doc. MUDr. Barbora Weinbergerová, Ph.D.
odborný konzultant
Cell and Tissue Engineering – CTEF
When cells heal
Irena Koutná’s main field of expertise is cell therapy and regenerative medicine. In addition to leading her own research group at the International Clinical Research Center (ICRC), a joint workplace of St. Anne’s University Hospital in Brno and the Faculty of Medicine of Masaryk University, she also lectures at the Department of Histology and Embryology at the Faculty of Medicine, Masaryk University. In the spring of 2020, together with her team, she introduced a methodology for testing memory immunity after COVID-19, tracking how the memory response evolved and declined over the long term following the illness. They also studied the development of memory immunity.
Currently leads / contributes to interdisciplinary projects bridging molecular biology, imaging, and patient care at St. Anne's University Hospital Brno.
Research Group
- Team size
- Team size: 17 Researchers
- Place
- Place: Building B1, 5th Floor
- Collaborates with
- Collaborates with Charles University, Prague
Head of Research Group
- doc. RNDr. Irena Koutná, Ph.D.
Members
Mgr. Jindřich Beránek
Lab Manager
Ing. Petra Česnek, Ph.D.
Lab Manager
RNDr. Daniela Hulínová
Production Manager
Mgr. Barbora Frimlová
Laboratory Technician Specialist
Mgr. Katarína Streďanská
Laboratory Technician Specialist
Mgr. Milan Hluchý, Ph.D.
Laboratory Technician Specialist
Mgr. Anna Macečková Brymová, Ph.D.
Laboratory Technician Specialist
Ing. Lucie Toufarová, Ph.D.
Laboratory Technician Specialist
Mgr. Eva Vaňharová
Laboratory Technician Specialist
RNDr. Lucie Kulišťáková
Laboratory Technician Specialist
Ing. Marie Vávrová
Kvalifikovaná osoba
Ing. Jana Šplíchalová, Ph.D.
Kvalifikovaná osoba
Mgr. Tereza Souralová, Ph.D.
Implementation Science Manager
doc. RNDr. Irena Koutná, Ph.D.
Head of CTEF
Mgr. Ivana Ťapuchová
Quality Control Manager
Mgr. Eliška Buštíková
Laboratory Technician
Team Assistant
Mgr. Jindřich Beránek
Administrative Support
Main Objectives
- Development of clinical-scale manufacturing processes based on cell and tissue engineering
- Development of analytical methods for product characterization and release
- GMP manufacturing, quality control and releasing clinical–grade products
- Compliance with ISO 9001 and GMP
Research focus
CTEF represents a unit manufacturing advanced therapy medicinal products (ATMPs) including cell therapy and tissue engineered products. Products are manufactured from viable autologous or allogeneic cells and they can also contain non cellular components (chemical/biological compounds, matrices, scaffold etc.). All manufacturing and quality control activities at CTEF are carried out in accordance with the principles of cGMP to provide the authorization for the manufacture and investigation of all medical products within the clinical trials. Environmental Monitoring and Assessment is conducted continuously during the production processes.
The facility provides licensed manufacturing and testing of cGMP grade medicinal products for pre-clinical and clinical trials and is available to academic and private sector scientists, taking care of the project license and authorization process. In cooperation with Masaryk University, CTEF also provides support in the translation of research and development outcomes into a manufacturing setting.
CTEF has ISO 9001 certification (quality management system) and GMP manufacture permit from SÚKL.
Specific products: Virus-specific lymphocytes (VSL), peripheral blood mononuclear cells (PBMC), chimeric antigen receptor T-cells (CAR-T cells), human embryonic stem cells (hESC), human induced pluripotent stem cells (hiPSC)
The facility cooperates with many partners, including: Masaryk University, Brno, University Hospital Brno; Olomouc University Hospital; Institute of Hematology and Blood Transfusion, Prague; The Institute of Genetic Medicine, Newcastle, UK; Mayo – Center for Regenerative Medicine, Rochester, USA; Leibniz Research Laboratories for Biotechnology and Artificial Organs, Hannover, Germany
Technological equipment
- 3 clean room units grade A inside grade B, Isolator grade A inside grade C room and multifunctional C grade laboratory
- Independent systems for cell expansion: CliniMACS Prodigy® System; Terumo Quantum® Cell Expansion System
- Independent Quality Control Unit
- Controlled Cryobank
Selected Results
- ŤAPUCHOVÁ, Ivana, Robert PYTLIK, Pavel ŠIMARA, Lenka TESAŘOVÁ a Irena KOUTNÁ. Cytomegalovirus and other herpesviruses after hematopoietic cell and solid organ transplantation: From antiviral drugs to virus-specific T cells. Transplant Immunology. Amsterdam: Elsevier B.V., 2022, roč. 71, April, s. 1-13. ISSN 0966-3274. doi:10.1016/j.trim.2022.101539.
