NANOTOXICOLOGY PROJECTS
Misvik participates actively in the European nanosafety work and is part of the EU NanoSafety Cluster. www.nanosafetycluster.eu
ONGOING PROJECTS
PrecisionTox
• Grant agreement ID: 965406 (Feb 2021 – Jan 2026)
The goal of PrecisionTox is to improve chemical safety assessment to better protect human health and the environment by using non-traditional test species, multiple fields of knowledge, and powerful computational approaches to understand which chemicals are toxic and why.
- Stakeholder Integration, embedding the Stakeholder Advisory Group in project planning, decision-making, and dissemination ;
- Comparative Toxicology, using high-throughput testing methods across an Evolutionarily Diverse Model Suite of five biomedical model organisms and human cell lines to observe toxic response;
- Molecular Data Production, applying metabolomics and transcriptomics to comparative toxicology samples to trace adverse outcomes via the molecular key events preceding them ;
- Variation in Susceptibility, applying quantitative genetics and gene expression profiling to understand variation in individual susceptibility and develop empirical exposure thresholds ;
- Biomarker Discovery, PrecisionTox Data Commons, and NAM Toolbox, using machine learning to identify biomarkers for molecular key events and creating the dissemination and translation products for their use ; and
- Regulatory Analysis and Application, partnering with risk managers and regulatory agencies to identify opportunities for applying Precision Toxicology within existing regulatory structures and develop draft guidance for industry use and reporting
HARMLESS
• Grant agreement ID: 953183 (Jan 2021 – Jan 2025)
Advanced high aspect ratio and multicomponent materials: towards comprehensive intelligent testing and Safe-by-Design strategies.
Objectives
Seven interconnected objectives define the goals of the HARMLESS project:
- Mode of Action (MoA) based Integrated Approaches to Testing and Assessment (IATAs) for advanced materials by combining conventional and New Approach Methodologies.
- IATAs anchored by comprehensive data analysis on Adverse Outcome Pathways and nanomaterial grouping from animal models.
- Data analysis and data integration supported by big data management solutions.
- Safe Innovation Approach (SIA) development.
- Safe-by-Design (SbD) tool development and validation.
- Verifying the robustness of tools under real-world conditions assessed in different case studies.
- Engagement with stakeholders and collaboration with national and international initiatives.
SABYDOMA
• Grant agreement ID: 862296 (Apr 2020 – Mar 2024)
SABYDOMA’s main objective is to develop a new methodology to address the Safety by Design (SbD) challenge as a Control System Problem. Its technological solution is coupling screening to design, i.e. the screening at the point of production feeds back to modify the design of nanomaterials. SABYDOMA will use system control and optimisation theory including the Model Predictive Control (MPC) philosophy, binding SbD from laboratory innovation to the industrial production line and from decision making processes to project governance.
Objectives
1. To redesign the production process by developing in silico modeling system, based on experimental screening data.
2. To design HT technologies which progress from TRL4 to TRL6 and apply safety by design (SbD) principles in the production process of novel materials.
3. To facilitate short- and long-term studies on nanomaterials using developed technology.
4. To develop SbD technologies in four specific industrial case studies.
5. To create an online high throughput (HT) mode, to redesign production lines and thus speed up the production process, decrease waste production, lower used volumes, and costs.
6. To ensure that SbD procedures are fulfilled by maintaining continuous communication between management and regulators.
Misvik Biology role: To generate HTS data for in silico modelling purposes.
COMPLETED PROJECTS
NanoSolveIT
• Grant agreement ID: 814572 (Jan 2019 – Aug 2023)
Innovative Nanoinformatics models and tools: towards a Solid, verified and Integrated Approach to Predictive (eco)Toxicology (NanoSolveIT).
NanoSolveIT will develop a validated tiered IATA to identify the critical characteristics of nanomaterials responsible for their adverse effects on human health and the environment or for their functionalities in high-tech applications, and will implement a nanoinformatics-driven decision-support strategy based on innovative in silico methods, models and tools. An important novel concept is the nanomaterial fingerprint – a set of descriptors and properties that can be predictively linked to nanomaterials properties, functionality and hazard by the development and integration of advanced nanoinformatics methods and tools.
