Opendata, web and dolomites
  1. home
  2. trasparenza
  3. open h2020
  4. biorima
  5. reports

Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - BIORIMA (BIOmaterial RIsk MAnagement)

Teaser

\"BIORIMA is focusing on biomaterials in the nano range in accordance with the call’s emphasis on \"\"Support for good governance in biomaterials research following the safe, integrated and responsible approach as laid down in \"\"Nanosciences and Nanotechnologies: An action plan...

Summary

\"BIORIMA is focusing on biomaterials in the nano range in accordance with the call’s emphasis on \"\"Support for good governance in biomaterials research following the safe, integrated and responsible approach as laid down in \"\"Nanosciences and Nanotechnologies: An action plan for Europe\"\". However, it is clear from Nanosafety research that the material size is a continuous spectrum and the BIORIMA approach is also applicable to larger-sized biomaterials. Specifically, BIORIMA has the following objectives:
Objective 1: Generate and store a bank of relevant reference and/or certified, well-characterised reference NBM – covering the classes: metal/metal oxide, ceramics, organics and hypbrids (see Table 1) - for use in BIORIMA and for future projects which produce NBM and need to have access to the reference BIORIMA NBM for comparative purpose. Support the standardisation of the production methods (e.g. large sample preparation/assessment) of the proposed NBM, including methods that will reflect their eventual deployment as part of ATMP and MD. Undertake a Life Cycle Analysis of the proposed NBM and perform an assessment of their potential exposure to humans and the environment.
Objective 2: Develop exposure assessment/monitoring systems, on the field detection systems as well as methods for their performance assessment; assess accidental risks including explosion and massive release of NBM.
Objective 3: Compare and validate current (and/or to develop including validation of new) test methods, including in vitro, in vivo methods, to detect adverse effects from NBM to:
• human health including acute and chronic toxicity (including oral, inhalation, dermal and intravenous injection);
• environment; ecotoxicity tests, persistence, bioaccumulation, toxicity and life cycle impacts on all forms of biota;
• integrate the Exposure and Hazard assessment into an overarching Intelligent Testing Strategy (ITS) compatible with the current evaluation/test guidance for biomaterials ISO-10993-1;
Objective 4: Develop (web-based) predictive models of the toxic behaviour of engineered NBM; To adapt, extend and validate a reliable thorough overarching methodology for tiered risk assessment for engineered NBM; generate different risk reduction strategies and systems and the BIORIMA IRM framework for evaluating and implementing them; develop a rationale for selecting the tools in objectives 1, 2 and 3 and use them to evaluate the risk profile of NBM – as demonstrated through case studies; integrate the BIORIMA tools into a web-based Decision Support System (DSS) available to all stakeholders (Academia, Industry, Patient organisation, regulatory bodies and Standardisation authorities).

\"

Work performed

We have successfully produced a Project Data Inventory, identified existing/new requirements regarding data collection incl. deployment of the BIORIMA eNanoMapper database. The selection, production, distribution and characterization of the nanobiomaterials (NBM) are being dealt with. The selection of NBM was devoted to maximize the impact of BIORIMA by selecting a set of NBM that represent real-world needs of industry, regulators and other stakeholders working with biomaterials for biomedical applications. Industrial NBM were produced and these batches include novel materials that have undergone sterilization and milling to facilitate the novel, correct and relevant experiments design. It was demonstrated that there are several activities in the life cycle of NBMs where a potential release of particles in the nanometre range is likely to occur. The human health and Environmental Risk Assessment work and the strategies and methods for monitoring is on track. The work follows on from the large-scale project LifeLongJoints (LLJ), FP7-NMP-2012-LARGE-6, co-ordinated by LEEDS, in which wear particle characteristics and toxicology were not studied. BIORIMA investigates release of materials from these implants. The data generated in BIORIMA, enabled LEEDS to secure three new standards in Isolation and characterisation of wear particles (CWA 17253-1; ISO 17853; ASTM F1877). The overall aim of WP4 is to develop robust, inter-laboratory validated test methods for identification of potential adverse health effects of NBM containing medical products and devices as well as testing schemes to assess possible environmental effects of such materials. The materials span different biomedical applications. We develop a conceptual integrated human health and environmental Risk Assessment (RA) strategy for NBM used in MD and ATMP. This strategy includes tailored Integrated Approaches to Testing and Assessment (IATA) based on experimental and modelling tools for hazard assessment of NBMs. WP 5 further developed a conceptual strategy for Risk Management (RM) of NBM\'s. This is supported, by development of predictive nanoinformatics models, based on statistical and machine learning approaches, with a web-implementation initiated. These developments were coordinated and integrated into the BIORIMA Risk Management Framework (RMF) A first version of this RMF was presented and discussed and reported in “White Paper: Towards a Risk Management Framework for nano-biomaterials used in MD and ATMP”. The development of the BIORIMA DSS has started. Basic communication channels were set, internal and external training has been carried out as planned, and IPR measures have been set-up. The transfer of the pre-normative research results to regulatory bodies has been focused to preliminary contacts with regulatory bodies, as regulatory documents are still in the development phase, as output of work from previous work-packages. 

Final results

A key work during this first period was promoting the NBM selection, production and distribution. This allowed the partner to have the target NBM and to start the experimental activity. The widespread characterization action supported provided new and extensive physicochemical descriptors to be used in WP 3-5 to promote the correlation and get information on real in vitro dose and fate, in complex biological system. Strong participation of the companies to production and distribution of NBM offered a key tool to the project, in terms of availability of NBM at high TRL with a clear regulation pathway and of robust information ready to be exploited. Work on hazard assessment is comprehensive and deals both with human health and environmental impacts. We have addressed both acute and chronic or long-term effects and this is something that we will continue to work on in WP4 in order to develop robust test methods for both acute and chronic effects. Some of the work is already being utilized towards the development of new test standards and this is something will continue to emphasize as we move forward; it is not sufficient to generate data sets across multiple different model systems, but we also need to ensure contributing to the development or validation of robust test methods for nanobiomaterials that are manufactured for medical products or devices. The BIORIMA IRM framework validation strategy reflects the commitment to bring the achieved results to the NBMs value chain, from production and use, to end-of-life treatments in both industrial facilities and hospitals. Our dissemination strategy reflects the commitment to bring the achieved results to the global community in general and to interested stakeholder groups. Public Training Schools open to everyone support this strategy.

Website & more info

More info: http://www.biorima.eu.