Department of Preclinical Development and Validation

The main goal of the Department of Preclinical Development and Validation is the concentration of expertise for the preclinical validation of novel therapeutic approaches at IZI, to maximize the efficiency in developing new in vitro or in vivo models and their application in preclinical studies. Since the department manages the GLP test facility of Fraunhofer IZI, all preclinical studies ( even those in other Fraunhofer IZI departments ) can be performed under GLP.

The department covers the following topics#

  • 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.
  • Developing procedures for the diagnostic analysis of secretory and cellular protein biomarkers, including the development and production of specific monoclonal antibodies for their detection and finally the development and validation of the respective diagnostic assays (e.g. ELISA, lateral flow assays, Luminex®, flow cytometry). 
  • Identifying and validating new protein biomarkers for diagnosis and therapy of chronic-inflammatory and tumor diseases, as well as for the sector of veterinary medicine / farm animal husbandry.
  • Developing human monoclonal antibodies to be directed against new therapeutic tumor targets (triple-negative breast cancer) and to be used as passive vaccines against pathogenic viruses (SARS-CoV-2) besides their further development as drug candidates.
Therapy Validation
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Protein Biomarker Unit

The Protein Biomarker Unit focuses on the identification and validation of proteins to be used as diagnostic biomarkers or representing therapeutic targets. Moreover, the unit aims at the development of single and multiplex assays for their detection.

Preclinical Models Unit

The Preclinical Model Unit is concerned with the design and implementation of preclinical efficacy and safety studies for new drug candidates under GLP or GLP-analogous conditions. 

GLP Test Facility

The Department of Preclinical Development and Validation enables the design and performance of preclinical efficacy and safety studies for novel drug candidates (especially Advanced Therapy Medicinal Products, ATMPs) and medicinal products (ISO 10993) under GLP or GLP-analogous conditions.