Project lead Charité:
Amini group - part of the BeCAT AND IMMUNOLOGY PLATFORM AT THE BIH
Amini group is part of the Charité – Universitätsmedizin Berlin, Berlin Center for Advanced Therapies (BeCAT), which represents a crucial institution for the translation of adoptive T-cells to the patient’s bedside. Furthermore, we are part of the Berlin Institute of Health (BIH) at Charité – Universitätsmedizin Berlin, BIH – Center for Regenerative Therapies (BCRT) where we stand in strong cooperation with the in-house GMP facility as well as the platform of Immunology at the Cranach-Haus.
We are an interdisciplinary and cooperative junior group excited to build a new groundwork for patient specific, GMP compliant anti-viral T-cell therapeutics. We have extensive knowledge in the field of adoptive anti-viral T-cell therapy, and we have already generated CMV as well as Sars-Cov-2 specific T-cell products for clinical application.
Photography ©HeidiScherm
Project lead DRFZ:
Mashreghi group - part of the DRFZ
Mashreghi’s research group is specialized in studying cells individually in order to determine which genes and antigens they express, suggesting their role in the immune response. The technological know-how is based on the use of oligonucleotide-coupled antibodies for labelling of surface proteins (CITE-Seq), the generation of 10X Genomics based single cell cDNA libraries (10X Genomics 5`Next GEM) followed by NGS sequencing (Illumina), the analysis of the antigen receptor repertoire (single-cell V(D)J sequencing) of B and T lymphocytes at the single-cell level in the context of their global gene and surface protein signature. The expertise of this research group offers a unique opportunity to study immune responses, in particular currently, in collaboration with virological and clinical research groups.
To drfz website
About the BeCAT
Berlin Center for Advanced Therapies (BeCAT) at Charité - Enabling New Drugs and Innovative Therapeutic Approaches in Regenerative Medicine, Hematology and Oncology. The Berlin Center for Advanced Therapies (BeCAT ) pursues a new research concept for the development and application of advanced therapy medicinal products (ATMPs) in a state-of-the-art research structure at the Charité Campus Virchow-Klinikum. The new building to be constructed for the implementation of the concept is being funded with more than 29,000,000.00 euros pro rata by the Federal Government and the State of Berlin within the framework of the program for research buildings at universities (§ 91b GG).
To Becat website
Professor Reinke is the founding director of the Berlin Center for Advanced Therapies (BeCAT), a member of the founding committee of the BIH Center for Regenerative Therapies (BCRT), head of the Cell Therapy and Personalized Immunosuppression Research Group, and an expert on BeCAT's state-of-the-art GMP (Good Manufacturing Practice) facility.
About the BECAT associated GMP Facility
Advanced therapy medicinal products (ATMPs) are medicinal products for human use. They are no longer synthetic agents for the relief of symptoms, but biological medicines for the restoration of the patient's health. Often referred to as "living medicines," they break with the principles of classical drug development and open up completely new possibilities for the treatment of previously incurable diseases. The Berlin Center for Advanced Therapies (BeCAT) is engaged in the development of ATMPs for diseases with high unmet medical need and holds a manufacturing license for several T-cell products. BeCAT has a state-of-the-art GMP (Good Manufacturing Practice) facility that enables it to manufacture all classes of ATMPs as investigational products, including in combination with biomaterials and with 3D-printed systems.
GMP TEAM BeCAT
Prof. Dr. med. Petra Reinke
Nephrologist, founding director of BeCAT, and qualified person for the GMP facility.
Prof. Dr. med. Petra Reinke
Nephrologist, founding director of BeCAT, and qualified person for the GMP facility.
Photography ©HeidiScherm
Dr. Andy Römhild
Biotechnologist and head of the production unit at the BeCAT GMP facility.
Dr. Andy Römhild
Biotechnologist and head of the production unit at the BeCAT GMP facility.
Photography ©HeidiScherm
Daniel Kaiser
Biotechnologist and Head of Quality Management & Control (QM/QC)
Daniel Kaiser
Biotechnologist and Head of Quality Management & Control (QM/QC)
REGULATORY AFFAIRS TEAM BeCAT
Dr. Leila Amini
Head of the Regulatory Affairs Department and Junior Research Group Leader Process Development.
Dr. Leila Amini
Head of the Regulatory Affairs Department and Junior Research Group Leader Process Development.
