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Custom Engineered Tissue Culture Molds from Laser-etched Masters
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Tissue Engineering Measurands.

Deepika Arora1, Greta Babakhanova1, Carl G Simon1

  • 1Biosystems & Biomaterials Division, National Institute of Standards & Technology, Gaithersburg, Maryland 20899, United States.

ACS Biomaterials Science & Engineering
|December 15, 2020
PubMed
Summary
This summary is machine-generated.

Improving communication in tissue engineered medical products (TEMPs) characterization is crucial. A metrological perspective and measurand charts clarify assumptions, enhancing strategic planning for safe and effective product development.

Keywords:
biocompatibilitycell viabilitymeasurandmeasurementmetrologypotencyscaffoldstandardstissue engineering

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Area of Science:

  • Biomedical Engineering
  • Metrology
  • Regenerative Medicine

Background:

  • Characterizing tissue engineered medical products (TEMPs) involves numerous measurements to ensure safety and efficacy.
  • Miscommunication frequently arises during TEMP characterization due to unstated assumptions about measurements.
  • A standardized approach is needed to improve clarity and coherence in discussions about TEMP properties.

Purpose of the Study:

  • To introduce a metrological perspective for enhancing communication in TEMP characterization.
  • To propose the use of a "measurand chart" to clarify assumptions about measurements.
  • To refine the understanding and definition of measurands in tissue engineering.

Main Methods:

  • Discussing TEMP characterization through the lens of metrology, focusing on the definition of measurands.
  • Utilizing three case studies: cell viability in a scaffold, potency, and biocompatibility.
  • Exploring concepts such as measurement models and definitional uncertainty.

Main Results:

  • A "measurand chart" can effectively clarify assumptions, fostering more coherent discussions on the value of specific measurements.
  • Defining tissue engineering measurands and addressing definitional uncertainty are key to improving communication.
  • The metrological framework provides a structured way to think about TEMP measurements.

Conclusions:

  • Adopting a metrological perspective enhances strategic thinking and communication in TEMP development.
  • Clearer definitions and explicit assumptions regarding measurands lead to more purposeful product characterization plans.
  • Improved communication through metrology supports the successful development and release of TEMPs.