Study-accompanying Immunodiagnostics Unit

The Department of Therapy Validation performs study-associated preparation, storage and diagnostics of patient samples under GLP and GLP-analogous conditions. Optimized strategies from sampling and transport to sample storage and various analytical methods are developed. The quality of samples is at the center of activities, to ensure optimal diagnostic results and preservation of the samples during long-term storage.

Companion diagnostic for a clinical trial (Phase III) to evaluate the immunotherapeutic DCVax®-L for the treatment of Glioblastoma Multiforme

DCVax®-L (Northwest Biotherapeutics GmbH) is a therapeutic agent based on endogenous immune cells that will be used for treating Glioblastoma Multiforme after standard therapy. The treatment is based on immune cells of the peripheral blood which are differentiated in-vitro to specific antigen-presenting cells, dendritic cells (DCs). The immature DCs are subsequently brought into contact with a tumour lysate, and thereby "trained" to recognize tumour cells. The maturated DCs are injected into the patient and can then trigger an immune response against remaining tumour cells. As part of a clinical trial (Phase III) to test the efficacy of DCVax®-L, cells from patients' peripheral blood (peripheral blood mononuclear cells; PBMCs) are isolated, quality controlled and cryopreserved for long-term storage. The aim of the project is to develop suitable diagnostic assays which can demonstrate a functional immune response in patients after treatment with DCVax®-L to support clinical data.

Project manager
Dr. Ulla Schwertassek

Completed projects

  • Companion diagnostics to determine Mucin-1 reactive antibodies and immune cells in patients' blood after treatment with CVac™
  • Companion diagnostics to determine the immune status of patients with acute diarrhea after treatment with Arhama® Tinktur N
  • Testing of a local bactericidal treatment after tick bites in a Borrelia infection model