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Cryopreservation Methods in Manufacturing of Advanced Therapy Medicinal Products
 Jandová, Miroslava ; Čížková, Dana (advisor) ; Stříbrná, Lucie (referee) ; Dubový, Petr (referee)
This dissertation deals with application of cryopreservation methods in the production and transport of advanced therapy medicinal products (ATMPs), including temporary storage in the Hospital cryostorage facility prior its clinical use. This work kept a strict adherence to European Union regulations and harmonized national legal norms. The first section shows the method validation regarding the collection and cryopreservation of starting material - peripheral blood mononuclear cells for the production of registered ATMPs using chimeric antigen receptor of T-lymphocytes (CAR-T). As a practical output from this endeavor, we obtained the approval for the collection, processing, and distribution of mononuclear cells for ATMP manufacture, as well as an export license to foreign facilities where the final production of genetically modified ATMPs takes place. The second part of this work presents the results of collection of starting material for ATMP production - bone marrow for manufacturing of human mesenchymal stromal cells (hMSCs)-based investigational ATMP and explains the development of the cryopreservation protocol for this investigational product under the conditions of good manufacturing practice (GMP) as an experimental part of the clinical trial EUDRA CT No. 2016-000926-21. The protocol was...
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