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Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

Booth number: 4607-5

About us

Fraunhofer ITEM aims to protect man from health hazards in our industrialized world and to contribute to the development of novel therapeutic approaches. Focusing on lung and inhalation, Fraunhofer ITEM has pooled its expertise in three business units: In the business unit Drug Development, we develop and test novel medications against respiratory diseases. Scientific expertise covers manufacturing of biologics, preclinical and clinical development. The business unit Chemical Safety is dedicated to determining the risks from potentially harmful substances.

The business unit Translational Medical Engineering offers many years of experience in the development of medical devices. All business units offer regulatory support. Numerous test systems are available, including in-vitro, ex-vivo and in-vivo. Studies can be performed in compliance with GXP regulations. A Regensburg-based division is dedicated to personalized tumor therapy. Fraunhofer ITEM is one of 67 institutions of the Fraunhofer-Gesellschaft, Europe's leading organization for applied research.

Products and services

GMP manufacturing of biopharmaceuticals for clinical trials:

  • development of API manufacturing processes and GMP
  • biomanufacturing of IMPs including fill and finish
  • Regulatory research and risk assessment

Preclinical research and testing covering efficacy and safety:

  • disease-relevant models (in vitro, ex vivo, in vivo) for efficacy testing of drug candidates in all relevant therapeutic areas (e.g. COPD, asthma, and infection) of respiratory medicine
  • toxicology
  • toxicokinetic
  • and safety pharmacology models for risk assessment
  • and registration of drug candidates

Respiratory clinical trials:

  • allergen challenge chambers
  • inhaled allergen challenge
  • segmental challenge by bronchoscopy
  • exercise testing
  • human samples
  • biomarker analysis
  • inon-invasive MRI techniques
  • patient/ volunteer database and professional recruitment
Ex vivo models for lung diseases with precision-cut lung slices (PCLS)

Ex vivo models for lung diseases with precision-cut lung slices (PCLS)

Main features of respiratory diseases can be displayed ex vivo by using fresh lung tissue, so-called precision-cut lung slices (PCLS). PCLS contain epithelial cells, fibroblasts, smooth muscle cells, nerve fibers, and even immune cells such as antigen-presenting cells and T-cells. The tissue is fully viable. Cells in the tissue interact with each other, thereby reflecting the highly specialized function of the lung.

 Toxicological testing

Toxicological testing

A broad range of toxicological tests enabling assessment of potential risks is offerd to our clients. Substances we investigate include pharmaceuticals such as traditional chemically synthesized drug products, biopharmaceuticals, phytopharmaceuticals, vaccines, and ATMPs.

CLINICAL RESEARCH CENTER HANNOVER Early-phase and proof-of-concept unit

CLINICAL RESEARCH CENTER HANNOVER Early-phase and proof-of-concept unit

The CRC Hannover, which opened in 2014, maximizes benefits for patients by enabling leading academic experts to pool their expertise and collaborate. Our focus is on airway diseases such as asthma, allergic rhinitis, COPD, and interstitial lung diseases, in particular idiopathic pulmonary fibrosis.

News & Innovations

Scientists discover new mechanisms of early metastatic spread in breast cancer 

(Hannover/Regensburg, Germany) Scientists of the Regensburg-based Project Group for Personalized Tumor Therapy (Fraunhofer ITEM/University of Regensburg) and colleagues from Icahn School of Medicine at Mount Sinai discovered new mechanisms of early metastatic spread in breast cancer. Results hav...| » Further reading 

Fraunhofer ITEM takes over and continues development of inhalation technology assets from Takeda 

(Hannover, Germany) The Fraunhofer-Gesellschaft, on behalf of the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, has signed an asset transfer agreement with Takeda GmbH to exclusively transfer its Surfactant and Continuous Powder Aerosolization (CPA) program assets to Fraunh...| » Further reading 


Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Nikolai-Fuchs-Str. 1
30625 Hannover

Phone: +49 495 1153500

Annegret Seehafer
Head of Business Development/Marketing

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