WG Safety and Characterization
This WG aims to exploit the full potential of nanotechnologies for diagnostic, therapeutic or regenerative applications their special features need to be integrated with other enabling technologies. Whilst each of the KETs individually already have huge potential for innovation, their cross-fertilisation is particularly important as combinations of KETs offer even greater possibilities to foster innovation & create new markets [ref. to ETPN-SRIA 2016-2030]. Thus, the WG SC domain is to (i) enhance successful translation of nanobio-enabled products through fostering scientific networking and enhancement in the field of advanced physico-chemical, in vitro and in vivo characterization and (ii) address related safety issues from the very early stage of development.
CEA at Bionano Net, Austria
TNA Manager chez EUNCL, CEA, France
Benefits and challenges of this working group
So far nanotechnology has mainly impacted pharmaceutical applications, because it provides a large variety of carrier systems which help to deliver and target drugs with low solubility or high toxicity in an unprecedented way.
As a matter of fact the translation to the market is limited when no evidence of safety can be shown.
The WG Safety & Characterization (WG SC) aims to support in this field with all its enabling techniques, models, methods, either on the safety assessment side, or with advanced physico-chemical, in vitro and in vivo characterization. Thus, the nanomedicine community benefits from the WG SC:
- to find experts to support on safety & characterization issues;
- to make nano-enabled medical applications safer;
- to contribute to long-term successful translation of nano-enabled developments;
A key challenge for this WG is to ensure a proper connection of the nanomedicine community with the nanosafety community, in which a huge portfolio of high quality test systems are already available, and the regulatory bodies.
Past realizations & accomplishments
- To establish the interaction between Nanomedicine Community and EU NanoSafety-Cluster (NSC) as well as the European Pilot Production Network (EPPN);
- To identify cross-disciplinary synergy potential – this WG is an “enabling” WG 3. to contribute and support the work of other WGs; e.g. in the fields of regulation, training, etc. 4. to inform the ETPN-WG Saftey & Characterization members and further interested members about relevant safety & characterization information e.g. roadmaps, task force reports, etc;
- Connect safety & characterization facilities with European hubs e.g. via EUNCL, national communities, etc.;
- Connect with NOBEL;
- Connect with REFINE;
- Connect with EMA and national regulatory bodies;
- Identify further competences in terms of safety, etc. within and outside the ETPN; e.g. European projects; scientific enhancement in the field of advanced physico-chemical, in vitro and in vivo characterization and the relationship between properties/efficacy and toxicity/safety through fostering of scientific networking;
- Connect nanomedicine with nanosafety community in terms of governance, based on NANoREG, moving forward to ongoing and future projects e.g. ref.mat. could be one topic;