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      An Industry‐Driven Roadmap for Manufacturing in Regenerative Medicine

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          Summary

          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. S tem C ells T ranslational M edicine 2018;7:564–568

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          Scalable stirred suspension culture for the generation of billions of human induced pluripotent stem cells using single-use bioreactors

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            Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine.

            A novel manufacturing industry is emerging to translate unique cellular therapy bioprocesses to robust, scaled manufacturing production for successful clinical translation.
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              Manufacturing road map for tissue engineering and regenerative medicine technologies.

              The Regenerative Medicine Foundation Annual Conference held on May 6 and 7, 2014, had a vision of assisting with translating tissue engineering and regenerative medicine (TERM)-based technologies closer to the clinic. This vision was achieved by assembling leaders in the field to cover critical areas. Some of these critical areas included regulatory pathways for regenerative medicine therapies, strategic partnerships, coordination of resources, developing standards for the field, government support, priorities for industry, biobanking, and new technologies. The final day of this conference featured focused sessions on manufacturing, during which expert speakers were invited from industry, government, and academia. The speakers identified and accessed roadblocks plaguing the field where improvements in advanced manufacturing offered many solutions. The manufacturing sessions included (a) product development toward commercialization in regenerative medicine, (b) process challenges to scale up manufacturing in regenerative medicine, and (c) infrastructure needs for manufacturing in regenerative medicine. Subsequent to this, industry was invited to participate in a survey to further elucidate the challenges to translation and scale-up. This perspective article will cover the lessons learned from these manufacturing sessions and early results from the survey. We also outline a road map for developing the manufacturing infrastructure, resources, standards, capabilities, education, training, and workforce development to realize the promise of TERM.
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                Author and article information

                Contributors
                jhunsber@wakehealth.edu
                Journal
                Stem Cells Transl Med
                Stem Cells Transl Med
                10.1002/(ISSN)2157-6580
                SCT3
                Stem Cells Translational Medicine
                John Wiley & Sons, Inc (Hoboken, USA )
                2157-6564
                2157-6580
                15 July 2018
                August 2018
                : 7
                : 8 ( doiID: 10.1002/sct3.2018.7.issue-8 )
                : 564-568
                Affiliations
                [ 1 ] Wake Forest Institute for Regenerative Medicine, Wake Forest University Winston‐Salem North Carolina USA
                Author notes
                [*] [* ]Correspondence: Joshua G. Hunsberger, Ph.D., Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston‐Salem, North Carolina, USA. Telephone: (336) 713-7279; e‐mail: jhunsber@ 123456wakehealth.edu
                Author information
                http://orcid.org/0000-0002-8683-6129
                Article
                SCT312323
                10.1002/sctm.18-0060
                6090514
                30009571
                712f7b92-cde8-4a88-9bf5-cba27ce96e79
                © 2018 The Authors S tem C ells T ranslational M edicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 16 March 2018
                : 19 April 2018
                Page count
                Figures: 0, Tables: 2, Pages: 6, Words: 3859
                Categories
                Manufacturing for Regenerative Medicine
                Not Applicable
                Not Applicable
                Perspectives
                Perspectives
                Custom metadata
                2.0
                sct312323
                August 2018
                Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.4.4 mode:remove_FC converted:14.08.2018

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