A critical component of many tissue‐engineered medical products (TEMPs) is the scaffold or biomaterial. The industry's understanding of scaffold properties and their influence on cell behavior has advanced, but our technical capability to reliably characterize scaffolds requires improvement, especially to enable large‐scale manufacturing. In response to the key findings from the 2013 ASTM International Workshop of Standards and Measurements for Tissue Engineering Scaffolds, the National Institute of Standards and Technology (NIST), ASTM International, BiofabUSA, and the Standards Coordinating Body (SCB) organized a workshop in 2018 titled, “Characterization of Fiber‐Based Scaffolds”. The goal was to convene a group of 40 key industry stakeholders to identify major roadblocks in measurements of fiber‐based scaffold properties. This report provides an overview of the findings from this collaborative workshop. The four major consensus findings were that (a) there is need for a documentary standard guide that would aid developers in the selection of test methods for characterizing fiber‐based scaffolds; (b) there is a need for a strategy to assess the quality of porosity and pore size measurements, which could potentially be ameliorated by the development of a reference material; (b) there are challenges with the lexicon used to describe and assess scaffolds; and (d) the vast array of product applications makes it challenging to identify consensus test methods. As a result of these findings, a working group was formed to develop an ASTM Standard Guide for Characterizing Fiber‐Based Constructs that will provide developers guidance on selecting measurements for characterizing fiber‐based scaffolds.

中文翻译：

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纤维基支架表征研讨会：挑战、进展和未来方向。

许多组织工程医疗产品 (TEMP) 的一个关键组成部分是支架或生物材料。业界对支架特性及其对细胞行为影响的理解有所进步，但我们可靠表征支架的技术能力需要改进，尤其是要实现大规模制造。为响应 2013 年 ASTM 国际组织工程支架标准和测量研讨会的主要发现，美国国家标准与技术研究所 (NIST)、ASTM International、BiofabUSA 和标准协调机构 (SCB) 于 2018 年组织了一次研讨会题为“基于纤维的支架的表征”。目标是召集一个由 40 个主要行业利益相关者组成的小组，以确定测量基于纤维的支架特性的主要障碍。本报告概述了此次合作研讨会的调查结果。四个主要的共识发现是 (a) 需要一个文件标准指南，以帮助开发人员选择表征纤维基支架的测试方法；(b) 需要一种评估孔隙率和孔径测量质量的策略，这可能会通过开发参考材料而得到改善；(b) 用于描述和评估支架的词汇存在挑战；(d) 大量的产品应用使得确定一致的测试方法具有挑战性。由于这些发现，