Toxicity, Regulatory Considerations, and Commercialization Aspects of Multi-component Hydrogels

Abstract

Multicomponent hydrogels are an important class of materials that have unique properties which are exploited for target-specific applications in medicine. Although a few systems are currently in preclinical trials and clinical applications, the translation into commercial products is still in its infancy. This is due to the lack of partnership between academia and industry which is very important for scale-up and commercialization. This chapter briefly summarizes the toxicity issues of multicomponent hydrogels related to human health and the environment, which need to be addressed before discussing the regulatory aspects for clinical translation, commercialization and environmental mitigation. The types of approvals required and the factors affecting the scale-up and manufacturing processes are presented in this chapter.