PMID- 32300587
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2296-4185 (Print)
IS  - 2296-4185 (Electronic)
IS  - 2296-4185 (Linking)
VI  - 8
DP  - 2020
TI  - A Methodological Safe-by-Design Approach for the Development of Nanomedicines.
PG  - 258
LID - 10.3389/fbioe.2020.00258 [doi]
LID - 258
AB  - 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.
CI  - Copyright (c) 2020 Schmutz, Borges, Jesus, Borchard, Perale, Zinn, Sips, 
      Soeteman-Hernandez, Wick and Som.
FAU - Schmutz, Melanie
AU  - Schmutz M
AD  - Technology and Society Laboratory, Empa - Swiss Federal Laboratories for 
      Materials Science and Technology, St. Gallen, Switzerland.
FAU - Borges, Olga
AU  - Borges O
AD  - Center for Neuroscience and Cell Biology, Faculty of Pharmacy, University of 
      Coimbra, Coimbra, Portugal.
FAU - Jesus, Sandra
AU  - Jesus S
AD  - Center for Neuroscience and Cell Biology, Faculty of Pharmacy, University of 
      Coimbra, Coimbra, Portugal.
FAU - Borchard, Gerrit
AU  - Borchard G
AD  - School of Pharmaceutical Sciences Geneva-Lausanne, Geneva, Switzerland.
FAU - Perale, Giuseppe
AU  - Perale G
AD  - Polymer Engineering Laboratory, Department of Innovative Technologies, Mechanical 
      Engineering and Materials Technology Institute, University of Applied Sciences 
      and Arts of Southern Switzerland, Manno, Switzerland.
FAU - Zinn, Manfred
AU  - Zinn M
AD  - Institute of Life Technologies, University of Applied Sciences and Arts Western 
      Switzerland (HES-SO Valais-Wallis), Sion, Switzerland.
FAU - Sips, Adrienne A J A M
AU  - Sips AAJAM
AD  - National Institute for Public Health and the Environment, Bilthoven, Netherlands.
FAU - Soeteman-Hernandez, Lya G
AU  - Soeteman-Hernandez LG
AD  - National Institute for Public Health and the Environment, Bilthoven, Netherlands.
FAU - Wick, Peter
AU  - Wick P
AD  - Particles-Biology Interactions Lab, Empa - Swiss Federal Laboratories for 
      Materials Science and Technology, St. Gallen, Switzerland.
FAU - Som, Claudia
AU  - Som C
AD  - Technology and Society Laboratory, Empa - Swiss Federal Laboratories for 
      Materials Science and Technology, St. Gallen, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20200402
PL  - Switzerland
TA  - Front Bioeng Biotechnol
JT  - Frontiers in bioengineering and biotechnology
JID - 101632513
PMC - PMC7145422
OTO - NOTNLM
OT  - Safe-by-Design
OT  - drug delivery
OT  - nanocarriers
OT  - nanomedicine
OT  - polymeric nanobiomaterials
EDAT- 2020/04/18 06:00
MHDA- 2020/04/18 06:01
PMCR- 2020/01/01
CRDT- 2020/04/18 06:00
PHST- 2019/10/31 00:00 [received]
PHST- 2020/03/12 00:00 [accepted]
PHST- 2020/04/18 06:00 [entrez]
PHST- 2020/04/18 06:00 [pubmed]
PHST- 2020/04/18 06:01 [medline]
PHST- 2020/01/01 00:00 [pmc-release]
AID - 10.3389/fbioe.2020.00258 [doi]
PST - epublish
SO  - Front Bioeng Biotechnol. 2020 Apr 2;8:258. doi: 10.3389/fbioe.2020.00258. 
      eCollection 2020.