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Workshop on Measurement Needs for Biofabrication of Tissue Engineered Medical Products

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Goal: discuss and identify measurement needs for characterizing biofabricated, tissue engineered medical products for clinical applications.

Scope: Biofabricated tissue-engineered constructs have the potential to transform personalized medicine. However, characterizing these constructs post-fabrication and throughout preclinical use remains challenging. We will hold a 1-day workshop on measurement needs for biofabricated constructs that contain cells, focusing on metrology for the structure of the constructs, cell viability in the constructs, and functional capacity of the constructs. This workshop will enable future research directions, standards development, and the adoption of these constructs for clinical use.

Workshop Report: Babakhanova  G, Simon Jr CG, Romantseva E (2024) Measurement Needs for Biofabrication of Tissue Engineered Medical Products Workshop Report, NIST Special Publication 1500 (NIST SP 1500-23).


Slides and recordings


Thursday, December 1, 2022

11:00 AM11:10 AMWelcome Address: Sheng Lin Gibson, NIST  (Recording)
11:10 AM11:45 AMPlenary: Manufacturing complex biologics for regenerative medicine (Slides | Recording)
Jennifer H. Elisseeff, Johns Hopkins University

Session 1: Cell Viability
Discussion leader: Alicia Henn, BioSpherix

11:55 AM12:05 PMNon-invasive non-contact real-time monitoring of cells within bio-reactors by direct imaging with optical coherence tomography (Slides | Recording)
Naresh Menon, ChromoLogic
12:05 PM12:15 PMNondestructive Cell viability assessment using oxygen imaging (Recording)
Mrignayani Kotecha, O2M Technologies
12:15 PM12:25 PMOptical coherence tomography imaging for label-free measurement of cell viability in scaffolds (Recording)
Carl Simon, NIST
12:25 PM12:55 PMPanel Discussion (Recording)
12:55 PM1:25 PMLunch

Session 2: Cell Phenotype
Discussion leader: Jeff Halpern, University of New Hampshire

1:25 PM1:35 PMAdvancing Drug Discovery with Biofabricated 3D Tissue Models (Recording)
Marc Ferrer, NCATS
1:35 PM1:45 PMProtein Sensing (Slides | Recording)
Marcie Black, Advanced Silicon Group
1:45 PM1:55 PMNon-invasive quantitative live cell imaging (Recording)
Kersti Alm, Phase Holographic Imaging 
1:55 PM2:25 PMPanel Discussion (Recording)
2:25 PM2:35 PMBreak

Session 3: Tissue Characterization
Discussion leader: Nathan Castro, Nanochon Inc.

2:35 PM2:45 PMDielectric spectroscopy for in line monitoring of engineered tissue constructs (Recording)
Rohan Shirwaiker, North Carolina State University
2:45 PM2:55 PMIn situ volumetric imaging and analysis of 3D bioprinted constructs using optical coherence tomography (Recording)
Adam Feinberg, FluidForm
2:55 PM3:05 PMCharacterization of tissue engineered medical products (Slides | Recording)
Bao-Ngoc Nguyen, FDA
3:05 PM3:35 PMPanel Discussion (Recording)
3:35 PM3:45 PMBreak
3:45 PM3:55 PMWorkshop Survey Review, Carl Simon (Recording)
Breakout Session

Topics and Discussion Leaders
1. Potency & phenotype measurements; Richard McFarland, ARMI 
2. Cell viability measurements; Mary Clare McCorry, ARMI
3. Measurements of construct structure; Kimberlee Potter, VA and Leanne Friedrich, NIST
4. pH, O2 & metabolite measurements; Zeeshan Ahmed, NISTand Billyde Brown, GTMI
5. Mechanical property measurements; Callie Higgins, NIST 
6. Sterility measurements; Kirsten Parratt, NIST
7. Measurements of cell distribution in constructs; Taneka Jones, Vericel
8. Measurements of raw materials; Rohan Shirwaiker, NC State University
9. Scaffold reference material; Dawn Henke, Standards Coordinating Body
10. Tissue mimics; Lexi Garcia, ARMI
11. Tissue reference data; Kaiming Ye, Binghamton University
3:55 PM4:35 PMBreakout session

Closing Session

4:35 PM4:55 PMReport back
4:55 PM5:00 PMClosing Remarks
Greta Babakhanova, NIST

Mrignayani Kotecha - President, O2M Technologies

Naresh Menon - CEO, ChromoLogic

Jennifer H. Elisseeff - Professor, Johns Hopkins University

Bao-Ngoc Nguyen - Biomedical Engineer, FDA

Adam Feinberg - CTO, FluidForm

Rohan Shirwaiker - Professor, NC State University

Kersti Alm - CSO, Phase Holographic Imaging

Carl G. Simon, Jr. - Biologist, National Institute of Standards and Technology

Marcie Black - Co-founder & CEO, Advanced Silicon Group

Marc Ferrer - Director, 3D Tissue Bioprinting Laboratory, NCATS

Workshop Steering Committee

First nameLast nameOrganization
GretaBabakhanovaNational Institute of Standards and Technology
CarlSimonNational Institute of Standards and Technology
EugeniaRomantsevaNational Institute of Standards and Technology
LauraPierceNational Institute of Standards and Technology
CallieHigginsNational Institute of Standards and Technology
LeanneFriedrichNational Institute of Standards and Technology
JonathanSeppalaNational Institute of Standards and Technology
JayHoyingAdvanced Solutions
KimberleePotterU.S. Department of Veterans Affairs
Mary ClareMcCorryARMI BioFabUSA
GuillermoAmeerNorthwestern University
JohnHuangTheWell Bioscience, Inc.
Itedale NamroRedwanCELLINK
DawnHenkeStandards Coordinating Body
RohanShirwaikerNC State University
Created September 14, 2022, Updated April 29, 2024