When cells heal

doc. RNDr. Irena Koutná, Ph.D.

E-mail: irena.koutna@fnusa.cz
Phone: +420 54 318 5571

Key words

Advanced Therapy Medicinal Products, Cell and tissue engineering, GMP-production, Gene therapy.

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

Main goals

  • 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

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