Research projectPersonalised and generalised integrated biomaterial risk assessment
Standardised assessment of biomaterials paves the way for personalised pre-implantation diagnostics. The EU project PANBioRA makes it possible to predict the patient-specific response to a given biomaterial. This allows the best material to be selected, side effects to be minimised and health aspects to be improved.
Within the project, the partners are developing a modular system using interdisciplinary techniques that will predict the patient-specific response to a given biomaterial as well as offering methods for analysing novel biomaterials. PANBioRA’s testing system will therefore provide an improved, faster, and cheaper assessment of biomaterials. The project will end on 31 December 2021, after four years of fruitful research, collaboration, developments and exciting results.
PANBioRA, “Personalised and generalised integrated biomaterial risk assessment”, is a four-year research and innovation project funded by the European Union’s Horizon 2020 programme. The consortium is formed by 17 partners from 11 EU countries, which are active in biomaterials research, industry, technology transfer and clinical trials; including biomaterial safety, risk assessment, medical devices and implants, as well as multiscale modelling.
The modular approach of PANBioRA brings together the following techniques:
An important focus in the last months has been the final integration of components to the main device and final data collection from sensors. The PANBioRA prototype as designed by partners DOLMEN and DCU will be presented at the project’s closing event on 1 December 2021 in Strasbourg and online.
The final phase in the project furthermore concentrates on the exploitation of the gathered findings, possible patent applications and continuation opportunities for the project after the official ending in December 2021.
Biomaterial Related Advances
- Compact and automated cytokine profiling
- Fast testing of genotoxicity
- Material selection – evidence of risk
- Personalised solutions and treatment options
- Integrated experimental data into the models
- Significant time and cost reduction in biomaterial analysis and medical devices R&D and product development
- Direct application to 3D (bio) manufacturing
- Reduced risk of operator error
- Compact, easy to use
- Comprehensive, modular
- Access to database of previous results
- Risk monitoring during design, development and commercialisation steps
PANBioRA risk rating system – the problem
The development of new and safe biomaterials and related products/devices needs to be complemented with the identification of the potential hazards to human health and environment. With new and innovative materials and methods used in biomaterial development and production, existing guidance is insufficient for biomaterial risk assessment. Furthermore, a risk-based approach involving identification and monitoring of the new and emerging risks posed by such material or production technologies is also not widely available in the market.
The PANBioRA Risk Radar and the Risk Rating tool, are web tools to aid and support stakeholder decisions based on anticipatory and adaptive data in addition to experimental and modelling data used for biological evaluation of biomaterials and related medical products and devices.
- The Risk Radar allows user-specific input of topic and continuously identify, analyse and monitor emerging risks in the field of biomaterials to anticipate the risks and opportunities.
- The Risk Rating tool is using the multi-criteria decision method (MCDM) to aid material selection based on evaluation of multiple criteria with conflicting outcomes. The criteria and their weights can be modified based on an initial PANBioRA criteria set to include Mimotope Variance Analysis (MVA), cytotoxicity, hepatoxicity, barrier integrity, inflammation markers and genotoxicity.
The Risk Radar and Risk Rating tool are being mainly developed by partner Steinbeis Advanced Risk Technologies GmbH (RTECH). The Steinbeis Europa Zentrum is project coordinator and is responsible for administrative project coordination as well as communication, dissemination of project results and IPR management.Zu allen Artikel