Workshop on the characterization of fiber-based scaffolds: Challenges, progress, and future directions.

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.

许多组织工程医疗产品（TEMPs）的一个关键组成部分是支架或生物材料。该行业对支架特性及其对细胞行为影响的理解已经有所进步，但我们可靠地描述支架特性的技术能力需要提高，特别是为了实现大规模生产。针对2013年美国材料与试验协会（ASTM International）组织的组织工程支架标准与测量研讨会的主要研究结果，美国国家标准与技术研究院（NIST）、美国材料与试验协会、美国生物制造公司（BiofabUSA）以及标准协调机构（SCB）在2018年组织了一次名为“纤维基支架的特性描述”的研讨会。其目的是召集40名关键的行业利益相关者，以确定在测量纤维基支架特性方面的主要障碍。本报告概述了这次合作研讨会的研究结果。四个主要的共识性研究结果是：（a）需要一份文献标准指南，以帮助研发人员选择用于描述纤维基支架特性的测试方法；（b）需要一种评估孔隙率和孔径测量质量的策略，这可能通过开发一种参考材料得到改善；（b）用于描述和评估支架的词汇存在问题；（d）大量的产品应用使得确定共识性测试方法具有挑战性。基于这些研究结果，成立了一个工作组来制定一份用于描述纤维基构建体特性的美国材料与试验协会标准指南，该指南将为研发人员选择用于描述纤维基支架特性的测量方法提供指导。