![]() ![]() 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. The flexibility and ease-of-use associated with this device and the developed process for clinical scale production of engineered T cells creates a solution for the treatment of large patient groups and facilitates economic commercial-scale manufacturing.Casati, A. Clinically relevant numbers of functional gene-modified T cells (>10 9) have been generated within 10-14 days using the automated manufacturing process. The reagent is biodegradable, sterile filtered, and suitable for potent T cell activation, gene-modification, and expansion. TransAct is a colloidal reagent developed for polyclonal T cell stimulation that is soluble and can be removed by washing. Within the process a novel stimulatory reagent has been implemented: MACS GMP TransAct™ in combination with TexMACS GMP Medium. Starting from leukapheresis or whole blood products, the automated process enables magnetic labeling and enrichment of T cells, their subsequent stimulation, gene-modification with lentiviral vectors, expansion and final formulation with minimal user interaction. In order to face these challenges, Miltenyi Biotec has dedicated large efforts to further enable automation of cell manufacturing by developing a unique cell processing platform, the CliniMACS ® Prodigy, which enables the automated manufacturing of clinical grade gene-modified T cells in a closed single-use tubing set. Moreover, the cell-manufacturing process requires extensive training of personnel as well as a dedicated infrastructure, which restricts these clinical procedures to very few institutions worldwide. However, such personalized medicine faces several challenges in the complexity associated with the current clinical manufacturing methods, which hampers dissemination.Ĭonventionally, the preparation of autologous gene-modified T cells comprises many (open) handling steps, is labor intensive and is not adapted to treat large numbers of patients or for commercial manufacturing. Adoptive immunotherapy using gene-modified T cells redirected against cancer has proven clinical efficacy and tremendous potential in several medical fields. ![]()
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