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Immunocheck / Biomarkers

In the Core Unit Immunocheck / Biomarkers, we develop, validate and explore immunological biomarkers to accompany new treatment approaches in pharma-sponsored and investigator-initiated trials and develop stratification parameters for the personalization of immunological and regenerative therapies (Precision Medicine).

To guarantee the high regulatory standards of an accredited laboratory for the analysis of biosamples from clinical approval studies and to ensure the necessary flexibility in the development of new tests and explorative clinical studies, the Core Unit is structurally divided into two subunits with different requirement profiles and subtasks, but which are closely linked to each other:

  • Subunit A: Immunological Study Lab (ISL)
  • Subunit B: Biomarker Development and Exploration Lab (DEL)


The Immunological Study Lab (ISL) is a DAKKS-accredited laboratory that is compatible with EMA/FDA standards. The laboratory carries out immunological tests to analyze patient samples from clinical trials, performs validation studies for immunological test systems, and offers advice on selecting appropriate immunological biomarkers for monitoring clinical trials.

Because of the lab’s close link to the scientific environment of the research groups at both the Institute for Medical Immunology and the BCRT, newly discovered biomarkers can be quickly transferred to validated test systems. Our proximity to and long-standing close collaboration with the Charité Research Organization (CRO) means that delicate blood samples from clinical studies can be evaluated with sensitive pre-analytics, and abnormal, clinically relevant findings can be communicated in a direct and speedy manner. ISL was and still is involved in contract research collaborations with numerous pharmaceutical and biotechnology companies, including, among others, Baxter, Bayer, Novo Nordisk, Boehringer Ingelheim, Sanofi, Novartis, Biogen, Pluristem and Apceth.

The scientists of the Biomarker Development and Exploration Lab (DEL) advice, select and pre-test (in vitro and in vivo) potential biomarker candidates in advance of clinical trials to make them ready for transfer into ISL. We develop new tests and perform feasibility and validity testing in explorative clinical biomarker studies (PoC) and explore new test platforms for the application of biomarker analysis in clinical trials in terms of feasibility and validity. In addition, we analyze and explore any safety concerns that arise in the application of new therapeutics and develops possible solutions (e.g. cytokine release induction, immunotoxicity).

Focus

1. Validation studies on immunological parameters and functional analyses on, inter alia:

  • precision (intra-assay/inter-assay variations, analyst-to-analyst comparisons) 
  • robustness (age of blood, age of stain, freeze/thaw storage conditions, matrix effects)
  • linearity/range
  • inter-individual variation/standard value surveys
  • preparation of validation plans and reports.


2. Analysis of patient samples using validated immunological test systems in the context of clinical trials for internal and external partners.     

 3. Validation and performance of special immunological tests developed either by the sponsor or by the laboratory itself for pharmacokinetic, pharmacodynamic and safety studies in the context of clinical trials (phase I-III):    

  • immunophenotyping, also of special subpopulations (10-color flow cytometry)
  • receptor occupancy, also of subpopulations, by biologics (10-color flow cytometry)
  • detection of anti-drug antibodies (ligand assays)
  • immunologic function tests (ex vivo recording of various immune cell functions with different platforms)
  • in vitro/ex vivo functional testing of blocking agents in ligand stimulation assays
  • multiplex measurement of cytokines in body fluids.


4. Advising internal and external partners on the selection of appropriate immunological biomarkers and test systems for monitoring clinical trials.

5. Close cooperation with the biomarker development laboratories of the Institute for Medical Immunology and the BCRT (Prof. Volk, Prof. Reinke, Prof. Sawitzki, Prof. Thiel, Prof. Babel).

