BIORIMA’s Final Public Event – Results, Reflections and Aspirations

A large audience of wide-ranging stakeholders logged on to take part in BIORIMA’s final public event, held on January 19th, 2022. Organised with polished efficiency by Lisa Bregoli and Stefania Melandri, Warrant Hub, the event comprised three distinct and engaging sessions: 1. Presentation of BIORIMA Final Results 2. Nanosafety projects response to real-world needs 3. NSC-community-activity “Brainstorming of future collaboration for nanobiomaterials risk assessment”

Video link:


Presentation of BIORIMA Final Results
With a full morning dedicated to focusing on technical outcomes of the project and its case studies, Lang Tran (IOM), the BIORIMA Project Coordinator, launched the event to welcome everyone and introduce the proceedings.

The first presenter, Magda Blosi (CNR-ISTEC), then took to the virtual platform to present highlights of BIORIMA's final results and achievements of WP2's materials studies. Magda mentioned that from this WP, representative and extensively characterised nanobiomaterials (NBMs) have been provided; it has supported the standardisation of NBM production methods; it has advanced and improved the current testing procedures on the new class of NBMs; provided wide-ranging characterisation in support of risk assessment; build SbD alternatives on NBMs, and promoted the development of new eco(tox) key-descriptors for the considered NBMs.

In the next presentation, the outcomes from the WP3 exposure studies were delivered by Bernd Nowack (EMPA), in which he highlighted that this WP has identified release and exposure scenarios for NBMs; performed the characterization of NBM release from materials; developed methods for evaluating NBM release from implants, modelled the environmental release and exposure of NBMs; and finally developed and applied exposure and biomonitoring systems in real situations, among other achievements.

Bengt Fadeel (Karolinska Institutet) and Janeck Scott-Fordsmand (Aarhus University) followed in a presentation of the WP4 outcomes from hazard studies. This WP sought to develop reliable and robust test methods for identification of potential adverse health effects of nanobiomaterial (NBM) enabled medical devices (MDs) and advanced therapy medicinal products (ATMPs) and to evaluate schemes to assess the potential environmental effects of NBMs.

It was concluded that WP4 has generated a wealth of data in relation to the hazard assessment of these materials using a arrange of in vitro and in vivo model systems relevant for human health that the environment. The Standard Operating Procedures (SOPs) and collected data are available for other users. Based on this work, modifications to existing test guidelines are suggested, and selected tests may be developed into standards, pending further validation through ISO/CEN (see image)

Meanwhile, Janeck Scott-Fordsmand emphasised how the test systems have been evaluated in terms of compliance with OECD test guidelines as well as focusing on sustainability

A short coffee break was taken, before the meeting resumed with WP5 speakers - Danail Hristozov, Alex Zabeo, and Virginia Cazzagon (Greendecision Srl) – who gave the audience a valuable insight into the workings of the BIORIMA Decision Support System (DSS) for risk assessment and management of NBMs. The DSS aims at supporting stakeholders in the assessment and management of occupational and environmental risks of NBMs used in medical applications. The DSS is the software implementation of the BIORIMA Risk Management Framework.

Alex Zabeo followed up with a hands-on demonstration of the system itself, taking the audience through use-case scenarios in a journey that displayed the user-friendliness of the system and its attractive interface.

Virginia Cazzegon complemented this by taking the audience through an occupational risk assessment of magnetite NPs used as contrast agent in MRI applications using the BIORIMA DSS.

The presentations of the project's final results concluded with WP6 outcomes from case studies, presented by Carlos Fito (ITENE). His overview included a report on the local validation and remote validation case studies involving Key Performance Indicators (KPIs), direct consultation using tailored surveys, and webinars with voting. Carlos went on to describe how all the different tools and methodologies developed in the BIORIMA project have been captured, transferred, and made available in factsheets produced by Rudolf Reuther (ENAS) that show their applicability, technology readiness levels, compliance with standards where relevant, and related sources. Among the lessons learned from industry, Carlos highlighted the barriers that need to be surmounted within industry and how the BIORIMA project outcomes can help achieve this.

The floor was then given to Marcello Cacace to comment on his impressions of the project and the partners' work over the past four years. Among his observations, Marcello stated:
"I was impressed by the fact that each work package performed in my opinion very well. The picture that one can gather is overarching and covered the principal issues of nm risk. It should be emphasised that the results are there and are available to the scientific community. This is important. It is very important that the results and the framework you provide are brought to the attention of stakeholders and government. A sincere congratulations to all of you."

Nanosafety projects response to real-world needs

When BIORIMA kicked-off over four years ago, no-one predicted that the world would succumb to a pandemic in the way that it has. Despite lockdown constraints, the BIORIMA project responded quickly and addressed key issues by forming an expert Task Force, whose work was the focus of the next session: COVID-19 Task Force of BIORIMA: Addressing the Needs of the Pandemic, chaired by Bengt Fadeel (Karolinska Institutet) and Lang Tran (Institute of Occupational Medicine).

