TY - JOUR

T1 - On the reproducibility of extrusion-based bioprinting

T2 - round robin study on standardization in the field

AU - Grijalva Garces, David

AU - Strauß, Svenja

AU - Gretzinger, Sarah

AU - Schmieg, Barbara

AU - Jüngst, Tomasz

AU - Groll, Jürgen

AU - Meinel, Lorenz

AU - Schmidt, Isabelle

AU - Hartmann, Hanna

AU - Schenke-Layland, Katja

AU - Brandt, Nico

AU - Selzer, Michael

AU - Koltay, Peter

AU - Southan, Alexander

AU - Tovar, Günter E.M.

AU - Schmidt, Sarah

AU - Weber, Achim

AU - Ahlfeld, Tilman

AU - Gelinsky, Michael

AU - Scheibel, Thomas

AU - Detsch, Rainer

AU - Boccaccini, Aldo R.

AU - Naolou, Toufik

AU - Lee-Thedieck, Cornelia

AU - Willems, Christian

AU - Groth, Thomas

AU - Allgeier, Stephan

AU - Köhler, Bernd

AU - Friedrich, Tiaan

AU - Briesen, Heiko

AU - Buchholz, Janine

AU - Paulus, Dietrich

AU - von Gladiss, Anselm

AU - Hubbuch, Jürgen

AU - Zimmermann, Stefan

N1 - he organizing laboratory, Institute of Functional Interfaces of the Karlsruhe Institute of Technology received funding from the Federal Ministry of Education and Research (BMBF) as Project SOP_Bioprint under Contract Number 13XP5071B for the Round robin—3D printing and Round robin—image analysis tests. The development of the Bioprinting Fidelity Imager (BioFI) imaging system by the Department of Microsystems Engineering of the University of Freiburg, Germany, and Hahn-Schickard-Gesellschaft für angewandte Forschung e.V. was supported by the Federal Ministry of Education and Research (BMBF) under the Contract Numbers 02P20E020 and 02P20E021.

PY - 2023/10/11

Y1 - 2023/10/11

N2 - 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.

AB - 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.

KW - 3D printing

KW - bioink

KW - extrusion-based bioprinting

KW - reproducibility

KW - round robin

KW - technology transfer

UR - http://www.scopus.com/inward/record.url?scp=85173621383&partnerID=8YFLogxK

U2 - 10.1088/1758-5090/acfe3b

DO - 10.1088/1758-5090/acfe3b

M3 - Article

C2 - 37769669

AN - SCOPUS:85173621383

VL - 16

JO - BIOFABRICATION

JF - BIOFABRICATION

SN - 1758-5082

IS - 1

M1 - 015002

ER -