Research focus

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, to provide the authorization for the manufacture of investigation 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 characterizationand release
  • GMP manufacturing andquality control of releasing clinical–gradeproducts

Main partners

  • Institute of Hematology and BloodTransfusion, Praha, Czech Republic
  • MasarykovaUniverzita, Brno, Czech Republic
  • The Institute of Genetic Medicine, Newcastle, United Kingdom

Technological equipment

  • 4 clean room unitsgrade A inside grade B rooms and multifunctional C grade laboratory
  • Independent systems for cell expansion: CliniMACS Prodigy® System;  Terumo Quantum® Cell  Expansion System
  • Cryobank
  • Independent Quality Control Unit

Offered services and expertise

  • The facility provideslicensedmanufacturing and testing of cGMP grade cell-based medical products for pre-clinical and clinical trialsand is available to academic and private sector scientists.
  • Take care of the project license and authorization process.

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):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.

Team members

  • doc. RNDr. Irena Koutná, Ph.D.
  • Mgr. Ondřej Hobza
  • MVDr. Ludmila Nováková
  • Mgr. Šimon Farkaš
  • Mgr. Jitka Glossová
  • Mgr. Viktor Lukjanov
  • MUDr. Leona Mejzlíková
  • Mgr. Matej Nociar
  • RNDr. Daniela Řeháková
  • doc. MUDr. Filip Růžička, Ph.D.
  • Mgr. Pavel Šimara, Ph.D.
  • Mgr. Tereza Souralová
  • Mgr. Veronika Svačinová, Ph.D.
  • Mgr. Ivana Ťapuchová
  • Mgr. Lenka Tesařová, Ph.D.
  • Ing. Marie Vávrová

Principal Investigator

doc. RNDr. Irena Koutná, Ph.D.
doc. RNDr. Irena Koutná, Ph.D.
Head of CF
Phone: +420 54 318 5571