AcumenIST SPRL has a strong track record in materials-science and R&I-management, public and regulatory affairs, harmonisation & standardisation, and policy-assessment/-development, and provides MACRAMÉ with streamlined scientific coordination, administration and targeted dissemination-, communication- and exploitation- management, thus widening the collaborative network of both the AIST concept consultancy and the new NanoFabNet Hub.
Bioanalytik Münster e.V. provides state-of-the-art scientific, technical, regulatory, and political background for the external alignment, finetuning and guidance of the work in all WP, to establish interfaces between communities and regulatory frameworks for the complete life-cycle of AdMa and AdMa-bearing products (WP1). BioMS will thus widen its network and business-support portfolio to include services for the next generation of materials.
The Laboratoire National de Métrologie et d’Essais leads the advanced characterisation approaches of AdMa(@CM)s, based on its expertise in nanoparticles aerosol generation, airborne particles characterisation, and simulation of end-of-life scenarios. As France’s NMI and Notified Body, LNE will use its strong links to standardisation, harmonisation and policy-making & -informing bodies. LNE’ role in MACRAMÉ strengthens its NanoMesureFrance Centre in connecting industry and regulatory bodies.
The Luxembourg Institute of Science and Technology provides advanced in-vitro models and expertise for inhalation toxicology, physical-chemical characterisation of AdMa(@CM)s, regulatory support, and standardisation & harmonisation activities. Based on a fully equipped infrastructure, LIST developed several in-vitro alternative models (with 3 under validation) and will exploit the MACRAMÉ models in projects, and to provide services and support companies through spin-offs and licenses.
Seven Past Nine (based in Germany and Slovenia) designs (meta)data formats, data warehouses, web applications for R&I in life science, toxicology, and chem-, bio- and nano-informatics. The 7P9-Collective will guide MACRAMÉ in community and regulatory reporting standards, through its data shepherd consultancy services, which – in turn – will be widened to include AdMas and novel ontologies for their complex matrices, thus allowing exploitation in future research and commercial projects.
Seven Past Nine (based in Germany and Slovenia) designs (meta)data formats, data warehouses, web applications for R&I in life science, toxicology, and chem-, bio- and nano-informatics. The 7P9-Collective will guide MACRAMÉ in community and regulatory reporting standards, through its data shepherd consultancy services, which – in turn – will be widened to include AdMas and novel ontologies for their complex matrices, thus allowing exploitation in future research and commercial projects.
The German Federal Institute for occupational Safety and Health coordinates MACRAMÉ’s harmonisation of characterisation and test methods, as the secretariat of the Malta-Initiative, and drives the Project’s study of the fibre-paradigm and corresponding aerosol generation method. Through close contact with scientific and industry partners throughout Europe and international regulatory bodies (incl. US, South Africa and Korea), BAuA disseminates the Project to international decision-makers.
The Dutch National Institute for Public Health and the Environment contributes to benchmarking and demonstration of cell-line-based in-vitro assays for initial screening of inhalable materials. RIVM will broaden its activities and expertise in transregulatory activities on nanosafety, nanomedicine (i.e. Gov4Nano, REFINE) to include AdMa(@CM)s, thus strengthening its lead of the OECD WPMN.
The IBE R&D Institute for Lung Health gGmbH conducts and intends to validate the AMA, prepares biological samples for quantitative imaging with LA-ICP-MS, conducts DFM/HSI/Raman bioimaging, and pre-evaluate biological samples for ToF-SIMS analyses, and develops innovative and cost-effective testing strategies for aerosolised fibres deposited in µ-dishes. The latter technique will be exploited through appropriate IPR. IBE owns all necessary equipment.
TASCON develops and performs ToF-SIMS on raw materials, develops and performs ToF-SIMS imaging on biological samples pre-characterised by IBE. It owns three ToF-SIMS 5 and uses one Hybrid-SIMS instrument. Knowledge gained in the project will improve TASCON’s services to academic and industrial partners. Exploitation of results will be performed by peer-reviewed publications and contributions to scientific conferences.
