14 - Safety, regulatory issues, long-term biotoxicity, and the processing environment

Abstract

The milestone reached and development achieved in biotechnology within the past decades, has paved the way for various preclinical and clinical investigations. As a matter of fact, biomaterial and biomedical engineering applications have evolved to such a level that it is easier to conduct lifelike and virtual simulations as well as analysis perfectly. Therefore, in the circle of in vitro evaluation of material, there has been a shift to in vivo evaluation. Furthermore, the clinical and preclinical study conducted by surgeons on nanomaterials demonstrates that a huge gap exists between the project and design articles, and the authentic implantation of this biomaterial within the human anatomy. Nanoparticles (NPs) have a tremendous impact in several fields such as electronics, biomaterials, mechanics, biomedical devices, aerospace equipment, and so on. Since the type of implants doesn’t require surgical removal from the human body when it is no longer required, its value is only seen when considering short-term applications, where the device is needed temporarily in the human body. But there is a likely factor to consider in the use of this degradable implants and that is the toxicity of the implants degradation. Therefore, the design of this degradation products or implants must be carefully done in order to test for potential toxicity in the human body. This chapter will discuss the interactions and reactions of the particles of biomaterial within cells biology in vitro and in vivo circle. Furthermore, the evidence of human cell cytotoxicity in relation to the discussed biomaterials will be discussed. Moreover, this chapter will also highlight various definitions as regard to the process of NPs safety. There is, therefore, an urgent need for a reputable standard in this field as well as a consensus for measuring accurately the nanotoxicity level. However, based on the research undertaken by us and countless others, specific types of functionalization can greatly limit the amount of toxicity level leaked into the body; and so far, there has been promising progress as to its clinical application in the future.