Working Group Spotlight: Characterization of Fiber-Based Scaffolds
The efforts of the SCB-coordinated Characterization of Fiber-Based Scaffolds project working group recently resulted in the publication of ASTM F3510 – 21: Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products.
About the Working Group
“Participating in working groups provides a rare opportunity for candid discussions about the strengths and weaknesses of measurements or technologies. I like learning how experts in a technology think about product characterization and development. These discussions are key for developing a strategy that is thorough, yet practical, affordable, and achievable.”
The working group for this standard emerged from a 120-participant workshop convened in 2018 by NIST, ARMI | BioFabUSA, and ASTM International Committee F04 on Medical and Surgical Materials and Devices. The working group consists of approximately 35 stakeholders from academia, government, and industry, including suppliers, tissue-engineered medical product (TEMP) manufacturers, and representatives from NIST.
The Challenge
The structural, mechanical, and biological properties of fiber-based scaffolds are subject to a wide range of variables that can change how they interact with cells, impacting their quality and safety. However, many of these critical characteristics are measured in different ways from lab to lab. Stakeholders lacked a common approach to fiber-based scaffold characterization assays to ensure comparable, reproduceable data and quality products.
Accomplishments: A Published Standard
The working group’s efforts served to accelerate the progress of the standard through the ASTM development process, which included initial drafting of the standard and successive rounds of revision to ensure that the standard reflected the consensus opinions of experts in the field. Looking ahead, SCB and members of the working group plan to support its implementation and raise awareness of the standard in the community.
Why it Matters
The standard will help to:
Ensure the potency and functionality of cells within fiber-based scaffolds
Increase the consistency in properties of fiber-based scaffolds, making it more feasible to manufacture them at scale and increasing their quality, reliability, and effectiveness
Improve efficiency for organizations developing TEMPs by reducing the need to spend time and resources discovering optimal test methods
Get Involved
Now that the standard has been published, the fiber-based scaffolds working group is no longer actively meeting. A related effort focused on standards for cell viability in scaffolds is currently in the early stages and accepting new working group members. Anyone interested in joining this new effort or other related standards efforts should contact SCB.