Chimeric antigen receptor (CAR) T cell therapy is undoubtedly leading a revolution in cancer therapy.1 Recent successes in treating hematologic malignancies with CAR T cell therapy and the availability of several commercial products have prompted increased interest in cancer immunotherapy.2 These advances have also opened new lines of research looking to optimize the safety and efficacy of CAR T cell therapies via complex gene engineering3 and promising developments like engineered T cell receptors (TCRs).4 More recently, genetically engineered T cells are also being applied in other indication areas like solid tumors, infectious diseases, and autoimmunity.5-7
Currently, CAR T cell and TCR T cell production consists of various complex process steps. GMP cell manufacturing is labor intensive, and as such, represents a significant challenge in further development of gene-modified T cell therapies. The CliniMACS Prodigy T Cell Transduction (TCT) and CliniMACS Prodigy T Cell Transduction – Large-Scale (TCT-LS) provide a unique all-in-one solution to this challenge. Well-established and widely used in clinical settings8–12, the CliniMACS Prodigy Platform generates gene-modified T cells via viral transduction in a standardized and automated process.13 The closed system is a breakthrough in cell manufacturing designed to facilitate the transition of novel strategies like TCR T cell therapies to clinical use.4
The CliniMACS® Electroporator expands the cell processing capabilities of the CliniMACS Prodigy Platform to include non-viral gene-engineering in a closed and automated fashion. Electroporation parameters are flexibly adaptable to optimize transfection protocols for different gene-engineering technologies, such as TALENs, CRISPR/Cas, zinc finger nucleases, the Sleeping Beauty transposon system, siRNA, and more. The CliniMACS Prodigy T Cell Engineering (TCE) enables complex T cell engineering via electroporation and/or viral transduction, leading the way in GMP-compliant gene engineering.14–16
|CliniMACS Prodigy T Cell Transduction (TCT)||CliniMACS Prodigy T Cell Transduction Large-Scale (TCT-LS)||CliniMACS Prodigy T Cell Engineering (TCE)|
|Main application||CAR T cell manufacturing||TCR T cell manufacturing||Complex engineered T Cell manufacturing|
|General features||T cell isolation, activation, viral transduction, expansion, rebuffering, and harvest||T cell isolation, activation, viral transduction, expansion, rebuffering, and harvest||T cell isolation, activation, viral transduction and/or electroporation, expansion, rebuffering, and harvest|
|Starting material||Heterogenous blood products like whole blood, buffy coat, leukapheresis||Fresh or frozen leukapheresis||Heterogenous blood products like whole blood, buffy coat, leukapheresis|
|Gene engineering method||Viral transduction (lentivirus or retrovirus)||Viral transduction (lentivirus or retrovirus)||Electroporation and/or viral transduction (lentivirus or retrovirus)|
|Culture capacity (volume)||250 mL||600 mL||250 mL|
|Number of harvested T cells||~5x109||~2x1010||Electroporation included: ~2x109|
No electroporation: ~5x109
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