Editorial: Polymeric Nano-Biomaterials for Medical Applications: Advancements in Developing and Implementation Considering Safety-by-Design Concepts

Citation: Borchard G, Som C, Zinn M, Ostafe V, Borges O, Perale G and Wick P (2020) Editorial: Polymeric Nano-Biomaterials for Medical Applications: Advancements in Developing and Implementation Considering Safety-by-Design Concepts. Front. Bioeng. Biotechnol. 8:599950. doi: 10.3389/fbioe.2020.599950 Editorial: Polymeric Nano-Biomaterials for Medical Applications: Advancements in Developing and Implementation Considering Safety-by-Design Concepts

The aging population represents an enormous social, structural, and financial burden on society. To address the potential problems of supporting an elderly population, it is important to consider ways of enabling individuals to maintain independence and quality-of-life (QoL) for as long as possible. To achieve this, we need to develop new solutions and novel concepts through technologies, and researchers have been exploring how disease and aging are mediated by molecular processes at the nanoscale. The subsequent nanotechnology-enabled approaches that have emerged in recent years include innovative nano-materials and nano-devices, which could enable interventions at the molecular length scale and are, therefore, an important cornerstone in building solutions.
As for every novel technology or material, a careful safety assessment is needed early in its development to avoid social and economic drawbacks. While guidelines and legislation have been put in place for therapeutics of low molecular weight along with much more complex biologics as well as their follow-on products (generics and biosimilars, respectively), the regulatory approach for advanced therapeutics including polymeric biomaterials is still in its infancy. The rise of so-called "nanomedicines" or complex therapeutics along with follow-on products such as "nanosimilars" or "complex generics" have provided advantageous attributes on the nanoscale, but the lack of guidance is a difficult challenge that needs to be addressed in the development of such products in future.
This issue describes some of the different nano-biomaterials that are currently being studied for the preparation of nanoscale drug carriers. The preparation of nano-vectors using these materials is also complex that needs to be better understood, in particular when self-assembly processes are used to implement therapeutic drug delivery (Yadav et al.). These issues render comparative efficacy studies difficult and preclude the introduction of a "safe-by-design" concept, as developed in the framework of the European project "GoNanoBioMat" (https://gonanobiomat. eu/). As a concept, safe-by-design is currently being adapted for use in research on nano-biomaterials, based on the processes used in drug discovery and development, which adopt safety aspects early in the process (Schmutz et al.). It is intended that this concept in combination with other existing regulatory frameworks, will guide small and medium-sized companies during the development process of nanomedicines, span stages from material selection and design, characterization, assessment of human, and environmental health risks, to manufacturing and control, as well as storage and transport of the final product.
This special issue also focuses on the hazard assessment The diversity of the different papers presented in this special issue are indicative of the significant interplay between life and the material sciences with computational approaches. We believe that this exchange of ideas is one of the best approaches to tackling the increasingly complex challenges of an aging society.

AUTHOR CONTRIBUTIONS
GB has drafted the manuscript and submitted in final form. CS, MZ, VO, OB, GP, and PW have revised the manuscript draft. All authors contributed to the article and approved the submitted version.

Conflict of Interest:
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Copyright © 2020 Borchard, Som, Zinn, Ostafe, Borges, Perale and Wick. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.