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PUBLICATIONS

Examining Resources, Initiatives, and Regulatory Pathways to Advance Regenerative Medicine Manufacturing

Published

Author(s)

Joshua Hunsberger, Martha Lundberg, Julie Allickson, Claudia Zylberberg, Sarah Beachy, Carl Simon

Abstract

This perspective article is inspired by a workshop entitled "Cell and Tissue Manufacturing Innovation" that was held at the Tissue Engineering and Regenerative medicine Society (TERMIS). Five main concepts are discussed: 1) the US National Academies' Forum on Regenerative Medicine, 2) academic translational programs, 3) developing measurements for regenerative medicine, 4) developing standards for ancillary materials and 5) the global landscape for accelerating regenerative medicine manufacturing. Concepts are presented with current perspective and key insights on challenges, opportunities and next steps for cell and tissue manufacturing innovation.
Citation
Cytotherapy
Pub Type
Journals

Download Paper

https://doi.org/10.1007/s40778-019-00163-0
Local Download

Keywords

tissue engineering, regenerative medicine, documentary standards, biomanufacturing
Standards, Manufacturing quality assurance, Manufacturing, Bioscience, Biomaterials and Biomanufacturing

Citation

Hunsberger, J. , Lundberg, M. , Allickson, J. , Zylberberg, C. , Beachy, S. and Simon, C. (2019), Examining Resources, Initiatives, and Regulatory Pathways to Advance Regenerative Medicine Manufacturing, Cytotherapy, [online], https://doi.org/10.1007/s40778-019-00163-0, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=928015 (Accessed October 13, 2025)

Issues

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Created August 8, 2019, Updated September 29, 2025
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