Range of Methods & Services

1. Standard hematological parameters (WBC, lymphocytes, monocytes) using the COULTER® AC•T™ 5diff hematology analyzer  

 2. 10-color flow cytometry using the Navios flow cytometer 

     (Beckman Coulter) 

  • immunophenotyping, also of special subpopulations
  • receptor occupancy by biologics
  • read-out for function tests
  • expert analysis of flow cytometry data (FlowJo or Kaluza® software)


3. Safety markers

  • HLA-DR monocytes (over-immunosuppression)
  • viral load/virus-specific immune response (over-immunosuppression) *
  • tuberculosis-specific interferon secretion (ligand assay) *

4. Detection of anti-drug antibodies using semi-quantitative ELISA methods

5. Multiplex measurement of cytokines ** 

6. RT-PCR analysis of immunologically relevant markers *

7. Function tests:

  • ex vivo stimulation via Toll-like receptors (ligand assays)
  • ex vivo stimulation via T cell receptors (ligand assays, flow cytometry, EliSpot *)
  • phagocytosis/burst activity *
  • NK cell function test * 

under sub-contract

** in the validation phase

Team

Prof. Dr. med. Hans-Dieter Volk
Scientific Head 
Phone: +49 (0)30 450 539 500
Fax: + 49 (0)30 450 524 902
E-Mail: hans-dieter.volkcharitede 

PD Dr. rer. nat. Gerald Grütz
Scientific and Technical Head Immunological Study Lab (ISL)
Phone: +49 (0)30 450 524 250
Fax: + 49 (0)30 450 524 932
E-Mail: gerald.gruetzcharitede

Dr. Kerstin Jülke
Scientific and Technical Head Biomarker Development and Exploration Lab (DEL)
Phone: +49 (0)30 450 524 304
Fax: + 49 (0)30 450 524 932
E-Mail: kerstin.juelkecharitede


Dr. Levent Akyüz
Scientific Assistant
Head of „Durchflusszytometrie“
Phone: +49 (0)30 450 659 838
Fax: + 49 (0)30 450 524 906
E-Mail: levent.akyuezcharitede 

Dr. Inga Gebuhr
Scientific Assistant
Phone: +49 (0)30 450 524 339
Fax: + 49 (0)30 524 932
E-Mail: inga.gebuhrcharitede

Dr. Maura Farinacci
Scientific Assistant
Phone: +49 (0)30 450 524 339
Fax: +49 (0)30 450 524 932
E-Mail: maura.farinaccicharitede

Dr. Anja Heiduk
Scientific Assistant
Head of "Lösliche Faktoren"
Phone: +49 (0) 30 450 659 728
Fax: +49 (0) 30 450 524 906
E-Mail: anja.heidukcharitede

Dr. Su-Jin Park
Scientific Assistant
Head of „Qualitätsmanagement“
Phone: + 49 (0)30 450 524 338
Fax: + 49 (0)30 450 524 906
E-Mail: su-jin.parkcharitede 

Andreas Wilhelm
Scientific Assistant
Phone: + 49 (0)30 569 638
Fax: + 49 (0)30 450 524 906
E-Mail: wilhelm.andreascharitede 

Sabine Biedermann
Technical Assistant
Phone: + 49 (0)30 450 659 758
Fax: + 49 (0)30 450 524 256
E-Mail: sabine.biedermanncharitede 

Florian Butke
Technical Assistant
Phone: + 49 (0)30 559 758
Fax: + 49 (0)30 450 524 962
E-Mail: florian.butkecharitede 

Sabine Brösel
Technical Assistant
Phone: +49 (0)30 450 659 758
Fax: + 49 (0)30 450 524 906
E-Mail: sabine.broeselcharitede

Karolina Grzeschik
Funktion: Technische Asisstentin
Phone: +49 (0)30 450 524 306
Fax: + 49 (0)30 450 524 932
E-Mail: Karolina.Grzeschikcharitede

Rebecca Noster
Funktion: Technische Assistenten
Phone: +49 (0)30 450 524 308
Fax: + 49 (0)30 450 524 932
E-Mail: rebecca.nostercharitede

Nezlisah Yasmum
Technical Assistant
Phone: +49 (0)30 450 659 758
Fax: + 49 (0)30 450 524 906
E-Mail: nezlisah.yasmumcharitede

Eileen Hilprecht
Documentation Assistant
Phone: +49 (0)30 450 659 638
Fax: + 49 (0)30 450 524 906
E-Mail: eileen.hilprechtcharitede

Anja Kuckuck
Documentation Assistant
Phone: +49 (0)30 450 659 638
Fax: + 49 (0)30 450 524 906
E-Mail: anja.kuckuckcharitede

Monja Priebusch
Documentation Assistant
Phone: +49 (0)30 450 659 638
Fax: + 49 (0)30 450 524 906
E-Mail: monja.priebuschcharitede