A Methodological Safe-by-Design Approach for the Development of Nanomedicines

Mélanie Schmutz; Olga Borges; Sandra Jesus; Gerrit Borchard; Giuseppe Perale; Manfred Zinn; Ädrienne A J A M Sips; Lya G Soeteman-Hernandez; Peter Wick; Claudia Som

doi:10.3389/fbioe.2020.00258

A Methodological Safe-by-Design Approach for the Development of Nanomedicines

Front Bioeng Biotechnol. 2020 Apr 2:8:258. doi: 10.3389/fbioe.2020.00258. eCollection 2020.

Authors

Affiliations

¹ Technology and Society Laboratory, Empa - Swiss Federal Laboratories for Materials Science and Technology, St. Gallen, Switzerland.
² Center for Neuroscience and Cell Biology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.
³ School of Pharmaceutical Sciences Geneva-Lausanne, Geneva, Switzerland.
⁴ Polymer Engineering Laboratory, Department of Innovative Technologies, Mechanical Engineering and Materials Technology Institute, University of Applied Sciences and Arts of Southern Switzerland, Manno, Switzerland.
⁵ Institute of Life Technologies, University of Applied Sciences and Arts Western Switzerland (HES-SO Valais-Wallis), Sion, Switzerland.
⁶ National Institute for Public Health and the Environment, Bilthoven, Netherlands.
⁷ Particles-Biology Interactions Lab, Empa - Swiss Federal Laboratories for Materials Science and Technology, St. Gallen, Switzerland.

Abstract

Safe-by-Design (SbD) concepts foresee the risk identification and reduction as well as uncertainties regarding human health and environmental safety in early stages of product development. The EU's NANoREG project and further on the H2020 ProSafe initiative, NanoReg2, and CALIBRATE projects have developed a general SbD approach for nanotechnologies (e.g., paints, textiles, etc.). Based on it, the GoNanoBioMat project elaborated a methodological SbD approach (GoNanoBioMat SbD approach) for nanomedicines with a focus on polymeric nanobiomaterials (NBMs) used for drug delivery. NBMs have various advantages such as the potential to increase drug efficacy and bioavailability. However, the nanoscale brings new challenges to product design, manufacturing, and handling. Nanomedicines are costly and require the combination of knowledge from several fields. In this paper, we present the GoNanoBioMat SbD approach, which allows identifying and addressing the relevant safety aspects to address when developing polymeric NBMs during design, characterization, assessment of human health and environmental risk, manufacturing and handling, and combines the nanoscale and medicine field under one approach. Furthermore, regulatory requirements are integrated into the innovation process.

Keywords: Safe-by-Design; drug delivery; nanocarriers; nanomedicine; polymeric nanobiomaterials.