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Global Assessment of Biological Engineering And INTERNATIONAL ASSESSMENT OF RESEARCH IN BIOLOGICAL ENGINEERING & MANUFACTURING This study was sponsored by the U.S. National Science Foundation (NSF). Panel Stephen W. Drew, Ph.D. (Chair) Gang Bao, Ph.D. Drew Solutions, LLC Wallace H. Coulter Dept. of Biomedical Engineering 126 Mountain Avenue M Building - 4100M Summit, NJ 07901 Georgia Institute of Technology Atlanta, GA 30332-0535 Christopher J. Bettinger, Ph.D. Kam Leong, Ph.D. Materials Science and Biomedical Engineering Department of Biomedical Engineering Carnegie Mellon University Columbia University Wean Hall 4315, 5000 Forbes Avenue Mail Code 8904 Pittsburgh, PA 15213-3890 |1210 Amsterdam Avenue New York, NY 10027 Madhusudan V. Peshwa, Ph.D. Kaiming Ye, Ph.D. Research and Development Department of Biomedical Engineering MaxCyte, Inc. Watson School of Engineering and Applied Science 22 Firstfield Road, Suite 110 Binghamton University, State University of New York Gaithersburg, MD 20878 PO Box 6000 Binghamton, NY 13902-6000 Other Participants in Site Visits Ted Conway, Ph.D. (Europe and Asia) Athanassios Sambanis, Ph.D. (Asia) General & Age Related Disabilities Engineering Biomedical Engineering and Healthcare (ENG/CBET) Program (GARDE) The National Science Foundation The National Science Foundation 4201 Wilson Boulevard 4201 Wilson Boulevard Arlington, VA 22230 Arlington, VA 22230 Dawn Applegate, Ph.D. (Europe) President and Chief Executive Officer RegeneMed, Inc. 9855 Towne Centre Drive Suite 200 San Diego, CA 92121 WTEC Representatives Patricia Foland (Europe and Asia) Hassan Ali (Europe and Asia) Clayton Stewart, Ph.D. (Asia) WTEC Panel Report on INTERNATIONAL ASSESSMENT OF RESEARCH IN BIOLOGICAL ENGINEERING & MANUFACTURING Final Report on Europe and Asia July 2015 Stephen W. Drew (Chair) Gang Bao Christopher J. Bettinger Kam Leong Madhusudan V. Peshwa Kaiming Ye Copyright 2015 by WTEC. This document was sponsored by the National Science Foundation (NSF) and other agencies of the U.S. Government under an NSF cooperative agreement (ENG 0844639) with the World Technology Evaluation Center (WTEC). The U.S. Government retains a nonexclusive and nontransferable license to exercise all exclusive rights provided by copyright. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the United States Government, the authors’ parent institutions, or WTEC. Copyrights to graphics included in this document are reserved by original copyright holders or their assignees and are used here under the Government’s license and by permission. Requests to use any images must be made to the provider identified in the image credits, or to WTEC if no provider is identified. A list of available WTEC reports and information on obtaining them is on the inside back cover of this report. ii WORLD TECHNOLOGY EVALUATION CENTER, INC. (WTEC) R.D. Shelton, President Frank Huband, Senior Vice President and General Counsel Geoffrey M. Holdridge, Executive Vice President Patricia Foland, Vice President for International Operations Hassan Ali, Advance Contractor (Asia) Grant Lewison, Advance Contractor (Europe) Clayton Stewart, Advance Contractor (Asia) Haydon Rochester, Jr., Report Editor ACKNOWLEDGMENTS We at WTEC wish to thank all the panelists for their valuable insights and their dedicated work in conducting this assessment of biomanufacturing, and to thank all the site visit hosts for so generously sharing their time, expertise, and facilities with us. For their sponsorship of this important study, our sincere thanks go to the National Science Foundation. R.D. Shelton President, WTEC WTEC MISSION WTEC provides assessments of international research and development in selected technologies under awards from the National Science Foundation (NSF), the Office of Naval Research (ONR), and the National Institute of Standards and Technology (NIST). Formerly part of Loyola University Maryland, WTEC is now a separate nonprofit research institute. Sponsors interested in international technology assessments or related studies can provide support through NSF or directly through separate grants or GSA task orders to WTEC. WTEC’s mission is to inform U.S. scientists, engineers, and policymakers of global trends in science and technology. WTEC assessments cover basic research, advanced development, and applications. Panels of typically six technical experts conduct WTEC assessments. Panelists are leading authorities in their field, technically active, and knowledgeable about U.S. and foreign research programs. As part of the assessment process, panels visit and carry out extensive discussions with foreign scientists and engineers in their labs. The WTEC staff helps select topics, recruits expert panelists, arranges study visits to foreign laboratories, organizes workshop presentations, and finally, edits and publishes the final reports. R.D. Shelton is the WTEC point of contact: telephone (717) 299-7130 or email [email protected]. iii Table of Contents Executive Summary ............................................................................................................................... vii 1. Introduction ....................................................................................................................................... 1 Background ................................................................................................................................................. 1 WTEC Background ..................................................................................................................................... 2 Scope of the Study....................................................................................................................................... 2 Methodology of the Study ........................................................................................................................... 3 Overview of the Report ............................................................................................................................... 5 Acknowledgements ..................................................................................................................................... 6 2. Personalized Medicine Manufacturing and Regulation ................................................................ 7 Introduction ................................................................................................................................................. 7 Cell Therapy and Regenerative Medicine: What it is, Why it is Needed, Where it is Headed ..................... 7 The Role of Engineers in Development, Manufacture, and Delivery of Cell Therapy and Regenerative Medicine in Regulated Environments .................................................................................................. 8 Cell Therapy and Regenerative Medicine Efforts in Europe and Asia ....................................................... 10 Conclusions and Feedback for NSF .......................................................................................................... 26 3. Manufacturing of Delivery Systems for Regenerative Medicine ............................................... 29 Introduction ............................................................................................................................................... 29 Considerations for Delivery of Therapeutics ............................................................................................. 29 Manufacturing Techniques ........................................................................................................................ 31 Conclusions ............................................................................................................................................... 35 4. Automated Biomanufacturing and Three-Dimensional Tissue and Organ Fabrication .......... 37 Introduction ............................................................................................................................................... 37 Creation of Professional Ecosystems ......................................................................................................... 37 Translating 3D Printing Technologies into Medical Products ................................................................... 39 Robotic Manufacturing of Cell and Tissue Products: Scale-Up vs. Scale-Out .......................................... 42 Lessons from the Study ............................................................................................................................. 43 A Vision for the Future ............................................................................................................................. 44 5. Biomimetics in Biomanufacturing: Molecular, Cellular, and Tissue-Scale Biomimicry ........... 45 Introduction ............................................................................................................................................... 45 Survey of Worldwide Research Activities ................................................................................................. 45 Current Challenges in Biomimetic Manufacturing .................................................................................... 61 Assessments and Conclusions ................................................................................................................... 66 Concluding Remarks ................................................................................................................................
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