Objectives
- Nanoinformatics models, recognised for their predictive power and reliability, are widely utilised by stakeholders
- Nanoinformatics models and the IATA are available in an accessible and user-friendly platform
- Data are delivered into the IATA in model friendly formats to maximise applicability and predictivity of models
- Community/stakeholder acceptance of models and IATA is high based on SOPs, benchmarking and case studies
- Industry and regulatory acceptance of the one-stop complete IATA system leads to a direct reduction in animal testing, and the cost and time needed for risk assessment of NMs.
PATROLS
• Grant agreement ID: 760813 (Jan 2018 – Sep 2021)
(Physiologically Anchored Tools for Realistic nanOmateriaL hazard aSsessment)
Project summary
The main goal of the PATROLS project is to provide an innovative and effective set of laboratory and computational techniques to improve prediction potential human and environmental hazards, because of exposure from engineered nanomaterials (ENMs).
Objectives
1. To develop realistic and predictive lung, gastrointestinal tract, and liver models for ENMs safety assessment, leading to reduction of animal laboratory use
2. Employing novel approaches to evaluate safety within ecologically significant test systems and organisms, chosen based on their role in the food chain.
3. Developing solid computational techniques to model exposure and dosage of ENMs, while predicting potential hazard.
4. Describing ENMs in specific experimental conditions guided by the advancement of human and environmental models.
CALIBRATE
Grant agreement ID: 686239 (May 2016 – Oct 2019)
Objectives
“The key objective of the caLIBRAte project is to funnel the state-of-the-art in nanosafety research and merge it with state-of-the-art risk governance and communication sciences to establish a versatile risk governance framework for assessment and management of human and environmental risks of ENM and ENM-enabled products. The ultimate goal is that the quality and trust in the nano-specific models in the caLIBRAte risk governance framework will exceed current level of most existing REACH tools.”
The role of Misvik Biology in calibrate was to perform high throughput and high content screening to fill the data gaps existing in the nanomaterial toxicity data.
Prof. Grafström giving a talk at the caLIBRAte kickoff meeting in Denmark
NANOSOLUTIONS
Grant agreement ID: 309329 (Apr 2013 – Mar 2017)
Objectives
“The overarching aim of the NANOSOLUTIONS consortium is to provide a means to develop a safety classification for engineered nanomaterials (ENM) based on an understanding of their interactions with living organisms at molecular, cellular and organism levels. The objective is to determine the “biological identity” of ENM, and subsequently develop a computer program that can predict from the properties of ENM their ability to cause health or environmental hazards. New innovative methods are needed for the ENM risk assessment of ENM safety, i.e. ENM SAFETY CLASSIFIER. This will allow for the crucial transition from descriptive toxicology to predictive toxicology.”
The role of Misvik Biology in Nanosolutions was to adapt selected low throughput toxicity assays to high throughput format. Additionally our task is to develop the specification for a high-throughput platform for the generation of data necessary for a broadly applicable ENM safety classifier tool.
eNANOMAPPER
Grant agreement ID: 604134 (Feb 2014 – Jan 2017)
Objectives
“eNanoMapper proposes a computational infrastructure for toxicological data management of engineered nanomaterials (ENMs) based on open standards, ontologies and an interoperable design to enable a more effective, integrated approach to European research in nanotechnology.
eNanoMapper will support the collaborative safety assessment for ENMs by creating a modular, extensible infrastructure for transparent data sharing, data analysis, and the creation of computational toxicology models for ENMs. Building on recent developments of consortium partners in predictive toxicology, biology and nanotechnology research, we will develop resources, tools and standards for a scientifically sound risk assessment of ENMs that will support the design of new safe and environment-friendly ENMs as well as the assessment of existing materials.”
The role of Misvik Biology in eNanoMapper was to take part and provide expertise on high throughput data specifics for the buildup of a functional database, the development of an ENM applicable ontology and for computational modelling supporting ENM data management and risk assessment.