-changer for patients who have damaged tissues or organs due to untreatable diseases, injuries, and congenital conditions. Lab-based innovations have shown great promise in restoring structure and function, but to deliver treatments to large numbers of patients in a clinical setting, new tools and technologies are needed. Regenerative Medicine is a new area of medical research that seeks to automate and scale-up the production and deployment of these groundbreaking solutions. The technologies discussed in this report are intentionally pre-competitive, meaning that the Federal Government may choose to play a role in additional growth via well-informed initiatives. Governmental support can come in the form of additional research & development (R&D) dollars that are magnified by private co-investment, or can be in the form of non-pecuniary actions such as modifications to the regulatory environment to better support this rapidly changing field. Ideally, a cooperative relationship between government and private industry will result in cross-industry, pre-competitive tools that decrease development cost and time while still respecting individual intellectual property ownership within a competitive environment. This report identifies promising biomanufacturing platforms that will provide a foundation for the automation and standardization of the processes associated with successful scale-up and scale-out. After evaluating a range of potential translational technology options according to their suitability for co-investment and cross-industry appeal, two platform technologies and two enabling tools were selected: Platform Technology #1: 3D Constructs, including Organoids, Scaffolds, and Printed Tissues; Platform Technology #2: Biomanufacturing Processes; Enabling tool #1: Scaled-up bioreactors for cell culture; Enabling tool #2: Improvements in cell harvesting, cell processing, and preservation technologies.