- SOURALOVÁ, Tereza, Daniela ŘEHÁKOVÁ, Lenka TESAŘOVÁ, Aleš HAMPL a Irena KOUTNÁ. Characterization of Clinical-Grade Stem Cells: Microscopic, Cellular, Molecular, and Functional Characterization of Stem Cells and Their Products According to Regulatory Requirements for FDA Approval. In Stem Cell Production. Singapore: Springer, Singapore, 2022. s. 185-203, 18 s. ISBN 978-981-16-7588-1. doi:10.1007/978-981-16-7589-8_8
- LUKJANOV, Viktor, Irena KOUTNÁ a Pavel ŠIMARA. CAR T-Cell Production Using Nonviral Approaches. Journal of Immunology Research. London: Hindawi, 2021, roč. 2021, Mar 27, s. 1-9. ISSN 2314-8861. doi:10.1155/2021/6644685.
- ŘEHÁKOVÁ, Daniela, Tereza SOURALOVÁ a Irena KOUTNÁ. Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy. International Journal of Molecular Sciences. Basel: MDPI, 2020, roč. 21, č. 7, s. 1-14. ISSN 1422-0067. doi:10.3390/ijms21072435.
- FARKAS S, SIMARA P, REHAKOVA D, VEVERKOVA L, KOUTNA I. Endothelial Progenitor Cells Produced From Human Pluripotent Stem Cells by a Synergistic Combination of Cytokines, Small Compounds, and Serum-Free Medium. Front Cell Dev Biol. 2020 May
- TESAROVA L, JARESOVA K, SIMARA P, KOUTNA I. Umbilical Cord-Derived Mesenchymal Stem Cells Are Able to Use bFGF Treatment and Represent a Superb Tool for Immunosuppressive Clinical Applications. Int J Mol Sci. 2020 Jul 28;21(15):5366
- REHAKOVA D, SOURALOVA T, KOUTNA I. Clinical-Grade Human Pluripotent Stem Cells for Cell Therapy: Characterization Strategy. Int J Mol Sci. 2020 Mar 31;21(7):243
- TESAROVA, L., SIMARA, P., STEJSKAL, S., KOUTNA, I.The Aberrant DNA Methylation Profile of Human Induced Pluripotent Stem Cells Is Connected to the Reprogramming Process and Is Normalized During In Vitro Culture.PLoS One. 2016, 11(6), e0157974.
- STEJSKAL, S., STEPKA, K., TESAROVA, L., STEJSKAL, K., MATEJKOVA, M., SIMARA, P., ZDRAHAL, Z., KOUTNA, I. Cell cycle-dependent changes in H3K56ac in human cells. Cell Cycle. 2015, 14(24), 3851-63.
- TESAROVA, L., STEJSKAL, S., KOUTNA, I.Driven hematopoietic differentiation of embryonic stem cells: epigenetic perspectives. CurrentPharmaceutical Design. 2014, 20(11), 1674-86.
The CTEF department consists of two teams:
- The Center for Cell and Tissue Engineering, St. Anne’s University Hospital in Brno (CTEF-FNUSA) – production in GMP quality.
- The Center for Cell and Tissue Engineering, Masaryk University (CTE-MUNI) – research division.
The Cell and Tissue Engineering Center of St. Anne’s University Hospital Brno (CTEF-FNUSA) is a specialized team of experts focused on the manufacturing and quality control of medicinal products for advanced therapies, including cell and gene therapy.
CTEF is certified for Good Manufacturing Practice (GMP), allowing the production of medicinal products as well as advanced therapy medicinal products (ATMPs), and also complies with ISO 9001 standards.
Our Goals
- Collaborating with doctors to advance modern medicine and thus help patients
- Developing procedures for the production of cell and tissue preparations for preclinical and clinical applications
- Establishing procedures for thorough characterization and product release using analytical methods
- Manufacturing and quality control of products in accordance with GMP (Good Manufacturing Practice) and their release
- Pushing the boundaries of personalized medicine in the Czech Republic
- Keeping pace with global trends in cell and gene therapies
- Ensuring the competitiveness of the Czech Republic in the global production of cellular products
Collaboration
