Three-Dimensional Bioprinting: Safety, Ethical, and Regulatory Considerations

Abstract

Three-dimensional (3D) bioprinting of tissues or organs holds great potential for several clinical applications in the future. Similar to all new biotechnologies, 3D bioprinting possesses both benefits and risks. Consequently, several ethical, safety, and regulatory issues have to be addressed. Ethical concerns identified involve the ownership of prototypes, harvesting and type of cells and biomaterials, research as well as commercialization of produced constructs. Safety concerns identified are linked to the biocompatibility of bioinks, ex vivo manipulation of cells, and maintenance of aseptic conditions. Regulations are vague and are under the provisions made for tissue engineering. Three-dimensional bioprinting should be considered beyond a conceptual therapy; it would require ethical oversight and the introduction of a robust regulatory framework.