Department of Preclinical Development and Validation

Jörg Lehmann

Dr. rer. nat.
Head of Department of Preclinical Development and Validation, Head of GLP test facility

  • Education / training

    1989 
    University of Leipzig, Leipzig, Germany
    Diploma in Biology (equivalent to M.Sc.)
    B-cell stimulation, immunotoxins

    1994
    Fraunhofer Institute for Toxicology and Aerosol Research, Hannover and University of Leipzig, Leipzig, Germany
    Dr. rer. nat. (Ph.D.)
    T-cell regulation in Leishmania donovani infection (Th1/Th2)

    2004
    German Society of Immunology (DGfI), Lübeck
    Fachimmunologe DGfI (Consultant Immunologist, German Society of Immunology, DGfI)
    Immunity to infection (Th1/Th2),  Immunotoxicology /  Immunopharmacology,  Experimental Rheumatology, Monoclonal Antibodies

    Recent research activities

    • Immunity to Salmonella enterica
    • Arylhydrocarbon receptor research – Immunotoxicology and therapy development
    • Chronic inflammatory bowel disease – models and therapy development
    • Immune oncology – models and development of therapeutic antibodies
    • Development of GLP-conform testing strategies for ATMPs, medical devices and combined ATMPs

    Positions and honors

    1989
    Arno Wetzel Award for best Diploma Thesis, University of Leipzig

    1990-1993
    Fraunhofer Institute for Toxicology and Aerosol Research ITA, Hannover / University of Leipzig, PhD student (Supervisors: Prof. Dr. Marie-Luise Lohmann-Matthes, Fraunhofer ITA; Prof. Dr. Karl Drößler, University of Leipzig)

    1994-1996
    University of Leipzig, Medical Faculty, Institute for Clinical Immunology and Transfusion Medicine (Head: Prof. Dr. Frank Emmrich), Postdoc

    1995
    University of Texas, Southwestern Medical School of Dallas, Cancer Immunobiology Center, TX, USA, Research visit, Postdoctoral work with Prof. Dr. Nancy Street

    1996-2001
    University of Leipzig, Faculty of Veterinary Medicine, Institute of Immunology (Head: Prof. Dr. Gottfried Alber), Scientific Assistant/Assistant Lecturer in Veterinary Immunology

    2001
    University of Cambridge, UK, Research visit, Collaboration with Dr. Pietro Mastroeni and Dr. Duncan Maskell

    2001-2005
    Labor Diagnostik GmbH Leipzig (SME) / Priontype GmbH&Co. KG (SME), Leipzig, Head of Research & Development / Dept. Immunology

    2003
    Northern Ireland Government, Dept. of Agriculture and Rural Development, Research visit, Collaboration with Dr. Alastair Douglas

    2006-date
    Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig,

    2006-2015
    Head of Cell Engineering/GLP unit

    2009-2015
    Deputy Head of Department Cell Engineering

    2008-date
    Head of GLP test facility

    2016-2021
    Head of Department Therapy Validation

    2016-2017
    Head of Manufacturing GMP Therapeutic Antibodies

    2017-2019
    Deputy Head of Manufacturing GMP Therapeutic Antibodies

    2019-2020
    Head of Manufacturing GMP Biopharmaceuticals

    2021-date
    Head of Department Preclinical Development and Validation

    2009-date
    Assistant Lecturer in Immunology for Pharmacists, University of Leipzig, Faculty of Biological Sciences, Pharmacy, and Psychology; since 2018: Medical Faculty

    2012-date
    Assistant Lecturer in Good Laboratory Practice, post-gradual M.Sc. program „Clinical research and translational medicine“, University of Leipzig, Medical Faculty

    2018-date
    Assistant Lecturer in Immunotoxicology, post-gradual M.Sc. program „Toxikologie und Umweltschutz“ / Modul „Immuntoxikologie “, University of Leipzig, Medical Faculty

    Memberships / societies

    • Deutsche Gesellschaft für Immunologie e.V., DGfI
    • Gesellschaft für Versuchstierkunde e.V. Society of Laboratory Animal Science, GV-SOLAS
    • Deutsche Gesellschaft für Toxikologie e.V. (GT)
    • Deutsche Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie (DGPT)
    • German QP Association

