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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). https://doi.org/10.6028/NIST.SP.1500-23
Slides and recordings
TECHNICAL PROGRAM | ||
Thursday, December 1, 2022 | ||
| 11:00 AM | 11:10 AM | Welcome Address: Sheng Lin Gibson, NIST (Recording) |
| 11:10 AM | 11:45 AM | Plenary: Manufacturing complex biologics for regenerative medicine (Slides | Recording) Jennifer H. Elisseeff, Johns Hopkins University |
Session 1: Cell Viability | ||
| 11:55 AM | 12:05 PM | Non-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 PM | 12:15 PM | Nondestructive Cell viability assessment using oxygen imaging (Recording) Mrignayani Kotecha, O2M Technologies |
| 12:15 PM | 12:25 PM | Optical coherence tomography imaging for label-free measurement of cell viability in scaffolds (Recording) Carl Simon, NIST |
| 12:25 PM | 12:55 PM | Panel Discussion (Recording) |
| 12:55 PM | 1:25 PM | Lunch |
Session 2: Cell Phenotype | ||
| 1:25 PM | 1:35 PM | Advancing Drug Discovery with Biofabricated 3D Tissue Models (Recording) Marc Ferrer, NCATS |
| 1:35 PM | 1:45 PM | Protein Sensing (Slides | Recording) Marcie Black, Advanced Silicon Group |
| 1:45 PM | 1:55 PM | Non-invasive quantitative live cell imaging (Recording) Kersti Alm, Phase Holographic Imaging |
| 1:55 PM | 2:25 PM | Panel Discussion (Recording) |
| 2:25 PM | 2:35 PM | Break |
Session 3: Tissue Characterization | ||
| 2:35 PM | 2:45 PM | Dielectric spectroscopy for in line monitoring of engineered tissue constructs (Recording) Rohan Shirwaiker, North Carolina State University |
| 2:45 PM | 2:55 PM | In situ volumetric imaging and analysis of 3D bioprinted constructs using optical coherence tomography (Recording) Adam Feinberg, FluidForm |
| 2:55 PM | 3:05 PM | Characterization of tissue engineered medical products (Slides | Recording) Bao-Ngoc Nguyen, FDA |
| 3:05 PM | 3:35 PM | Panel Discussion (Recording) |
| 3:35 PM | 3:45 PM | Break |
| 3:45 PM | 3:55 PM | Workshop 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 PM | 4:35 PM | Breakout session |
Closing Session | ||
| 4:35 PM | 4:55 PM | Report back |
| 4:55 PM | 5:00 PM | Closing 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 name | Last name | Organization |
| Greta | Babakhanova | National Institute of Standards and Technology |
| Carl | Simon | National Institute of Standards and Technology |
| Eugenia | Romantseva | National Institute of Standards and Technology |
| Laura | Pierce | National Institute of Standards and Technology |
| Callie | Higgins | National Institute of Standards and Technology |
| Leanne | Friedrich | National Institute of Standards and Technology |
| Jonathan | Seppala | National Institute of Standards and Technology |
| Jay | Hoying | Advanced Solutions |
| Kimberlee | Potter | U.S. Department of Veterans Affairs |
| Mary Clare | McCorry | ARMI BioFabUSA |
| Guillermo | Ameer | Northwestern University |
| John | Huang | TheWell Bioscience, Inc. |
| Itedale Namro | Redwan | CELLINK |
| Dawn | Henke | Standards Coordinating Body |
| Taneka | Jones | Vericel |
| Marian | Piekarczyk | Thermofisher |
| Rohan | Shirwaiker | NC State University |