The process according to claim 1, wherein genetic modification comprises introducing into the activated T cells, T cell subsets and/or T cell progenitors a polynucleotide sequence encoding a chimeric antigen receptor (CAR) or a T cell receptor (TCR).ĥ. The process according to claim 1, wherein activation is performed using high T cell, T cell subsets and/or T cell progenitor densities from between 4e 6 cells/mL to 1e 7 cells/mL during activation.Ĥ. The process according to claim 1, wherein activation is performed using T cell, T cell subsets and/or T cell progenitor densities from between 0.5e 6 cells/mL to 4e 6 cells/mL during activation.ģ. A process for generation of genetically modified T cells, T cell subsets and/or T cell progenitors comprising the steps: a) providing a cell sample comprising T cells, T cell subsets and/or T cell progenitors b) preparation of the cell sample by centrifugation c) magnetic separation of the T cells, T cell subsets and/or T cell progenitors, to thereby provide enriched T cells, T cell subsets and/or T cell progenitors d) activation of the enriched T cells, T cell subsets and/or T cell progenitors using modulatory agents, to thereby provide activated T cells, T cell subsets and/or T cell progenitors e) genetic modification of the activated T cells, T cell subsets and/or T cell progenitors, to thereby provide genetically modified T cells, T cell subsets and/or T cell progenitors and f) expansion of the genetically modified T cells, T cell subsets and/or T cell progenitors in a cultivation chamber, to thereby provide cultured T cells, T cell subsets and/or T cell progenitors and g) washing of the cultured T cells, T cell subsets and/or T cell progenitors, characterized in that all steps are performed within a closed and sterile cell culture system, and wherein expansion step (f) is performed under shaking conditions.Ģ. Ma et al., “Cell density plays a critical role in ex vivo expansion of T cells for adoptive immunotherapy”, J. Wang et al., “Phenotypic and Functional Attributes of Lentivirus-modified CD19-specific Human CD8+ Central Memory Central Memory T Cells Manufactured at Clinical Scale”, Journal of Immunotherapy, Nov. Wang et al., “Manufacture of tumor-and virus-specific T lymphocytes for adoptive cell therapies”, Cancer Gene Therapy Mar. Tumaini et al., “Simplified process for the production of anti-CD19-CAR engineered T cells”, Cytotherapy, Nov. Lymphocytes”, Journal of Hematotherapy Jun. Robinet et al., “A Closed Culture System for the Ex Vivo Transduction and Expansion of Human T. Kaiser et al., “Towards a commercial process for the manufacture of genetically modified T cells for therapy”, Cancer Gene Therapy, Mar. ![]() International Search Report and Written Opinion issued in PCT/EP2015/058817, dated Sep. Hong Zhan et al., “Production and First-In-Man Use of T Cells Engineered to Express a HSVTK-CD34 Sort Suicide Gene”, PLoS One Oct. ![]() 20-24.Īpel et al., “Integrated Clinical Scale Manufacturing System for Cellular Products Derived by Magnetic Cell Separation, Centrifugation and Cell Culture”, Chemie Ingenieur Technik, 2013, 85(1-2):103-110, XP055211907. et al., “Enrichment, stimulation, and viral trasnduction of naive and central memory CD8+ T cells under GMP conditions for translational research towards the development of adoptive cell therapy of cancer patients”, MACS&more, Feb.
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