Department of Therapy Validation

In the department of therapy validation we focus on the development and validation of novel therapeutic approaches and diagnostic methods. We cover the following topics:

  • Identification and validation of new protein biomarkers for diagnostic and therapeutic applications
  • Development and production of specific monoclonal antibodies and assays for detect biomarkers
  • Development of human therapeutic monoclonal antibodies for the treatment of tumorigenic and autoimmune diseases
  • Planning and execution of preclinical efficacy and safety studies for new drug candidates, ATMPs and medical devices under GLP or GLP-analogous conditions
  • Small-scale GMP production of therapeutic monoclonal antibodies for preclinical animal studies and clinical trials (Phase I and II)
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. 

 

Study-accompanying Immunodiagnostics

The Department of Therapy Validation performs study-associated preparation, storage and diagnostics of patient samples under GLP and GLP-analogous conditions.

 

Antibody Production Unit

In recent years, the increasing number of therapeutic monoclonal antibody (mAb) candidates under preclinical and clinical development have required new flexible, efficient, and economic opportunities for GMP production of therapeutic antibody candidates.

 

GLP Test Facility

The Department of Therapy 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.