The department covers the following topics:
1) Planning and execution of preclinical efficacy and safety studies for new drug candidates (especially ATMPs) and medical devices (ISO 10993) under GLP or GLP-analogous conditions. This includes the development and validation of suitable in-vitro and in-vivo models.
2) Developing and optimising methods and processes for the diagnostic analysis of secretory and cellular protein biomarkers. This includes the development and production of specific monoclonal antibodies for detecting these biomarkers, as well as the development and validation of the corresponding diagnostic assays (e.g. ELISA, Luminex®, multicolour flow cytometry).
3) Identifying and validating new protein biomarkers for diagnosis and therapy of chronic inflammatory and tumour diseases, as well as for the sector of veterinary medicine / animal husbandry.
4) Developing human therapeutic monoclonal antibodies for the treatment of tumour and autoimmune diseases, as well as passive vaccines against bacterial toxins and pathogenic viruses, and their advancement to drug candidates.
5) Small-scale GMP production of therapeutic monoclonal antibodies for preclinical animal studies and clinical trials (Phase I and II).
- GLP certified since 2009
- Testing Category 9: Immuntoxicity / immunogenity in vitro / in vivo
- Safety tests for ATMPs – biodistribution, tumorigenicity and immungenity / immunotoxicity