Photography ©HeidiScherm
Enrico Fritsche
Biochemist - Regulatory Affairs Unit
Enrico Fritsche
Biochemist - Regulatory Affairs Unit
Dr. Jaspal Kaeda
Molecularbiologist - Regulatory Affairs Unit
Dr. Jaspal Kaeda
Molecularbiologist - Regulatory Affairs Unit
OUR BIH/ChariTé TEAM
Our final clinical virus-specific T cell warriors are characterized in detail so that potential patients can be treated safely and effectively. This is being done in close collaboration with the BIH - Center for Regenerative Therapies (BCRT) Experimental Immunotherapies group and the Tissue Immunology group. We intend to further expand our new and unique platform by incorporating human organ-on-a-chip models to further investigate the effects of our T cell warriors in a 3D organoid approach.
Tissue-Immunology
Prof. Dr. med. Hans-Dieter Volk is Senior Professor at the Institute of Medical Immunology of Charité, member of the founding board as well as long-time Director Emeritus of the BIH Center for Regenerative Therapies (BCRT) and CSO of CheckImmune GmbH. Prof. Dr. med. Hans-Dieter Volks Tissue Immunology Group performs immune monitoring of regenerative therapies and develops biomarkers and matching analyses. It also investigates immune modulation by stem cells in vitro and in vivo. In addition, they analyze the interaction between the immune system and biomaterials in vitro and in vivo.
Experimental Immunotherapy
Dr. Michael Schmück-Henneresse leitet die Plattform Immunologie und Immuntherapien am BIH-Center für Regenerative Therapien (BCRT). Er forscht an T Zell Reaktionen, welche durch Tumore, Pathogene und Autoimmunität entstehen können. Zur Experimentellen Immunologie Website
Prof. Dr. med. Hans-Dieter Volk
Senior professor Institute for Medical Immunology.
Prof. Dr. med. Hans-Dieter Volk
Senior professor Institute for Medical Immunology.
Photography ©HeidiScherm
Dr. Anna-Catharina Michaela Krebs
medical biotechnologist and Postdoc Tissue-Immunology group.
Dr. Anna-Catharina Michaela Krebs
medical biotechnologist and Postdoc Tissue-Immunology group.
Photography ©HeidiScherm
Dr. Michael Schmück-Henneresse
Leader of the platform Immunology and group leader for Experimental Immunotherapy.
Dr. Michael Schmück-Henneresse
Leader of the platform Immunology and group leader for Experimental Immunotherapy.
Photography ©HeidiScherm
Dr. Lukas Ehlen
Anesthesiologist and postdoc in the Experimental Immunotherapy Group
Dr. Lukas Ehlen
Anesthesiologist and postdoc in the Experimental Immunotherapy Group
Photography ©HeidiScherm
OUR Clinical PARTNERs
Dr. med. Mir Timo Zadegh Nazari-Shafti
Cardiac Surgeon, BIH Clinician Scientist, Junior Group Leader Cardiovascular Research
Dr. med. Mir Timo Zadegh Nazari-Shafti
Cardiac Surgeon, BIH Clinician Scientist, Junior Group Leader Cardiovascular Research
Dr. med. Philipp Knape
Cardiac Surgeon and senior physician
Dr. med. Philipp Knape
Cardiac Surgeon and senior physician
About the Amini Group
The Amini group is led by Dr. Leila Amini as principal investigator and head of the regulatory affairs unit at the BeCAT. Furthermore, our young postdoctoral researcher Lisa Burkhardt comes with elaborated background in clinical immunology and drug characterization. We are focusing on the generation of various anti-viral T-cell products (TCPs). Our three doctoral students Ugarit Daher, Niklas Wiese and Ghazaleh Zarrinrad focus on specific generation, investigation, and characterization of TCPs.
All of them work on own research projects concerning either adoptive regulatory T-cells or adoptive anti-viral T-cells with viral specificities such as Influenza, BK-virus, and EBV in various disease contexts and further optimize the clinical application of SARS-CoV-2 and CMV specific T-cells. The Bench to Bedside principle of adoptive anti-viral T-cells is strongly depending on GMP compliant approaches. This is where the expertise of our lab technician Melanie Rothe is focused and where we heavily interact with our cooperation partners from the GMP facility.
Our final clinical virus-specific T-cell warriors undergo in-depth characterization so that potential patients can be treated in a safe and effective way and in this part of the project, we benefit of our cooperation with the Proteomics Core, the Single-Cell-Core as well as the Immune Monitoring group CheckImmune. We envision to elaborate even more on our novel and quite unique platform by including human based organ-on-a-chip models for further assessment of the impact of our T-cell warriors in a 3D organoid approach. This is where we are connected to specialists from the Tissue-Immunology group with strong background on mulit-organ chip based pre-clinical models.