Following an introduction to the topic, Bengt's presentation, 'From nanosafety research to vaccines', demonstrated how nanomaterials have an important part to play in PPE, facemasks and so forth, surface coatings, and of course in mRNA vaccines. Emphasising that vaccines are indeed the way forward, Bengt proceeded to deliver a highly informative talk that summarised all the vaccines that are currently being applied.

Next, in her presentation "Silver nanoparticles as a potential anti-viral agent", Anna Costa (CNR- ISTEC) described how the COVID-19 Task Force emerged from the needs of the pandemic and outlined its endeavours to reduce exposure and hazard. Anna looked at what is required of anti-viral technologies, including low-cost and green ingredients, ease of scalability, ease of applicability, high stability, and circularity, as well as considering significant safety aspects. During lockdown, ISTEC worked on these requirements as part of a joint effort with the ongoing SbyD initiative, ASINA, and showed how this research may continue.

In discussing 'Pegylated lipid nanoparticles: making vaccines safe', Terry Wilkins (University of Leeds)
commenced with an overview of his role in the COVID-19 Task Force, including reducing hazards and risks of pseudo anaphylaxis for mRNA vaccines encapsulated in PEGylated liposomes; examining if this knowledge can be usefully applied to BIORIMA's research in PEG; PEG-PLGA and solid-lipid nanoparticles in nanmedicine; and guiding future development in these areas. An in-depth review was conducted in collaboration with Marco Monopoli (RCSI Royal College of Surgeons, Ireland) from which it emerged that there is a need for discussions with Clinical Immunologists to assess if further work is required, and that BIORIMA's SbyD methods could be used to design better vaccine nanocapsules.

Continuing the theme, and standing on the shoulders of Charles Darwin, Janeck Scott-Fordsmand (Aarhus University), in his presentation on 'Environmental perspectives on COVID-19', concluded that invertebrates have mechanisms to handle viruses; they have Angiotensin-Converting Enzyme (ACE) activation mechanisms; and certain NBMs cause the activation of ACE. Studies on invertebrates, such as the earthworm study that Janeck highlighted, continue to inform us about human biological responses.

During the Round Table discussions that followed, Marco Monopoli (RCSI) mentioned his closely related work in the NanoCarb project, while Miguel Banares (CSIC) discussed his work on minimising exposure using thermal catalytic filters and ongoing work at the Hong Kong University of Science and Technology on photocatalytic filters.

The Round Table stimulated a significant degree of discussion that sadly had to be curtailed due to time constraints. Lang concluded by thanking everybody in the audience for their participation and, particularly for their efforts in the fight against COVID.

NSC-community-activity "Brainstorming of future collaboration for nanobiomaterials risk assessment"

In the final session of the event, NSC-community-activity "Brainstorming of future collaboration for nanobiomaterials risk assessment", the NanoSafety Cluster took the lead under the aegis of BNN (BioNanoNet Forschungsgesellschaft mbH) representatives Andreas Falk and Susanne Resch, who tag-teamed in an important session that, as Lang explained, was designed to inform future EC calls through the voice of the NSC.

In this salient activity, using Mural software, participants took part in a brainstorm to find out what expertise there is available in the immediate community and what participants can 'bring to the table' to address nanosafety issues as well as ongoing and future challenges, including the current pandemic.

Andreas presented the following points to be addressed, urging the audience to envision what they may be working on in time to come:
• Who is who
• Collaboration offer – what is my expertise?
• Collaboration topics – research needs and future trends
• Public communication on the safety of NBMs: Challenges and potential EU NSC activity.

Susanne then guided the 60 participants through the workings of 'MURAL', facilitating what turned out to be a lively session of dynamic activity. As participants responded to these questions in a flurry of 'post-it' notices on the MURAL virtual whiteboard, Lang emphasised that this was one way in which the BIORIMA partners and stakeholders can constructively come together on the NSC platform and have their voices heard. Addressing a final spontaneous question, audience members expressed their keen interest in contributing to an EU NanoSafety Cluster activity on public communication.

Gary Hutchison (Edinburgh Napier University) then spoke in support of this by mentioning a forthcoming publication based on a Delphi style review by DEFRA's hazardous substances advisory committee in relation to the Green Deal, designed to show what kind of challenges toxicologists and the public will have to face. He stressed that this was a successful precedent of the collaborative public communication activity that had just been proposed.

In the final wrap up, Lang Tran (Institute of Occupational Medicine) stated that the 4.5 years of the BIORIMA project had been a lovely time working together, adding: "Although we couldn't meet in person, we'll just have to work harder to make it happen". He expressed his thanks to everyone and especially to Marcelo Cacace, and his absolute pride in what everyone had achieved.