CELL AND TISSUE ENGINEERING
FACILITY – cGMP

When cells heal

doc. RNDr. Irena Koutná, Ph.D.

  • CAR-T lymphocytes in the treatment of cancer.
  • Virus-specific lymphocytes in the treatment of post-transplant infections.
  • Determination of cellular immunity after undergoing COVID-19.

Research focus
The CTEF-cGMP facility represents a unit for Cell-based Medicinal Products (CBMPs) or Advanced The­rapy Products (ATPs) including cell therapy and tissue engineered products. These products are manu­factured from viable autologous, allogeneic or xenogeneic cells and they can also contain non-cellular components (chemical/biological compounds, matrices, scaffold etc.). All manufacturing and production control activities in CTEF are carried out in accordance with the principles of cGMP quality. This is in order to provide the authorization for the manufacturing of investigation of all medical products within the cli­nical trials. Environmental Monitoring and Assessment is conducted continuously during the production processes.

Research objectives

• Development of clinical-scale manufacturing processes based on cell and tissue engineering.

• Development of analytical methods for product characterization and release.

• GMP manufacturing and quality control of releasing clinical–grade products.

Main partners

• Institute of Hematology and Blood Transfusion, Praha, Czech Republic

• Masarykova Univerzita, Brno, Czech Republic

• The Institute of Genetic Medicine, Newcastle, United Kingdom

Offered services and expertise

• The facility provides licensed manufacturing and testing of cGMP grade cell-based medical products for pre-clinical and clinical trials and is available to scientists in the academic and private sector.

• Taking care of project licenses and authorization processes.

Top publications

  • 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):5366REHAKOVA 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.