Biomarkers

Fraunhofer ITEM’s biomarker laboratory

Biomarkers for diagnosis and therapy

Biomarker analysis
© Fraunhofer ITEM

Like the rest of the Fraunhofer ITEM clinical research facilities, the biomarker laboratory is located at the Clinical Research Center Hannover (CRC Hannover).

In both clinical routine and clinical research, there is an increasing need for identification and development of validated biomarkers permitting early disease diagnosis and prognosis, personalized treatment decisions, and monitoring of treatment responses. Fraunhofer ITEM’s biomarker laboratory is an integral part of the Clinical Research Center Hannover (CRC Hannover). Not only does the laboratory have direct access to patient samples from the outpatient department and the phase-I unit of the CRC Hannover; a pneumatic delivery system directly connects it with clinical departments, the biobank, and the adjacent Hannover Medical School.

Our staff includes technicians and scientists with long-term experience in biomarker analysis. We have in-depth experience with materials from the lung, such as induced sputum, bronchoalveolar lavage fluid, and exhaled breath. Focuses of our research are on the customization of biomarker assays to meet our clients’ special requirements and on the development of new methods.

We work in compliance with GLP and GCLP and have an independent quality assurance unit, as we consider industry standards for biomarker measurement to be an important prerequisite for achieving regulatory acceptance of endpoints in clinical trials.

Services and expertise in biomarker analysis

Our expertise

 

Owing to our own large patient community, our biobank, and our collaboration with the Hannover Medical School, we have experience with and access to a broad spectrum of well-characterized human samples:

 

Induced sputum

Bronchoalveolar lavage

Bronchial biopsies and brushings

Bronchosorption 

Nasal specimens (brushings, scrapings, filter paper, and lavage)

Exhaled breath and exhaled particles

Skin blister fluid and skin biopsies

Peripheral blood

Our technologies

 

We process and analyze human biospecimens using a broad variety of innovative technologies and methods, including in-vitro disease models using primary cells:

 

Chip cytometry

Flow cytometry

Cell sorting

Immunological and cell-based assays

Metabolomics

Meso Scale Discovery multiplex platform

ELISA

PCR, gene expression array

Immunohistochemical investigations

 

Chip cytometry

Chip-based cell analysis, i.e. chip cytometry, enables iterative staining of cellular markers like in flow cytometry, but in addition allows analyses in stored samples.

Assay development and validation

The use of validated assays is crucial for pharmacokinetic and pharmacodynamic evaluations in clinical trials. Based on our extensive experience, we develop and validate novel assays meeting the highest quality criteria under the relevant GCP, GLP, and ICH guidelines.

 

Examples of validation and assay implementation experience:

Validation of ELISA to measure interleukin-8, MCP-1, tumor necrosis factor α, MMP-9, and GROa in human bronchoalveolar lavage fluid
Measurement of eosinophil shape change using flow cytometry
Measurement of CRP in human bronchoalveolar lavage fluid

Validated assays are crucial for pharmacokinetic and pharmacodynamic evaluations in clinical trials.
© Fraunhofer ITEM

Validated assays are crucial for pharmacokinetic and pharmacodynamic evaluations in clinical trials.