Description
Applications
The CliniMACS CD141 (BDCA-3) Product Line was developed for enrichment of CD141 (BDCA-3)+ dendritic cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System.
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”.
Overview
The CD141 (BDCA-3) antigen is expressed at high levels on a minor subpopulation (about 0.02% of blood leukocytes) of human myeloid/conventional dendritic cells (cDCs).
CD141 (BDCA 3)-high blood cDCs are CD11c-dim, CD123–, CD4+, Lin–, CD45RO+, CD2–, and CD16– and express myeloid lineage markers. This population has been designated as type-1 cDCs (cDC1) and has distinct markers from the CD1c (BDCA-1)+ blood DCs population (designated cDC2).
Indeed, unlike CD1c (BDCA-1)+ cDC2, CD141 (BDCA-3)-high cDC1 lack expression of CD2 and Fc receptors such as CD32, CD64, or FcεRI. Furthermore, cDC1 differ from cDC2 in terms of Toll-like receptor expression.
CD141 (BDCA-3) is also present at very low levels on CD14+ monocytes, granulocytes, CD303 (BDCA 2)+ CD304 (BDCA-4/Neuropilin-1)+ plasmacytoid DCs and CD1c (BDCA-1)+ cDCs. CD141 is also known as thrombomodulin and mediates co-agglutination by interaction with thrombin and protein C, though nothing is known about its function on dendritic cells.
CD141+ cDCs are specialized in detection and uptake of necrotic cell debris of virally infected cells or tumor cells and cross-presentation of derived-antigens to CD8+ T cells. In addition they are able to secrete IFNλ, important in the development of an immune response.
The CliniMACS® CD141 (BDCA 1) Product Line consists of murine CD141 (BDCA 3) monoclonal antibodies conjugated to superparamagnetic iron dextran particles. One vial contains 7.5mL sterile, non pyrogenic solution. The performance of the CliniMACS CD141 (BDCA 3) Product Line depends on the individual separation strategy. For information on respective capacities, refer to the CliniMACS User Manual or contact your local representative. Please inquire about required CliniMACS System components and accessories.