    Patents

    • Lehmann J, Emmrich F, Sack U. Autonomously growing, invasive fibroblast-derived cell line. EP-Patent, Pat.-Nr. 00 11 1698.7-2116
    • Engemann C, Hoeschler K, Lehmann J, Gabert J. Procedure for enrichment and detection of variant prion proteins (PrPSc). German Patent, Pat.-Nr. 102 30 141.7
    • Engemann C, Hoeschler K, Lehmann J, Gabert J, Krummrei U. Procedure for enrichment and detection of pathological altered prion proteins (PrPSc). PCT-Patent, PCT/DE03/02249
    • Engemann C, Krummrei U, Lehmann J. Procedure for preparation of body fluids as a prerequisite for detection of pathological altered prion proteins (PrPSc). German Patent, Pat.-Nr. 103 54 207.8
    • Lehmann J, Zoldan K. Verfahren und Vorrichtung zur Überwachung des Gesundheitszustands von Milchkühen. German Patent-Anmeldung, Pat.-Nr. F30787DE; PCT-Anmeldung, PCT F30787WO; Internationale Anmeldung PCT/EP2016/063109, WO 2016/198501 A1
    • Ueberham E, Havenith H, Spiegel H, Schillberg S, Lehmann J. Means and methods for detecting soy allergens. German Patent application, Pat.-Nr. 10 2018 217 447.4, PCT-Anmeldung/EP2019/077598

Stefan Kalkhof

Prof. Dr. rer. nat.
Head of Proteomics Unit, Deputy Head of Department of Preclinical Development and Validation

Stefan Kalkhof
© Fraunhofer IZI
  • Education / training

    2004
    University of Leipzig, Leipzig, Germany
    Diploma in Chemistry (equivalent to M.Sc.)
    Protein-Ligand Interaction with Ion Cyclotron Resonance Mass Spectrometry

    2004-2008
    University of Halle, Halle, Germany / Vanderbilt University, Nashville, USA
    Dr. rer. nat. (Ph.D.)
    Investigation of the Laminin self-interaction by chemical cross-linking, mass spectrometry, and computational modelling

    Recent research activities

    • Development and application of LC-MS based proteomics techniques (protein quantification, protein-protein-interaction, protein-small molecule interaction, PTMs)
    • Testing and optimization of biomaterials for clinical application (cell interaction, drug release, biodegradation)
    • Elucidation of disease mechanism and drug response (wound healing, kidney diseases)

    Positions and honors

    Since 2021
    Deputy Head of the Department of Preclinical Development and Validation, Fraunhofer IZI, Leipzig

    Since 2021
    Spokesman of the research priority program of the HAW Coburg, “Analyzing and Promoting Health”

    Since 2017
    Director of the Institute for Bioanalytics, HAW Coburg, https://bioanalytik.co/

    Since 2016
    Research Professor for Instrumental Bioanalytics, HAW Coburg, www.hs-coburg.de/Kalkhof

    Since 2016
    Head of the Fraunhofer Unit “Proteomics”, Fraunhofer IZI

    Since 2015
    Professor for Instrumental Bioanalysis, Faculty of Applied Natural Sciences and Health, HAW Coburg

    2010
    "Science Award" of Bayer Bitterfeld GmbH

    2008-2016
    Head of the research group "Mass Spectrometry", Department of Proteomics, Helmholtz Centre for Environmental Research – UFZ Leipzig

    2004-2008
    PhD thesis at the Chair of Pharmaceutical Chemistry, Institute of Pharmacy, Martin Luther University Halle-Wittenberg, Supervisor: Prof. Dr. Andrea Sinz

    2006
    Research stay at Vanderbilt University, Center for Structural Biology, Nashville, USA, Research Group Prof. Dr. Jens Meiler

    2004
    Diploma thesis in the junior research group "Protein-Ligand Interaction with Ion Cyclotron Resonance Mass Spectrometry" at the Faculty of Biochemistry, University of Leipzig

    2002/5-7
    Research stay, project “investigation of drug encapsulation using secondary ion mass spectrometry”, University of Antwerp, Belgium, research group Prof. Dr. L. van Vaeck

    2002/2-5
    Internship, Bayer AG, Central Research, Leverkusen

    Memberships / societies

    • Gesellschaft Deutscher Chemiker eV
    • German Society for Mass Spectrometry DGMS
    • American Society for Mass Spectrometry
    • Tissue Engineering and Regenerative Medicine International Society
    • Society of Environmental Toxicology and Chemistry

    Publications

Sina Riemschneider

Dr. rer. nat.
Head of Toxicology and Immunotoxicology Unit

Sina Riemschneider
© Fraunhofer IZI
  • Education / training

    2023 
    Fraunhofer Institute of Cell Therapy and Immunology and University of Leipzig, Leipzig, Germany
    Dr. rer. nat.
    Immunomodulating effects of aryl hydrocarbon receptor ligands

    2012
    Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany
    Biology - Master of Science
    Effects of benzo(a)pyrene on activation process of murine macrophages

    2010
    Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany
    Biology - Bachelor of Science 
    Molecular basics of cadmium and formaldehyde detoxification in E. coli 

    Recent research activities

    • Study director for GLP-compliant studies for different test items like ATMPs
    • Arylhydrocarbon receptor research – Immunotoxicology and therapy development
    • Chronic inflammatory bowel disease – models and therapy development

