ACIU represents excellent non-commercial production unit approved by National Regulatory Agency for development and production of advanced therapy medicinal products (ATMP) including dendritic cells (DB), activated expanded lymphocytes (AEL), and mesenchymal stromal cells (MSC).
All manufacturing and production-control activities in ACIU are carried out in accordance with the principles of Good Manufacturing Practice (GMP Quality), to the extent of the authorization for the manufacturer of investigational medicinal products within the clinical trial. This GMP Unit is a unique facility within the academic sector, and the cooperation with LRI CZECRIN allows to improve the effective translation of academic discoveries to further clinical investigation steps.
ACIU currently manufacture two ATMP products
MyDendrixTM - a somatic cell therapy medicinal product from autologous dendritic cells, which is being investigated in a clinical trial “Combined antitumor therapy with ex vivo manipulated interleukin-12 producing dendritic cells in pediatric, adolescent and young adult patients with progressive, relapsing or primarily metastatic high-risk malignancies” (EudraCT No. 2014-003388-39) at the Department of Pediatric Oncology, University Hospital Brno.
FlyCellixTM - Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells, developed in ACIU for patients with Epidermolysis Bullosa, rare disease with unmet medical need. FlyCellix is currently investigated in Phase I clinical trials “Safety and efficacy of Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells in patients with Epidermolysis Bullosa: Clincial Trial Phase I/II” (EudraCT No. 2020-002936-55).
The ACIU team consists of experts with experience in pharmaceutical manufacture, with expertise in cell biology and immunology, and/or in diagnostic methods.
Head of the ACIU
Prof. Dalibor Valik, MD, PhD. DABCC
Head of Quality Control (QC)
Assoc. Prof. Lenka Zdrazilova Dubska, Ph.D.
Head of GMP production unit
Katerina Pilatova, MSc., Ph.D
Qualified Person (QP)
Lucie Flajsarova, Ing.
In collaboration with Department of Pediatric Oncology, University Hospital Brno, Transfusion department, University Hospital Brno, Internal hematology and oncology clinic, University Hospital Brno, Department of Pediatric Dermatology, Children's Hospital, University Hospital Brno, Clinic of burns and reconstructive surgery, University Hospital Brno, Faculty of Science, Humanities and Education, Technical University Liberec, Department of Chemistry, section Bioengineering
