Ye Kaiming, Kaplan David L, Bao Gang, Bettinger Christopher, Forgacs Gabor, Dong Cheng, Khademhosseini Ali, Ke Yonggang, Leong Kam, Sambanis Athanassios, Sun Wei, Yin Peng
Department of Biomedical Engineering, Center of Biomanufacturing for Regenerative Medicine, Watson School of Engineering and Applied Science, Binghamton University, State University of New York (SUNY), Binghamton, New York 13902, United States.
Department of Biomedical Engineering, School of Engineering, Tufts University, Medford, Massachusetts 02155, United States.
ACS Biomater Sci Eng. 2018 Jul 9;4(7):2292-2307. doi: 10.1021/acsbiomaterials.8b00650. Epub 2018 Jun 19.
This position paper assesses state-of-the-art advanced biomanufacturing and identifies paths forward to advance this emerging field in biotechnology and biomedical engineering, including new research opportunities and translational and corporate activities. The vision for the field is to see advanced biomanufacturing emerge as a discipline in academic and industrial communities as well as a technological opportunity to spur research and industry growth. To navigate this vision, the paths to move forward and to identify major barriers were a focal point of discussions at a National Science Foundation-sponsored workshop focused on the topic. Some of the major needs include but are not limited to the integration of specific scientific and engineering disciplines and guidance from regulatory agencies, infrastructure requirements, and strategies for reliable systems integration. Some of the recommendations, major targets, and opportunities were also outlined, including some "grand challenges" to spur interest and progress in the field based on the participants at the workshop. Many of these recommendations have been expanded, materialized, and adopted by the field. For instance, the formation of an initial collaboration network in the community was established. This report provides suggestions for the opportunities and challenges to help move the field of advanced biomanufacturing forward. The field is in the early stages of effecting science and technology in biomanufacturing with a bright and important future impact evident based on the rapid scientific advances in recent years and industry progress.
本立场文件评估了先进生物制造的最新技术水平，并确定了推动生物技术和生物医学工程这一新兴领域发展的前进道路，包括新的研究机会以及转化和企业活动。该领域的愿景是使先进生物制造在学术和工业界成为一门学科，并成为推动研究和产业增长的技术机遇。为实现这一愿景，前进的道路以及识别主要障碍是美国国家科学基金会主办的一次聚焦该主题的研讨会上讨论的重点。一些主要需求包括但不限于特定科学和工程学科的整合、监管机构的指导、基础设施要求以及可靠系统集成的策略。还概述了一些建议、主要目标和机遇，包括基于研讨会上的参与者提出的一些“重大挑战”，以激发该领域的兴趣并推动其进步。这些建议中的许多已得到该领域的扩展、落实和采纳。例如，在该领域建立了最初的合作网络。本报告针对机遇和挑战提出了建议，以帮助推动先进生物制造领域向前发展。基于近年来的快速科学进展和产业进步，该领域在生物制造领域实现科学技术应用尚处于早期阶段，但其未来影响光明且重大。
