BB4.7-Safety Assessment

Elias Koumoulos

  • Description

In vitro evaluation of the toxicity of materials (cell viability, cell morphology, oxidative stress, inflammation, etc.). Provision of consultation based on the selected case study materials and limited studies per case if required.

  • Standardisation

OECD, ISO, ICH, FDA, EMA, REACH, and other toxicology-related standards. Good Laboratory Practices.

  • Innovation features

Rapid testing of multiple samples. Tailored combinations of assays for specific materials. Potential use of predictive models for enhanced safety assessment.

Pricing

Depends on quantity of materials and assays to be tested. Approximately, for a material 1000 Euros for 1-2 assays

Service delivery timeframe

1 month per Assay/per material

  • Relevant Industry

Pharmaceuticals & Biotechnology, Medical Devices, Cosmetics & Personal Care, Chemicals & Materials Science, Food & Beverages (for packaging materials), Environmental & Regulatory Agencies

Providers

BIOG3D

IRES

Supporting Services

Risk and Safety assessment service (BB4.6) from IRES

  • Value proposition

Ensures materials comply with safety regulations before market entry.Supports ethical research through in vitro models.Tailored assessments based on case studies and material-specific risks.

  • Environmental and social impact

Supports ethical research practices. Minimizes environmental impact compared to in vivo methods. Ensures products entering the market do not pose health risks.

  • Geographical and/or infraestructure restrictions

EU and international clients (restrictions depend on shipping regulations for hazardous materials). May require specific handling for certain chemicals (e.g., hazardous materials). Clients must ensure proper packaging and legal documentation for sample shipments.

  • Service Support

Material Submission: Clients provide materials for testing.
Study Design & Consultation: Selection of assays based on material type and intended use.
In Vitro Toxicological Testing: Conducts cell viability, morphology, oxidative stress, inflammation assays, etc.
Data Analysis & Interpretation: Scientific reporting with risk assessment.
Consultation & Recommendations: Optional additional guidance for compliance strategies.