Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

Fraunhofer ITEM Organoid & Tissue Research Center

Human-based Pharmacology of Tomorrow: Human Tissues, Organoids and Macrophage-based Immune Pharmacology

© Fraunhofer ITEM

Organoid & Tissue Research Center

Human-based Pharmacology & Toxicology in a Clinically Relevant Context

The Fraunhofer ITEM Organoid & Tissue Research Center provides an integrated platform for human-relevant preclinical research, combining native tissue slices, organoids and standardized iPSC-derived immune cell modules. By preserving tissue architecture, donor-specific biology and disease-relevant cellular interactions, these models offer a powerful basis for studying efficacy, safety and mechanisms of action in human-relevant systems.

Building on Fraunhofer ITEM’s established expertise in precision-cut lung slices, the center extends human ex vivo modelling to further organ systems such as intestine, liver and heart. Together with scalable organoid technologies and macrophage-based immune pharmacology, the platform enables tailored assays for inflammation, fibrosis, infection, repair and tissue-specific toxicity.

With its modular service portfolio, the center supports pharmaceutical, biotech and academic partners in translational drug development, from study design and model selection to functional readouts, imaging, omics and interpretable donor-level analyses.

A Modular Offering: Native Human Tissues, Scalable Organoids and Standardized Macrophage Modules

At Fraunhofer ITEM we bring together decades of internationally recognized expertise in native human tissues, scalable organoids and standardized macrophage modules – providing collaborators with access to complementary human-relevant models from a single scientific framework.

© Fraunhofer ITEM

Native Tissue Slices

Lung, intestine, liver and heart tissues retain architecture, resident immune cells and donor-specific biology.

© Fraunhofer ITEM

Organoids

Cardiac and epithelial organoids enable scalable efficacy, safety and disease modelling.

© Fraunhofer ITEM, Ingrid Senne

Macrophage modules

iPSC-derived macrophages provide reproducible immune competence and mechanistic activation readouts.

One Integrated Service Platform for Translational Drug Development

Human Translational Assays

  • Study concepts matched to indication, modality and decision point
  • Fresh donor material with tissue-specific functionality
  • Controlled exposure designs and reference controls

Mechanistic Evidence Packages

  • Inflammation, fibrosis, infection, repair, toxicity
  • Functional, omics and imaging readouts
  • Interpretable donor-level analyses
  • Controlled exposures and reference controls

De-risking for Complex Modalities

  • Biologics, RNA medicines, ATMPs and immunomodulators
  • Macrophage-mediated activation and cytokine release profiling
  • Tissue-specific safety and efficacy context controls