Genotoxicity and mutagenicity testing of biomaterials

Abstract

Rapid progress in biomedical fields and development of new technologies in bioengineering and tissue engineering, such as 3D bioprinting technologies, lead us to extensive and rapid designing of new biomaterials and medical devices (MDs). The main feature that newly engineered biomaterials must possess, in order to be applied in clinical practice, is to be biocompatible. Besides toxicity testing, genotoxicity and mutagenicity assays are very important in assessment of biocompatibility. Genotoxicity/mutagenicity is a feature that can completely disable the use of some biomaterial and MDs in biomedical and clinical applications especially if material is intended for long term use. Mutagens are agents that can cause heritable changes in DNA and their capacity to cause mutations is defined as mutagenicity. Genotoxicity is a wider term which, besides mutagenicity, refers to the property of an agent to cause various damages to DNA and other disturbances which can affect genes function. In this chapter, we gave an overview of in vitro and in vivo assays that are mostly used in biocompatibility assessment with a focus on the most promising assays for evaluations of genotoxicity and mutagenicity of biomaterials.