Research Institute for Applied Bioanalytics and Drug Development

Mission

The major focus of our work is the identification and pharmaceutical optimization of bioactive molecules and biologicals and the preclinical and clinical characterization of drug efficacy and adverse side effects.

Current Research Activities

New therapeutic molecules must meet the safety requirements of regulatory authorities (EMA, FDA) before they are launched to the market. One critical issue is the characterization of adverse side effects and their negative impact on patients’ health. We have started a long-term collaboration with Baxter Innovations GmbH to develop novel technologies and methods for the rapid and reliable testing of adverse side effects in preclinical models and in clinical samples. These technologies must meet the highest quality standards of “Good Laboratory Practice” (GLP), an internationally recognized quality assurance system for laboratory work.

In the current project, we are developing methods to analyze and characterize the immunogenicity of biological drugs (e.g. peptides and proteins). Immune reactions can reduce or completely block the therapeutic efficacy of biologicals and/or elicit severe health problems in the patients. The novel methods must be capable of identifying, characterizing and quantifying different types of adverse immune reactions. One major test is to determine whether the patients develop specific anti-drug antibodies (ADA, Figure 1). In addition, we evaluate important parameters of the immune system such as the release of inflammatory cytokines and the activation of the complement system.

Each drug requires the development of a specific set of test methods. All methods must be validated and meet the requirements of rigorous quality standards and GLP guidelines. In this regard, we have developed quality assurance directives for the documentation of experimental data and reporting to authorities.

Figure 1: Detection of anti-drug antibodies (ELISA, Enzyme-linked Immunosorbent Assay; ADA, anti-drug antibody).

3. Outlook

Currently the pharmaceutical industry is outsourcing research agendas to academic institutions. This trend opens up new perspectives for the IMC University of Applied Sciences in translational and applied biomedical research. The collaboration with the industry will foster the establishment of sustainable scientific communication networks, databases, infrastructure and innovative technologies. Taken together, the Institute of Bioanalytics and Drug Development is likely to turn into a major local technology incubator for the biotech area Krems.