Cell Processing for 3D Bioprinting: Quality Requirements for Quality Assurance in Fundamental Research and Translation
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Bioprinting is an additive manufacturing process where biomaterials-based inks are printed layer-by-layer to create three-dimensional (3D) structures that mimic natural tissues. Quality assurance for 3D bioprinting is paramount to undertaking fundamental research and preclinical and clinical product development. It forms part of quality management and is vital to reproducible and safe tissue fabrication, function, and regulatory approval for translational application. This chapter seeks to place the implementation of quality practices in 3D bioprinting front-of-mind, with emphasis on cell processing, although important to all components and procedures of the printing pipeline.
Key words3D bioprinting Cells Quality assurance Quality management system Good laboratory practice Good manufacturing practice Clinical compliance
The author wishes to acknowledge funding from the Australian Research Council (ARC) Centre of Excellence Scheme (CE140100012).
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