The CliniMACS Prodigy® Tumor Reactive T Cell (TRT) Process offers a new, adaptable platform for scientists and clinicians working on tumor-infiltrating lymphocyte (TIL) therapy, and can be tailored to the individual user’s desired indication and methodology. With our TRT process, it is possible to stimulate and isolate tumor-reactive T cells and then expand them in a closed, automated, GMP-compliant system in as little as two weeks.
Furthermore, specific tumor-reactive T cell populations can also be isolated with GMP-compliant cell sorting using the MACSQuant® Tyto® Cell Sorter. Discover how our technologies finally allow the realization of easy, safe, and effective personalized T cell medicines.
The CliniMACS Prodigy Platform covers the entire workflow for the manufacture of tumor-reactive T cells: T cell stimulation, selection (by CD137 activation marker), activation, and expansion. All cell processing steps are automated to ensure a highly reproducible and standardized manufacturing process and include an optional viral transduction. The TRT standard process offers a high level of flexibility:
Cell stimulation can be performed either manually, before connecting your starting material to the CliniMACS Prodigy, or automatically as the first step of the automated CliniMACS Prodigy TRT Process. If there is no need for activation at all, this step can be skipped.
Cells can be stimulated within the tumor digest by the tumor cells that are present in the mixture and/or by the addition of peptides of interest (e.g., MACS® GMP PepTivators® or predicted neo-antigens). Furthermore, cytokines such as MACS GMP Recombinant Human IL-7 and/or IL-15 can be added.
Cell separation on the CliniMACS Prodigy is a simple and easy method for magnetically isolating T cells with a high purity. Advantages of this completely automated method include:
MACS GMP CD3 pure and irradiated feeder cells are required for the activation and expansion of tumor-reactive T cells in the CliniMACS Prodigy TRT Process. Leukapheresis (allogeneic or autologous) or PBMCs can serve as source of feeder cells. These cells must be irradiated to prevent outgrowth during the expansion.
Viral transduction of the cells is possible via an optional transduction step. To achieve long-term gene expression through stable genomic insertion, two types of gene transduction tools are commonly used: gamma-retroviral vectors (RV) or lentiviral vectors (LV). The CliniMACS Prodigy TRT Process supports the use of both vectors.
Vectofusin-1 is compatible with both static and spiculation protocols. We also deliver tailored lentiviral solutions and advanced design and technology that meets global GMP requirements.
Cell expansion takes place in the cell cultivation chamber within the CliniMACS Prodigy Tubing Set. As part of the TRT process activity matrix, culture duration, medium supply, exchange rates, and further parameters are customizable.
Ideal cultivation and expansion of transduced T cells relies on the strong synergy of MACS GMP CD3 pure, TexMACS™ GMP Medium, and MACS GMP Cytokines.
To sort the antigen-specific tumor-reactive T cells from TILs, we provide the revolutionary MACSQuant Tyto Cell Sorter. Our patented microchip-based technology opens new possibilities in basic research and medical applications. Using an integrated, optimized workflow, the MACSQuant Tyto Cell Sorter can sort defined antigen-specific tumor-reactive T cell populations, which can then be expanded afterwards using the previously described CliniMACS Prodigy TRT Process on the CliniMACS Prodigy.
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GMP-compliant flow cytometric cell sorting of antigen-specific T cells using MACS GMP CD8-APC and MACS GMP CD137-PE Fluorescent Antibodies on the MACSQuant Tyto Cell Sorter.
In-process control and quality control (IPC/QC) are required for consistent cell therapy manufacturing. Integrated sampling pouches on the CliniMACS Tubing Sets allow for controls to be collected at any time during the CliniMACS Prodigy TRT Process. With the MACSQuant Instruments and the MACS Flow Cytometry portfolio, including instruments, antibodies, optimized multicolor flow cytometry panels, flow kits, and protocols Miltenyi Biotec provides everything for a reliable and standardized IPC/QC of the clinical process.
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