Biomarkers are distinct biological characteristics that can be objectively measured. From a medical point of view, they are indicators of a normal biological or a pathological process in the organism. In medicine, cells, genes, gene products, or certain molecules such as enzymes or hormones, but also complex organ functions or characteristic alterations in biological structures may serve as biomarkers.
Biomarker analysis can be very useful in the development of new drugs. For example, it can enable assessment of the toxic potential of a pharmaceutical, but also of its efficacy. Measurements of biomarkers are also used to describe the course of a disease or the underlying pathological mechanism, or to predict the outcome of therapeutic interventions. However, the development of biomarkers with sufficient predictive value, i.e. sensitivity, is a huge challenge.
The scientists of the Fraunhofer ITEM Department of Biomarker Analysis and Development have taken on this challenge. In close collaboration with their clinical partners at the CRC Hannover, they develop and analyze novel biomarkers. They have access not only to a large biobank containing tissue and blood samples, but also to patient samples collected during clinical trials. These samples may originate from clinical challenge models after pro-inflammatory inhalation challenge with lipopolysaccharides, ozone, ultrafine particles, or allergens, in some cases also from clinical drug trials. In addition, the scientists also use well-characterized samples from patients with respiratory diseases such as COPD, asthma, pulmonary fibrosis, or allergic conditions such as rhinitis. Depending on the particular target, the scientists use samples from peripheral blood, induced sputum, bronchoalveolar lavage (BAL), or exhaled breath and prepare them for measurement of the biomarkers of interest. In addition to special sample preparation, they also test the sample material for purity and stability, thereby controlling its quality.