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

  • Artificial Tissues (J Hunsberger, Section Editor)
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Abstract

Purpose of Review

The purpose of this review is to provide perspectives and resources for how cell and tissue manufacturing is being advanced by different stakeholders ranging from government to academia to even at a global scale.

Recent Findings

This perspective article illustrates resources and national efforts that are underway to advance cell and tissue manufacturing. Some of the efforts highlighted are only in their initial years so tangible results are still forthcoming.

Summary

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 topics are discussed: (1) the US National Academies’ Forum on Regenerative Medicine, (2) academic translational programs, (3) development of measurements for regenerative medicine, (4) development of 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. Several insights are provided that may advance the manufacturing of regenerative medicine products in the USA.

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Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Acknowledgements

We would like to acknowledge the keen insights and review from Dr. Robert Lindblad on the PACT program.

Author information

Authors and Affiliations

  1. Regenerative Medicine Manufacturing Society, Greensboro, NC, USA

    Joshua Hunsberger

  2. National Heart, Lung & Blood Institute, National Institutes of Health, Bethesda, MD, USA

    Martha S. Lundberg

  3. Wake Forest Institute for Regenerative Medicine, Wake Forest University, Winston-Salem, NC, USA

    Julie Allickson

  4. Biosystems & Biomaterials Division, National Institute of Standards & Technology, Gaithersburg, MD, USA

    Carl G. Simon Jr

  5. Akron Biotechnology LLC, Boca Raton, FL, USA

    Claudia Zylberberg

  6. National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA

    Sarah H. Beachy

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  1. Joshua Hunsberger
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  2. Martha S. Lundberg
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  4. Carl G. Simon Jr
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  5. Claudia Zylberberg
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  6. Sarah H. Beachy
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Corresponding author

Correspondence to Joshua Hunsberger.

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The authors have no potential conflicts of interest to declare.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Disclaimers

This is an official contribution of the National Institute of Standards and Technology (NIST) and is not subject to copyright in the United States. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIST.

The comments expressed here are those of the authors, and do not reflect official positions of the National Heart, Lung, and Blood Institute or NIH. No funds were provided by the NHLBI for the authorship of this publication.

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Hunsberger, J., Lundberg, M.S., Allickson, J. et al. Examining Resources, Initiatives, and Regulatory Pathways to Advance Regenerative Medicine Manufacturing. Curr Stem Cell Rep 5, 162–172 (2019). https://doi.org/10.1007/s40778-019-00163-0

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