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

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

doi:10.3389/fbioe.2020.00258

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.

Highlights

The concept of Safe-by-Design (SbD) was addressed in the field of nanotechnology because of the continuous uncertainty about the potentially harmful effects of nanomaterials on humans and the environment
It is integrated into a Safe Innovation Approach (SIA), which combines the SbD concept and the Regulatory Preparedness (RP) concept. It provides a Trusted Environment (TE), which is a space for enabling a dialogue among stakeholders and regulators for sharing and exchanging knowledge on nanomaterials. It is embedded into and frames the guidelines, which provides the state of scientific knowledge by meta-analysis, specific methods for production of nanocarriers, relevant endpoints to test, and safety aspects to consider it will be shown in the section “GoNanoBioMat SbD Approach,” on physico-chemical properties and their biological effects
SbD approaches should be included in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and relevant OECD guidance and guidelines

Summary

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

Reviewed by: Diana Boraschi, Istituto di Biochimica delle Proteine (IBP), Italy Ivana Fenoglio, University of Turin, Italy Henriqueta Louro, Instituto Nacional de Saúde Doutor Ricardo Jorge, Portugal. Safe-by-Design Approach for the Development of Nanomedicines. 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 GoNanoBioMat project elaborated a methodological SbD approach (GoNanoBioMat SbD approach) for nanomedicines with a focus on polymeric nanobiomaterials (NBMs) used for drug delivery. The nanoscale brings new challenges to product design, manufacturing, and handling. Nanomedicines are costly and require the combination of knowledge from several fields. 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.

INTRODUCTION

DISCUSSION