Institute of Functional Interfaces, Karlsruhe Institute of Technology, Eggenstein-Leopoldshafen, Germany.
Institute of Process Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe Institute of Technology, Karlsruhe, Germany.
Biofabrication. 2023 Oct 11;16(1). doi: 10.1088/1758-5090/acfe3b.
The outcome of three-dimensional (3D) bioprinting heavily depends, amongst others, on the interaction between the developed bioink, the printing process, and the printing equipment. However, if this interplay is ensured, bioprinting promises unmatched possibilities in the health care area. To pave the way for comparing newly developed biomaterials, clinical studies, and medical applications (i.e. printed organs, patient-specific tissues), there is a great need for standardization of manufacturing methods in order to enable technology transfers. Despite the importance of such standardization, there is currently a tremendous lack of empirical data that examines the reproducibility and robustness of production in more than one location at a time. In this work, we present data derived from a round robin test for extrusion-based 3D printing performance comprising 12 different academic laboratories throughout Germany and analyze the respective prints using automated image analysis (IA) in three independent academic groups. The fabrication of objects from polymer solutions was standardized as much as currently possible to allow studying the comparability of results from different laboratories. This study has led to the conclusion that current standardization conditions still leave room for the intervention of operators due to missing automation of the equipment. This affects significantly the reproducibility and comparability of bioprinting experiments in multiple laboratories. Nevertheless, automated IA proved to be a suitable methodology for quality assurance as three independently developed workflows achieved similar results. Moreover, the extracted data describing geometric features showed how the function of printers affects the quality of the printed object. A significant step toward standardization of the process was made as an infrastructure for distribution of material and methods, as well as for data transfer and storage was successfully established.
三维（3D）生物打印的结果在很大程度上取决于生物墨水的开发、打印过程和打印设备之间的相互作用。然而，如果这种相互作用得到保证，生物打印将在医疗保健领域提供无与伦比的可能性。为了为新开发的生物材料、临床研究和医疗应用（即打印器官、患者特异性组织）铺平道路，非常需要标准化制造方法，以实现技术转让。尽管这种标准化很重要，但目前缺乏同时在多个地点检查生产可重复性和稳健性的经验数据。在这项工作中，我们展示了来自基于挤出的 3D 打印性能的轮次测试的数据，该测试包括德国 12 个不同的学术实验室，并使用三个独立的学术小组的自动图像分析（IA）分析各自的打印件。聚合物溶液的物体制造尽可能标准化，以允许研究来自不同实验室的结果的可比性。这项研究得出的结论是，由于设备缺少自动化，当前的标准化条件仍然允许操作人员进行干预。这会严重影响多个实验室中生物打印实验的可重复性和可比性。然而，自动 IA 被证明是一种合适的质量保证方法，因为三个独立开发的工作流程实现了相似的结果。此外，描述几何特征的数据表明，打印机的功能如何影响打印物体的质量。由于成功建立了材料和方法的分发基础设施，以及数据传输和存储基础设施，因此在该过程的标准化方面迈出了重要的一步。
