Description
Applications
The CliniMACS Cytokine Capture System (IFN-gamma) – Product Line allows for the concomitant enrichment of viable antigen-specific CD4+ and CD8+ IFN- gamma–secreting T cells.
Referenced literature
Antigen-specific CD4 and CD8 T cells can be enriched using the CliniMACS Cytokine Capture System (IFN-gamma)1.
A successful enrichment of T cells with the specificity for HCMV2, AdV3, EBV4, and Aspergillus5, as well as leukemia-reactive T cells6 has been demonstrated.
Adoptively transferred antigen-specific T cells have been shown to restore protective immunity and control established AdV7, HCMV8, and EBV9 infections after hematopoietic stem cell transplantations.
Disclaimer
The CliniMACS® System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations - e.g., for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device (HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this indication has not been demonstrated. Other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or FDA approval.
CR/GMP products are for ex vivo cell processing only, and are not intended for human in vivo applications. CR/GMP products are designed, manufactured and tested under an ISO 13485 quality management system and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The manufacturing and testing of CR/GMP products of biological origin are in compliance with EP chapter 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”.
In Canada, any clinical application of the output product must be performed in accordance with applicable Canadian legislation and regulations that pertain to cellular therapies (e.g. for advanced cellular therapies, the applicable sections of the Food and Drugs Act and the Food and Drug Regulations).
Overview
Interferon-gamma (IFN-gamma) is a cytokine secreted by CD4+ and CD8+ memory and effector T cells upon antigenic restimulation.
The CliniMACS® Cytokine Capture System (IFN-gamma) – Product Line is comprised of the CliniMACS IFN-gamma Catchmatrix Reagent, consisting of CD45 antibodies conjugated to IFN-gamma specific antibodies, and the CliniMACS IFN-gamma Enrichment Reagent.
The CliniMACS IFN-gamma Enrichment Reagent consists of murine anti- IFN-gamma monoclonal antibodies conjugated to superparamagnetic iron dextran particles. The CliniMACS IFN- gamma Enrichment Reagent allows the magnetic selection of IFN-gamma–secreting cells.
One kit is suitable for processing up to 1 × 109 total cells.
Please inquire about required CliniMACS System components and accessories.