Photography ©HeidiScherm
Our Team
Dr. Leila Amini
Head of Regulatory Affairs Unit and junior group leader process development
Dr. Leila Amini
Head of Regulatory Affairs Unit and junior group leader process development
Head of the Regulatory Affairs Unit at the Berlin Center for Advanced Therapies and junior group leader for “Process Development for Cell and Gene therapy” at the Berlin Institute of Health
- Center for Regenerative Therapies
Scientific career
- Master of Molecular Biomedicine at the University of Bonn and Molecular Medicine at Charité-Universitätsmedizin Berlin. PhD thesis on antiviral T-cell products
- Berlin-Brandenburg Center for Regenerative Therapies of Charité-Universitätsmedizin Berlin
- Background in medical Immunology and T-cell research
Lisa Burkhardt
Postdoctoral researcher
Lisa Burkhardt
Postdoctoral researcher
Postdoctoral researcher supervising research developments in the projects on immunosuppression - resistant regulatory as well as virus-specific T-cells for advanced adoptive T-cell therapy
- Immunology and Adoptive Cell Therapy
Scientific career
- Master of Molecular Biology with main-focus on Immunology. Doctoral thesis on immunological/metabolic Mesenchymal Stem Cells for regeneration at the Berlin Institute of Health – Julius Wolff
- Institute and Center for Regenerative Therapies in Germany
- Background in medical Immunology and T-cell research
Niklas Wiese
Doctoral candidate
Niklas Wiese
Doctoral candidate
Doctoral candidate characterizing immunosuppression-resistant virus-specific and multi-virus-specific T-cell products for advanced adoptive T-cell therapy
- Interface between Immunology and pre-clinical 3D organ-on-a-chip models
Scientific career
- Master of Science in Medical Biotechnology, Technical University, Berlin, Germany
- Master thesis on Tissue regeneration by immunologically primed metabolites at the Berlin Institute of Health – Julius Wolff Institute and Center for Regenerative Therapies in Germany
MSc. Ugarit Daher
Doctoral candidate
MSc. Ugarit Daher
Doctoral candidate
Doctoral candidate characterizing alveolar organoids for pre-clinical testing of Influenza-reactive T-cells for advanced adoptive T-cell therapy
- Interface between pre-clinical Immunology and tissue engineering
Scientific career
- Master of Science in Medical Biotechnology, Technical University, Berlin, Germany
- Master thesis on MLL-rearranged acute leukemia in the Proteomic Hematology
- Lund Stem Cell Center, Lund University in Sweden
Ghazaleh Zarrinrad
Doctoral candidate
Ghazaleh Zarrinrad
Doctoral candidate
Doctoral candidate characterizing immunosuppression-resistant regulatory T-cells for advanced adoptive T-cell therapy
- Immunology and Adoptive Cell Therapy
Scientific career
- Master of Molecular & Cellular Biology, Azad University, Tehran, Iran
- Master thesis on ovarian cancer at the Hematology/oncology and Stem Cell Transplantation Research Center – Shariati Hospital and School of Medicine Teheran in Iran
Melanie Rothe
Technical assistance
Melanie Rothe
Technical assistance
Technical assistance and laboratory representative working on the generation and development of a technology platform for virus-specific T-cell products for advanced adoptive T-cell therapy
- Immunological laboratory underlying GMP compliant manufacturing
Scientific career
- State certified technical assistance for chemical/biological laboratories, Lette Verein, Berlin, Germany
- Strong background in immunology and GMP compliant manufacturing
- DNA-based active substances (purity class C) and investigational drugs (purity class A)
Claudia Beltran-Mestres
Student intern
Claudia Beltran-Mestres
Student intern
Student intern in the research group supporting the establishment of a human pre-clinical lung organoid model for treatment of post-transplant lymphoproliferative disease (PTLD)
- Clinical immunology background
Scientific career
- Master of Science in Advanced Immunology, University of Barcelona/University Autonoma of Barcelona, Barcelona, Spain
- Master thesis on investigating plasma cell pathologies with the focus on multiple myeloma cells, University of Barcelona/University Autonoma of Barcelona, Barcelona, Spain
- ERASMUS exchange student at the Faculty of Science, Universiteit Gent, Gent, Belgium
Photography ©HeidiScherm