The Fundacion GAIKER leads the development of novel ecotox tests at relevant Exposure Points for the Use-Cases. Owning all necessary infrastructure, GAIKER’s aims to transfer technologies and offer technological services to its Foundation members and industrial clients. The assays and methods developed and ready for standardisation will be incorporated the service portfolio, thus helping industries to reduce costs, and time to market in regulatory compliance.
MyBiotech GmbH provides ciprofloxacin loaded PLGA NPs and know-how for inhalation therapy, produced by following ICH guidelines under GMP like conditions (Use-Case 5), physical-chemical characterisation of those particles and preparation of surrogate (controle) particles. A successful biotech-SME with international presence, MyB plans to use the Project results to transfer its ciprofloxacin-loaded PLGA NPs to GMP-environments for human trials.
BASF SE conducts the AMA and validates the assay in a round robin together with IBE and LIST, while its analytical department performs quantitative imaging with LA-ICP-MS of the exposed samples to establish dosimetry in the macrophage assay. BASF is highly interested in establishing and validate in-vitro methods, to support its own material-development work, as well as the practices and standards at its suppliers and customers.
MEDICA SPA provides market-relevant AdMas and AdMa@CMs for water filters to soon be applied to end-user markets (e.g. building developers) (Use-Case 1), by grating Partners access to the production area for sampling of process- and waste-water, in accordance with hydraulic and recirculation plants’ designs. MEDICA exploits the results to ‘close-the-circle’ of the product’s sustainability, in line with its Medica Water Division business plan.
Carbon Waters provides Use-Case 2 (i.e. FLG in BMS) through the production of FLG dispersions and samples of epoxy resin (with FLG), following in-house quality-control through Raman, UV Visible as well as rheological measurements of the formulations; The Project results on the (eco)tox and LCAs will be exploited in proprietary Graph’Up-enhanced epoxy resins for thermal management systems and presented at carbon-based materials conferences.
The FILK Freiberg Institute provides Use-Case 4 (i.e. CNTs in thermoplastic polymeric systems for heating applications), by providing samples at every stage of the life-cycle of the AdMa(@CM)s, created through a roll-milling process to manufacturing of conductive polymer composite films. FILK will pass the resulting safety- and LCA-information to its customers, and publish them in peer-reviewed journals, and its annual report, and present them at international conferences.
TEMAS Solutions specialises in LCA, toxicology and human and environmental risk assessment. Having developed a Safe-by-Design and leading the corresponding standard under CEN/TC 352, and the SafeGraph Project. Through its strong links to various industries, TEMASOL leads the Use-Cases and aims to exploit the Project results in consultancy services regarding SSbD and regulatory affairs to industry in the chemical, cosmetic and medical device sector.
The Swiss Federal Laboratories for Materials Science and Technology provides advanced in-vitro models and expertise for inhalation toxicology, hazard assessment, RA and SSbD, and standardisation and harmonisation, integrating state-of-the-art infrastructures and platforms to assess abrasion and thermal decomposition, and parallel ‘emission/acute lung’-cytotoxicity. Through long experience in the exploitation of models and tools (NanoBioMat, LICARA), EMPA will support SMEs with the MACRAMÉ results.
Epithelix SARL provides standardised and commercially globally available in-vitro models based on primary human cells and performs in-vitro evaluation of impact airborne substances on human respiratory tract models. The SME aims to achieve validation as part of a tiered approach, offering efficiency and cost-reduction to the industries.
The University of Birmingham provides data shepherding to all partners, including dataset curation, annotation and compilation for modelling / ML (NanoCommons), and conducts ecotox testing on the Use-Case AdMa@CMs, based on fully equipped labs for cytotoxicity and materials characterisation. As coordinator of the NanoSafetyCluster, and partner in PARC, UoB will disseminate the results to both the academic and regulatory (nano)materials- and chemical safety communities.
