On the reproducibility of extrusion-based bioprinting: round robin study on standardization in the field

Abstract

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.

Advanced optical assessment and modeling of extrusion bioprinting

“…An example is the round-robin study conducted by Garces et al, which involved 15 international groups. The aim was to analyze reproducibility and introduce standards to the bioprinting field in order to accelerate the transition from laboratory practice to production for clinical applications 34 . They concluded that automated image analysis (IA) is a suitable tool for assessing printing process reproducibility, but quantitative comparability in the bioprinting field has not yet been achieved due to lack of standardization in terms of bioprinting equipment.…”

3D bioprinting in bioremediation: a comprehensive review of principles, applications, and future directions

“…Moreover, the digital nature of 3D printing ensures reproducibility, allowing for the consistent manufacture of bioremediation devices across different locations ( Thompson et al, 2016 ). Recent research has identified key factors that can be improved to enhance the reproducibility and reliability of bioprinting, which holds great potential for future applications ( Grijalva Garces et al, 2024 ).…”

The Past, Present, and Future of Tubular Melt Electrowritten Constructs to Mimic Small Diameter Blood Vessels – A Stable Process?

“…On the other hand, MEW removes the buckling instabilities present in SES, greatly improving the reproducibility of desired geometries [ 130,134,135 ] with even less engineering effort than most customized SES setups would require. [ 135 ] Enhancing the stability of SES to be more independent of fiber placement and atmospheric conditions [ 136–138 ] is integral for medical device manufacturing, [ 139 ] which melt‐based systems demonstrate to be less affected by. [ 140,141 ] MEW being a stable process holds especially true for the fabrication of micro‐sized, porous structures with highly defined architecture and hierarchy in both, the planar and tubular category and beyond.…”