WG Safety and Characterization

The assessment of safety and of physico-chemical properties of nanoparticle enabled medicinal products (NEMPs) is a key priority to enable the successful translation of NEMPs into the market. In recent years, significant progresses have been made in the field, e.g. by the creation of a European Nanomedicine Characterisation Laboratory EUNCL (www.euncl.eu), which provides an integrated pre-clinical characterization service and mentoring to the nanomedicine community. Moreover effort have been focalized on the development and standardization of new assays to fill the regulatory gaps (http://refine-nanomed.com/), by exploring new safety-by-design approaches, by initiating the bridging of different communities, with the aim to share common knowledge and coordinate future efforts. However, the community has still to face multiple challenges in the next years. We need (1) to develop a better understanding of the critical quality attributes associated to different classes of NEMPs, (2) develop reference materials with (certified) reference values for one or more critical quality attributes, (3) develop reliable assays to answers regulatory gaps, including the evaluation of the interaction of nanomaterials with the immune system, the assessment of physical and chemical stability of NEMPs in complex biological media, the detection of NEMPs in biological tissues, (4) develop quality and safety-by design approaches to tailor a smart testing strategy adapted to different classes of NEMPs in different application areas such as drug development (ICH Q8-Q11) or medical device design (EU 2017/745), (5) better promote and facilitate early interaction between stakeholders and regulators.

The safety and characterization working group aims to support the stakeholders and the nanomedicine community by:

• providing advice on safety & characterization issues and answering specific questions on safety & characterization issues;
• connecting the community to the EU NanoSafetyCluster and ongoing projects focused on S&C in nanomedicine;
• promoting personal interactions between the members of the WG;
• promoting the discussion within the members on key topics between experts in the field;

Past realizations & accomplishments

• Contributions to the ETPN-SRIA 2014
• Proposed topics for EC Working programs in H2020
• Contributions to the European Commission Task forces on “characterization” and “safety” – both presented at high level group of EC
• Contributed to “closer-to-the-market”-Roadmap (2016), “research regulatory roadmap” (2017) and “Nanobioinformatics”-Roadmap (2018) of EU NanoSafetyCluster
• Contribution to the EU-Asia Dialogue on NanoSafety (creation of a sub-group on “nanosafety and nanomedicine characterization”) 2017, 2018 and 2019;
• Contribution to SCENIHR Guidance on the determination of potential health effects of nanomaterials used in medical devices
• EU-US-alliance and partnership on characterization
• Establishment of interaction link with European Pilot Production Network (EPPN)
• Develop an Excel-List – overview of ETPN-members expertise on safety & characterization
• Establishment of link between governance and regulatory relevant projects e.g. REFINE, Gov4Nano, BIORIMA, RiskGone, NanoRigo, EUNCL, etc.

Key actions:

• Connects the members of the group with progresses and key achievements of ongoing projects (e.g. EUNCL, REFINE, TBMED, Safe&Med Tech, B-Smart, Expert, METASTARG, Nocanther, NOBEL,..) as well as through the interaction with the EU NanoSafetyCluster by providing an online newsletter;
• Create and share yellow pages of the members of the group and a map of the available characterization facilities;
• Collect and share educational material on safety and characterization (webinars, publications, protocols);
• Provide support for discussion of key topics between the members (online forum);
• Connect nanomedicine with other communities, e.g. including the nanosafety community and other KETs platforms to share knowledge and interacting to build up future projects;

Related initiatives, networks & projects:

• EU-US workshop on  “Charac. methods & standards for nanoparticles in medical products”: learn more
• Contact point Nano – Switzerland (contactpointnano.ch): learn more
• NanoCommons: learn more
• The NanoSafety cluster : learn more