Measurement Needs for Biofabrication of Tissue Engineered Medical Products Workshop Report

Published

April 19, 2024

Author(s)

Greta Babakhanova, Carl Simon Jr., Eugenia Romantseva

Abstract

Biofabricated tissue-engineered constructs have the potential to transform personalized medicine. However, characterizing these constructs post-fabrication and throughout preclinical use remains challenging. On December 1, 2022, the National Institute of Standards and Technology (NIST) held a one-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. The workshop on measurement needs for biofabrication of tissue engineered medical products aimed to enable future research directions, standards development, and the adoption of these constructs for clinical use. The virtual workshop convened over 180 participants and represented academia, government and industry sectors. The attendees focused on discussing and identifying measurement needs for characterizing biofabricated, tissue engineered medical products (TEMPs) for clinical applications. The workshop reviled that the field of biomanufacturing finds itself in a nascent stage characterized by destructive, labor-intensive methods. The unanimous call for non-destructive, accurate viability and functionality characterization highlights a pivotal need for innovation. Simultaneously, there is a mounting demand for standardized testing, parameters, and reference materials, coupled with application-specific standards for different cell types and overall manufacturing processes. The establishment of collaborative consortiums is advocated to foster knowledge sharing and effective integration of technologies. The identified challenges in consistency and repeatability underscore the pressing need for reproducibility, robust measurement techniques, and interdisciplinary collaborations in biomanufacturing. Additionally, the pivotal role of systems capturing diverse measurements, the preference for minimally invasive sensors, and efforts towards miniaturization of clinical technologies for lab use collectively propel the field towards a progressive and multidimensional approach for tissue characterization. The unanimous support for the collection, validation, and standardization of reference data, with the proposal of a central data portal, signifies a concerted effort towards enhancing the reliability and accessibility of crucial information in the field.

Citation

Special Publication (NIST SP) - 1500-23

Report Number

1500-23

NIST Pub Series

Special Publication (NIST SP)

Pub Type

NIST Pubs

Download Paper

https://doi.org/10.6028/NIST.SP.1500-23

Local Download

Keywords

Biofabrication, regenerative medicine, tissue engineered medical products (TEMPs), standards, measurement needs, workshop report.

Citation

Babakhanova, G. , Simon Jr., C. and Romantseva, E. (2024), Measurement Needs for Biofabrication of Tissue Engineered Medical Products Workshop Report, Special Publication (NIST SP), National Institute of Standards and Technology, Gaithersburg, MD, [online], https://doi.org/10.6028/NIST.SP.1500-23, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=957267 (Accessed May 3, 2024)