Establishing a current good manufacturing practice facility for biomaterials and biomolecules in an academic medical center

Alexandra J. Greenberg-Worisek, Bethany Kinseth Runge, Sarah A. Solyntjes, Juliana Helene-Kraft, Suzanne L. Glass, Brian E. Waletzki, James L. Herrick, Alan Lee Miller, Michael J Yaszemski, Anthony John Windebank, Huan D Wang

Research output: Contribution to journalReview article

Abstract

A major hurdle in translating biomaterial-based products is moving from the laboratory into first-in-human trials. For many investigators, this is difficult to achieve without industry assistance. A biomaterials facility that follows current good manufacturing practices (cGMPs) in an academic medical center would potentially accelerate the process of translating biomedical products to first-in-human trials. This article details the establishment of Mayo Clinic's Biomaterials and Biomolecules cGMP facility and the challenges encountered in creating a manufacturing facility in an academic medical setting. The facility functions as a platform for manufacturing and as a resource for guiding investigators from discovery through translation. The success of the facility relies on addressing challenges associated with balancing the volume of requests for cGMP services and the facility's capacity by prioritizing projects in the pipeline. In addition, we will educate researchers regarding the methodologies used in carrying out their preclinical projects such that the data generated are appropriate to support an Investigational Device Exemption application to the Food and Drug Administration. This article describes the feasibility and path to establishing a current good manufacturing practice biomaterial facility in an academic medical center. It presents a solution to overcome the "Valley of Death" in bench to bedside translation of biomaterials-based medical devices. It sets a good and feasible example to those who are interested in joining the path toward clinical practice/commercialization, and helps to spur other institutions and investigators to think about how they could incorporate in-house processes and facilities to help speed up the translation of their work into first-in-human trials.

Original languageEnglish (US)
Pages (from-to)493-498
Number of pages6
JournalTissue Engineering - Part B: Reviews
Volume24
Issue number6
DOIs
StatePublished - Dec 1 2018

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Biocompatible Materials
Biomolecules
Biomaterials
Research Personnel
Equipment and Supplies
Critical Pathways
United States Food and Drug Administration
Industry
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Keywords

  • academic center
  • biomaterials
  • cGMP
  • regulatory
  • translation

ASJC Scopus subject areas

  • Bioengineering
  • Biomaterials
  • Biochemistry
  • Biomedical Engineering

Cite this

Establishing a current good manufacturing practice facility for biomaterials and biomolecules in an academic medical center. / Greenberg-Worisek, Alexandra J.; Runge, Bethany Kinseth; Solyntjes, Sarah A.; Helene-Kraft, Juliana; Glass, Suzanne L.; Waletzki, Brian E.; Herrick, James L.; Miller, Alan Lee; Yaszemski, Michael J; Windebank, Anthony John; Wang, Huan D.

In: Tissue Engineering - Part B: Reviews, Vol. 24, No. 6, 01.12.2018, p. 493-498.

Research output: Contribution to journalReview article

Greenberg-Worisek, Alexandra J. ; Runge, Bethany Kinseth ; Solyntjes, Sarah A. ; Helene-Kraft, Juliana ; Glass, Suzanne L. ; Waletzki, Brian E. ; Herrick, James L. ; Miller, Alan Lee ; Yaszemski, Michael J ; Windebank, Anthony John ; Wang, Huan D. / Establishing a current good manufacturing practice facility for biomaterials and biomolecules in an academic medical center. In: Tissue Engineering - Part B: Reviews. 2018 ; Vol. 24, No. 6. pp. 493-498.
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