Better risk management of engineered biomaterials

PANBioRA's Motivation

Biomaterial-based solutions find various applications in the healthcare system, e.g. in advanced therapy medicinal products or medical devices. However, the currently available methodologies are not sufficient for a proper risk assessment of all biomaterial applications. A new generalized testing system is necessary in order to standadise the evaluation of biomaterials.

The PANBioRA consortium will provide a more intelligent way of selecting the most suitable biomaterial for potential implants. Thus, possible post-implantation complications will be mitigated and reduced.

Solution for a cost-and time-effective risk assessment of biomaterials

PANBioRA's Objectives

The main objective of PANBioRA is to develop a method that allows the cost- and time effective assessment of

  • a new biomaterial under healthy or disease state conditions (generalised testing) or
  • a given biomaterial for a specific patient (personalised testing)

To achieve this goal, the PANBioRA consortium aims to develop a modular system using cross-disciplinary

techniques that will predict the patient-specific response to a given biomaterial. The testing system will integrate different technologies (refined, miniaturised versions of existing methods and new evaluation technologies) into a single instrument that will be able to perform multiple analyses on cell and micro-tissue levels.

With its multidisciplinary protocols and procedures, the PANBioRA testing system will set a new standard for the evaluation of biomaterials.

Multidisciplinary testing system

PANBioRA's Approach

The rating system developed within the PANBioRA project allows biomaterial risk assessment at nano-, micro- and miliscale ranges.

A microfluidic system integration combining several real-time monitoring means (electrochemical sensors, antibody-based cytokine detection, mini-microscopes) and data-fitting will provide more and continuous information using less biomaterial and smaller biological samples.

The developed methods and tools can be used either separately or as part of the integrated model. Following the development and technical validation of the system pre-clinical tests relevant to biomaterial-related risks will be performed in order to prove the systems’ efficacy.

The MVA (Mimotope Variation Analysis) based antibody testing detects the recognition of a specific biomaterial by the immune system in a personalised manner. This will allow to determine patient-specific antibody response profiles for new or existing biomaterials.

In order to analyse biological information at microscale level, PANBioRA includes cytotoxicity and genotoxicity tests with microscopic real-time monitoring capacities. Moreover, PANBioRA integrates biomaterial and cell testing methods.

It uses real-time electrochemical sensing to quantify the cellular response to a given biomaterial. Additionally, it integrates a testing milieu for the extensive biomechanical characterisation of new materials in application microenvironment conditions.

An integrated organ-on-a-chip module will monitor effects of the biomaterial at single organ and systematic levels and detect the risk of possible material-induced disturbance on tissues.

Beyond the different testing modules, the PANBioRA system includes computer simulations and multiscale modelling. Simulations and models will not only support the experimental system and contribute to its generalization but they will also contribute to the evaluation of risks that are difficult to be assessed experimentally.

Web-based modelling tools together with a web-based risk radar will perform the data analysis of the outputs from all modules and simulations.

In a final step, the risk assessment is reinforced by the PANBioRA risk radar, which includes experimental parameters generated by the different modules as well as external risk factors to monitor arising risks. This allows to individually and reliably decide on the implementation of a specific biomaterial.

Components of the PANBioRa biomaterial risk assessment system

Patient-specific interactions between biomaterials and the immune system will be assessed using the ground-breaking Mimotope Variation Analysis technology.
Biochemical responses of cells to the presence of biomaterials will be monitored in real time and by integrated biosensors. In addition, PANBioRA includes cytotoxicity and genotoxicity tests with microscopic real-time monitoring capacities
Real-time electrochemical sensing will be used to determine the cellular response to a given biomaterial. A set of cytokines released to the extracellular environment will be used as biomarkers to assess the cell response to different biomaterials.
Respiratory epithelium, gut and liver tissues will be miniaturized into organoids on chip to allow the determination of possible systemic and target organ-specific effects in both healthy and disease conditions.
Potential risks that are difficult to assess experimentally – such as explosion hazards or full-scale biomaterial/microbiota interactions - will be covered by simulations developed within the project.
Data Analysis
The readouts of the modules will be fed into a model developed within PANBioRA using known biocompatible and hazardous materials to provide a quantitative risk assessment.
PANBioRA will develop a risk rating system that will display the suitability of the tested biomaterial.

Towards better clinical outcomes and savings in healthcare costs PANBioRA’s Impact

PANBioRA will provide a set of tools, composed of protocols and instruments standardising the evaluation of new biomaterials for aspects such as cyto- and genotoxicity. In addition, the project will generate a validated, general methodology to characterise biomaterials.

PANBioRA's testing method will decrease the required time for risk assessment and minimise risks related to the use of both established and new biomaterials.

Its wide application will decrease the rate of complications and ensure better clinical outcomes, leading to massive savings in healthcare costs.

Moreover, PANBioRA will allow a wider population range to gain access to implant procedures and improve their welfare.