再生医学制造的产业驱动路线图
An Industry-Driven Roadmap for Manufacturing in Regenerative Medicine.
机构信息
Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, North Carolina, USA.
出版信息
Stem Cells Transl Med. 2018 Aug;7(8):564-568. doi: 10.1002/sctm.18-0060. Epub 2018 Jul 15.
Abstract
Regenerative medicine is poised to become a significant industry within the medical field. As such, the development of strategies and technologies for standardized and automated regenerative medicine clinical manufacturing has become a priority. An industry-driven roadmap toward industrial scale clinical manufacturing was developed over a 3-year period by a consortium of companies with significant investment in the field of regenerative medicine. Additionally, this same group identified critical roadblocks that stand in the way of advanced, large-scale regenerative medicine clinical manufacturing. This perspective article details efforts to reach a consensus among industry stakeholders on the shortest pathway for providing access to regenerative medicine therapies for those in need, both within the United States and around the world. Stem Cells Translational Medicine 2018;7:564-568.
摘要
再生医学有望成为医学领域的一个重要产业。因此，制定标准化和自动化再生医学临床制造的策略和技术已成为当务之急。一个由在再生医学领域有大量投资的公司组成的联盟在三年内制定了一条通向工业规模临床制造的行业驱动路线图。此外，同一组还确定了先进的、大规模的再生医学临床制造面临的关键障碍。本文详细介绍了如何在行业利益相关者之间达成共识，找到为美国乃至全球有需要的人提供再生医学疗法的最短途径。《干细胞转化医学》2018 年；7：564-568。
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