Behaviors and Persistence of Nanomaterials in Biomedical Applications

Chapter 7Conclusions and Perspectives

Nanomaterials have demonstrated the potential to revolutionize the way in which neoplasms are diagnosed and treated. Some efficient treatments relying on organic nanomaterials are already in the market while the even more promising ones based on noble metals are still on the bench scale. In particular, the intrinsic features of nanomaterials offer the possibility of the development of synergistic non-invasive treatments, by designing unique theranostic agents.

Despite the giant number of proposed nanoplatforms for development of healthcare products in the last decade, almost all have led to failure before the clinical stage. This is related to lack of sufficient knowledge of the regulatory and industrial requirements by researchers and the lack of available standard regulatory frameworks [1]. The pipeline for the development of a nanomaterial for healthcare is composed by its in silico/in vitro investigations, pre-clinical and manufacturing validation, and to clinical pilot and phase II/III validations. It is worth to notice that only the most promising nanomaterials can pass to the costly pre-clinical and following assessments. For a better understanding on the validation steps, we would like to suggest to readers the story of the first approved nanomaterial for healthcare application, Doxil [2].

Chiefly, a nanomaterial has to work efficiently and safely to attract industrial interests. It has to meet good manufacturing practice (GMP) standards, ...