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

Joshua Hunsberger, Martha S. Lundberg, Julie Allickson, Carl G. Simon, Claudia Zylberberg, Sarah H. Beachy

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)162-172
Number of pages11
JournalCurrent Stem Cell Reports
Issue number4
StatePublished - Dec 1 2019


  • Automation
  • Biomanufacturing
  • Clinical translation
  • Regenerative medicine
  • Standards

ASJC Scopus subject areas

  • Molecular Biology
  • Genetics
  • Developmental Biology
  • Cell Biology


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