    Positions and honors

    2021 – date
    Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Head of Toxicology and Immunotoxicology Unit

    2019–2021
    Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Head of Preclinical Models Unit

    2017–2019
    Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Deputy Head of Preclinical Models Unit

    2018 – date
    Assistant Lecturer in preclinical models, post-gradual M.Sc. program "Clinical research and translational medicine", University of Leipzig, Medical Faculty

    2018–2019
    Assistant Lecturer in Immunotoxicology, post-gradual M.Sc. program "Toxikologie und Umweltschutz" / Modul "Immuntoxikologie", University of Leipzig, Medical Faculty

    2017 – date
    Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Study director of the GLP test facility

    2013–2023
    Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Department of Preclinical Development and Validation, PhD program

    Memberships / societies

    • German Society for Immunology

    Publications

Anke Hoffmann

Dr. med. vet.
Deputy Head of Toxicology and Immunotoxicology Unit

  • Education / training

    2012 
    University of Leipzig, Faculty of Veterinary Medicine, Institute of Anatomy, Histology and Embryology
    Specialist in Veterinary Anatomy
    Theoretical and practical training to become a specialist in Veterinary Anatomy

    2001 
    University of Leipzig, Faculty of Veterinary Medicine, Institute of Anatomy, Histology and Embryology
    Dr. med. vet. (DVM)
    Neuroanatomical research, immunohistochemical methods, light and electron microscopy

    1997 
    Free University of Berlin, Berlin, Germany
    Veterinarian
    Curriculum of Veterinary Medicine

    Recent GLP study activities

    • Conducting the pathohistologic study phase of preclinical studies to demonstrate safety and efficacy or to exclude immunotoxicologic effects under GLP conditions in short- and long-term studies
    • Pathohistologic studies on systemic and local side effects of various test items such as biodegradable polycaprolactone scaffolds, therapeutic HBV vaccines, ATMPs, drug-coupled nanoparticles
    • Routine staining and immunohistochemical studies
    • Toxicopathological section evaluations and quantifications using image analysis software programs

    Positions and honors

    2023
    Assistant Lecturer in Immunotoxicology, post-gradual M.Sc. program "Toxikologie und Umweltschutz"/ Modul "Immuntoxikologie", University of Leipzig, Medical Faculty

    2019 – to date
    Assistant Lecturer M.Sc. program "Bioanalytik", Faculty of Applied Natural Sciences and Health at Coburg University of Applied Sciences

    2018 – to date
    Assistant Lecturer Modul "Biologicals – Von der Entwicklung zur Anwendung", M.Sc. program "Pharmazeutische Biotechnologie", Faculty of Natural and Environmental Sciences, University of Applied Sciences Zittau-Görlitz

    2017 – to date
    Fraunhofer Institute for Cell Therapy and Immunology IZI Leipzig (Head: Prof. Dr. Dr. Ulrike Koehl), Department of Preclinical Development and Validation (Head: Dr. Joerg Lehmann), Deputy Head of Toxicology and Immunotoxicology and Scientific Assistant

    2013–2017
    Vita 34 AG, Leipzig, Head of the Research and Development group, Referee

    2003–2013
    University of Leipzig, Faculty of Veterinary Medicine, Institute of Anatomy, Histology and Embryology (Head of Institute of Histology and Embryology: Prof. Dr. Johannes Seeger), Scientific Assistant

    2000–2003
    GenPat77 Pharmacogenetics AG, Berlin (Head: Prof. Dr. Nalân Utku), Scientific Assistant

    Publications

Claudia Müller

M. Sc.
Head of Inflammation and Tumor Models Unit

Claudia Müller
© Fraunhofer IZI
  • Education / training

    2012 
    Brandenburg University of Technology (BTU) Cottbus-Senftenberg, University of Applied Sciences, Germany
    Biotechnology - Bachelor of Science
    Hybrid pig versus Göttingen minipig-derived cartilage and chondrocytes show pig line-dependent differences 

    2014 
    Charite University Medicine Berlin, Germany
    Toxicology - Master of Science
    Establishment of an in vitro assay for the detection of cytokine production in activated T cells

    Recent research activities

    • Tumor – models and therapy development
    • Humanized immune system mouse model
    • Antibody development
    • Study director for GLP-compliant studies for ATMPs and combined ATMPs

    Positions and honors

    Since 2015
    PhD program at Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig Department of Preclinical Development and Validation

    2017 – date
    Study director of the GLP test facility

    2021 – date
    Head of the working group "Inflammation and Tumor Models" at Fraunhofer IZI, Department of Preclinical Development and Validation

    2018 – date
    Assistant Lecturer in preclinical models, post-gradual M.Sc. program „Clinical research and translational medicine“, University of Leipzig, Medical Faculty

    2018 – date
    Assistant Lecture in preclinical models, Pharmaceutical Biotechnology Master's Degree, Hochschule Görlitz/Zittau

