Goddard Eliza, Dodds Susan
ARC Centre of Excellence for Electromaterials Science, Humanities and Social Sciences, La Trobe University, Melbourne, VIC, Australia.
ARC Centre of Excellence for Electromaterials Science, Office of the Deputy Vice-Chancellor (Research and Industry Engagement), La Trobe University, Melbourne, VIC, Australia.
Methods Mol Biol. 2020;2140:43-64. doi: 10.1007/978-1-0716-0520-2_4.
3D bioprinting involves engineering live cells into a 3D structure, using a 3D printer to print cells, often together with a compatible 3D scaffold. 3D-printed cells and tissues may be used for a range of purposes including medical research, in vitro drug testing, and in vivo transplantation. The inclusion of living cells and biomaterials in the 3D printing process raises ethical, policy, and regulatory issues at each stage of the bioprinting process that include the source of cells and materials, stability and biocompatibility of cells and materials, disposal of 3D-printed materials, intended use, and long-term effects. This chapter focuses on the ethical issues that arise from 3D bioprinting in the lab-from consideration of the source of cells and materials, ensuring their quality and safety, through to testing of bioprinted materials in animal and human trials. It also provides guidance on where to seek information concerning appropriate regulatory frameworks and guidelines, including on classification and patenting of 3D-bioprinted materials, and identifies regulatory gaps that deserve attention.
3D生物打印涉及将活细胞构建成三维结构，使用3D打印机打印细胞，通常还会与兼容的3D支架一起打印。3D打印的细胞和组织可用于一系列目的，包括医学研究、体外药物测试和体内移植。在3D打印过程中纳入活细胞和生物材料，在生物打印过程的每个阶段都会引发伦理、政策和监管问题，这些问题包括细胞和材料的来源、细胞和材料的稳定性及生物相容性、3D打印材料的处置、预期用途以及长期影响。本章重点关注实验室中3D生物打印引发的伦理问题——从细胞和材料来源的考量，确保其质量和安全，到在动物和人体试验中对生物打印材料进行测试。它还就何处可获取有关适当监管框架和指南的信息提供指导，包括3D生物打印材料的分类和专利方面的信息，并指出值得关注的监管空白。
