Flexible strategies for closed system Treg cell enrichment and isolation. Our automated manufacturing processes on the CliniMACS Prodigy® and CliniMACS® Plus expand your possibilities.
Regulatory T (Treg) cells are a specialized subpopulation of T cells that act to suppress immune responses, thereby maintaining homeostasis and self-tolerance. Their unique function has made them an interesting target cell population for immunotherapy in a number of different indications, including prevention and treatment of graft-versus-host disease (GvHD) after haploid stem cell transplantation (HSCT)1-4, suppression of solid organ rejection after transplantation5-9, and treatment of autoimmune diseases like type 1 diabetes10,11.
To address the variety of Treg cell applications, Miltenyi Biotec provides a broad range of tools for clinical use. By combining the CliniMACS Cell Manufacturing Platform with MACS GMP Products and our GMP-compliant cell sorter MACSQuant® Tyto®, you can now significantly enhance your clinical-grade Treg cell manufacturing possibilities.
The clinical-grade Treg cell manufacturing process consists of three steps, in which Treg cell isolation counts as the most challenging. To meet the need of GMP-compliance, automation, scalability, and customizable cell manufacturing, we provide two approaches for isolation of regulatory T cells. Furthermore we offer unique and comprehensive solutions for Treg cell activation, cultivation, and analysis.
Isolation of polyclonal Treg cells
Cell separation on the CliniMACS Plus Instrument is an easy and GMP-compliant method to magnetically isolate your CD25high Treg cells, with or without prior depletion of CD8 or CD19 cells with a high purity and recovery.
Advantages of this method:
With Treg cells being more and more used as treatment options to suppress solid organ rejection after transplantation, for autoimmune diseases, and as CAR Treg cells, the demand for ultra-pure antigen-specific Tregs has recently increased tremendously.
Miltenyi Biotec now offers solutions to meet the needs of the field. The combination of the CliniMACS Prodigy for pre-enrichment and the MACSQuant Tyto Cell Sorter for subsequent high-purity cell sorting guarantees full sterility of your medical product.
Automated cell separation and sorting
Isolation of a ultra-pure Treg cell subpopulation using the CliniMACS Prodigy LP-25 Pre-enrichment Process and the MACSQuant Tyto Cell Sorter.
Advantages of this method:
In order to improve the purity and quantity of clinical-grade Treg cells, we offer GMP-compatible expansion products. Ideal cultivation and expansion of Treg cells rely on the strong synergy of:
The MACS GMP ExpAct Treg Kit has been designed to efficiently expand Treg cells after a CliniMACS CD25 enrichment procedure while maintaining FoxP3 expression. It can be used in combination with TexMACS GMP Medium and MACS GMP Rapamycin, which inhibits the expansion of conventional T cells and thereby enhances the proportion of expanded Treg cells in culture.
Henrieta Fazekasova, Sarah Thirkell, Katie Lowe, Andrew Bushell, and Giovanna Lombardi, Immunoregulation laboratory, MRC Centre for Transplantation, King’s College London, Guy’s Hospital, London, UK
Profit from MACS GMP Rapamycin to enhance the proportion of FoxP3+ Treg cells and to inhibit the expansion of conventional T cells during the cultivation and expansion step12. We offer 100 nM ready-to-use MACS GMP Rapamycin to improve your culturing.
To enhance your Treg cell culturing, we offer TexMACS GMP medium which is specifically developed for T cell cultivation. TexMACS GMP medium is serum- and xeno-component free, but it is supplemented with pharmaceutical-grade human serum albumin. To support you with the consistently high standards, a QC functionality test is done on every batch.
Our MACS GMP Cytokines are designed according to the recommendations of <USP 1043> on ancillary materials and manufactured and tested under a certified ISO 13485 quality system. In addition, we provide you with a lot-to-lot consistency and lot-specific certificates of analysis.
The Treg Suppression Inspector has been developed for the in vitro functional characterization of human CD4+ CD25+ regulatory T cells.
Our Treg Detection Kits are optimized antibody kits with pre-titrated antibodies that ensure a reliable flow cytometric analysis of Treg cells. The kits are ready-to-use cocktails, which conveniently reduce pipetting steps.
REAfinity Antibodies are recombinant antibodies that provide superior lot-to-lot consistency and purity compared to mouse or rat hybridoma-derived, monoclonal antibodies. They have been recombinantly engineered to produce highly specific antibodies that require no FcR blocking step. Additionally, they all have the same IgG1 isotype, requiring less isotype controls.
Treg characterization with REAfinity Antibodies
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