    Awards and activities

    2015 – 2017
    Fraunhofer Career Development Program “Talenta” of Fraunhofer

    2017
    Publication Award 2017 (Fraunhofer IZI; Science Day)

    Publications

Susanne Przybylski-Wartner

Dr. rer. nat.
Deputy Head of Inflammation and Tumor Models Unit

  • Education / training

    2012 
    Martin-Luther University Halle-Wittenberg, Germany
    Diploma in Biochemistry (equivalent to M.Sc.)
    Production of proteins, FRET measurements of fluorescent proteins

    2020 
    University of Leipzig, Leipzig, Germany
    Dr. rer. nat (Ph.D.)
    Nanoparticle-mediated transfection in immune cells (t cells), gene therapy of immunological diseases

    Recent research activities

    • Therapy development for inflammatory bowel disease (IBD) in vitro and in vivo
    • Nanoparticle-mediated transfection
    • Study director for GLP-compliant studies for different test items (ATMPs, small molecules)

    Positions and honors

    2013–2015
    Scientific employee at Saxonian Incubator for Clinical Translation, University Leipzig

    2016–2019
    Scientific employee and deputy group leader of the working group "OpTcell", Department Cell Therapy at Fraunhofer IZI, Leipzig

    2013–2020
    PhD studies in clinical Pharmacology, Medicine faculty, University Leipzig

    2019 – date
    Deputy group leader of working group "Inflammation and Tumor Models" and study director for GLP-compliant studies at Fraunhofer IZI, Department of Preclinical Development and Validation, Leipzig

    Publications

Johannes Schmidt

Dr. rer. nat.
Deputy Head of Proteomics Unit

  • Education / training

    2017 
    Helmholtz Centre for Environmental Research – UFZ and University of Leipzig, Leipzig, Germany
    Dr. rer. nat.
    Molecular effects of GAG-modified scaffolds in bone regeneration

    2013 
    University of Rostock, Rostock, Germany
    Microbiology and Biochemistry - Master of Science
    Proteomics methods in the analysis of preclinical samples

    2011
    University of Rostock, Rostock, Germany
    Bio Sciences - Bachelor of Science 
    Mass spectrometry-based methods in the quantification of Rituximab in patients plasma 

    Recent research activities

    • Development and testing of functionalized scaffolds for clinical application in bone regeneration
    • Method development for proteomics analysis of preclinical and clinical samples 

    Positions and honors

    2019 – date
    Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Deputy Head of Proteomics Unit

    2017–2019
    Helmholtz Centre for Environmental Research (UFZ), Leipzig, Postdoctoral fellow in the Department of Molecular Systems Biology

    2013–2017
    Helmholtz Centre for Environmental Research (UFZ), Leipzig, PhD candidate in the Department of Proteomics
    Department of Preclinical Development and Validation, PhD program

    Memberships / societies

    • American Society for Mass Spectrometry (ASMS)

    Publications

Christiane Storch

Dr. med. vet.
Research scientist Toxicology and Immunotoxicology Unit

  • Education / training

    2023 
    University of Leipzig, Faculty of Veterinary Medicine, Institute of Physiological Chemistry, Endocrinology
    Specialist in laboratory animal science
    Theoretical and practical training to become a specialist in laboratory animal science

    2022 
    University of Leipzig, Faculty of Veterinary Medicine, Institute of Physiological Chemistry, Biochemistry
    Dr. med. vet. (DVM)
    Equine Hox gene expression profile in cultured nasal and articular chondrocytes

    2010 
    University of Leipzig, Faculty of Veterinary Medicine
    Veterinarian
    Curriculum of Veterinary Medicine

    Recent research activities

    • Conducting preclinical study phase to demonstrate safety and efficacy under GLP conditions in short- and long-term studies in large animals

    Positions and honors

    2023 – date
    Assistant Lecturer in documentation in animal trials (VetSpA), University of Leipzig, Faculty of Veterinary Medicine

    2022 – date
    Assistant Lecturer in exotic species, University of Leipzig, Faculty of Veterinary Medicine

    2020 – date
    Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Study director of the GLP test facility

    2019–2023
    Veterinarian in laboratory animal facility, University of Leipzig, Faculty of Veterinary Medicine

    2018 – date
    Assistant Lecturer in preclinical models, post-gradual M.Sc. program "Clinical research and translational medicine", University of Leipzig, Medical Faculty

    2017 – date
    Fraunhofer Institute for Cell Therapy and Immunology IZI Leipzig

    2014–2017
    Teacher for animal medical assistants and animal care keepers, Sächsische LehmbauGruppe

    2010–2014
    Veterinarian in different veterinary practices in Leipzig

    Publications

Associated staff

Attila Tárnok

Prof. Dr. 
Associated employee Department of Preclinical Development and Validation