Biomanufacturing Technologies for Engineering Biology

Engineering Biology seeks to apply engineering principles to design, modify, and produce customized biological components and systems. The recent advent of tools such as the CRISPR/Cas9 system for gene editing and gene regulation has sharply accelerated development in this exciting field. However, several challenges need to be addressed in order to transition laboratory-scale results to commercial-scale solutions. This report identifies emerging platform technologies that, if matured, will accelerate the growth in the rapidly changing field of Engineering Biology. The conclusions in the report are intended to guide stakeholders from government, industry and academia as they seek to further develop innovations in this field.The technologies that clearly met the selection criteria include: • The key platform technology—Standardized Verified and Tractable Host Cells or Strains for Biomanufacturing—will provide industries with host cells and strains that are amenable to engineering for scale-up or scale-out. The standardized and verified nature of these hosts will streamline regulatory processes and significantly de-risk aspects of the biomanufacturing process. • Several enabling tools are needed to fully realize the potential offered by the development of tractable host cells or strains. These tools will also enable more rapid Design-Build-Test-Learn (DBTL) cycles, which is critical for the development of new host cells or strains. These tools include: (i) High Throughput Omics; (ii) Low-Cost and Error Free DNA Elements and DNA Assembly; and (iii) Efficient, Host-Neutral Gene Editing.National Science Foundation, Grant No. 1552534https://deepblue.lib.umich.edu/bitstream/2027.42/144782/1/EngineeringBiology_Final.pdfDescription of EngineeringBiology_Final.pdf : Repor

Manufacturing 101: An Education and Training Curriculum for Hardware Entrepreneurs

Manufacturing 101 is an education and training curriculum designed to provide Cleantech1 entrepreneurs with the requisite manufacturing knowledge to effectively transition their functional prototypes into commercial products manufactured at scale. Participants in a June 2016 workshop laid the foundation for the development of a new education and training program built around four phases: Engage, Educate, Enhance, and Execute. The curriculum consists of eight modules that describe the topics in manufacturing most relevant to entrepreneurs during product scale-up. The modules described in this report are envisioned to be technology agnostic and applicable to a great majority of early-stage companies building physical products. The recommended curriculum is broad enough to apply to a range of different technologies, but is also sufficiently specific so that entrepreneurs can apply the lessons to their own Cleantech innovations. Upon successful completion of the Manufacturing 101 program, entrepreneurs will gain a basic level of understanding about manufacturing processes, and each student will also understand the current Manufacturing Readiness Level (MRL) of their product. Topics taught in Manufacturing 101 will help entrepreneurs more effectively achieve critical product development and commercialization milestones, and will also give entrepreneurs the knowledge and vocabulary to engage with design engineers, consultants, and manufacturing companies during the product scale-up process.National Science Foundation, Grant No. 1552534https://deepblue.lib.umich.edu/bitstream/2027.42/145151/1/Manufacturing101_Report_FINAL_reduced.pdfDescription of Manufacturing101_Report_FINAL_reduced.pdf : Repor

Democratizing Manufacturing: Bridging the Gap Between Invention and Manufacturing

Entrepreneurs and small firms in the U.S. face significant challenges as they scale up their innovations to volume production. Despite innovative new technologies such as 3D printers, the transition to cost-competitive, large-scale manufacturing can be difficult for domestic firms. To assist small U.S. companies to more effectively ramp up production, MForesight assembled more than 30 experts in manufacturing at a workshop on “Democratizing Manufacturing.” The goal of the workshop was to evaluate the gaps and barriers in technology and education that prevent the competitive design and production of engineered components by small businesses in the U.S. This effort is both timely and important because a large fraction of high-value products are now manufactured outside of the U.S. Companies in Europe and Asia are winning bids to manufacture products designed in the U.S. for a host of reasons, including a willingness on the part of their own governments to consistently invest in manufacturing (both infrastructure and human capital). To successfully compete in the global manufacturing marketplace, the U.S. needs to adopt new strategies for education, technology development, and industrial policy.National Science Foundation, Grant No. 1552534https://deepblue.lib.umich.edu/bitstream/2027.42/145152/1/Democratizing-Manufacturing-Dec2016.pd

Biomanufacturing Technologies for Regenerative Medicine

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.National Science Foundation, Grant No. 1552534https://deepblue.lib.umich.edu/bitstream/2027.42/144783/1/RegenMedicine_Final.pdfDescription of RegenMedicine_Final.pdf : Repor