CliniMACS® CD3/CD19  Product Line

CliniMACS
®
CD3/CD19 Product Line

The CliniMACS® CD3/CD19 Product Line consists of one reagent containing murine anti-CD3 and one reagent containing murine anti-CD19 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.
Each vial contains 7.5 mL sterile, non- pyrogenic solution.
The performance of the CliniMACS CD3/CD19 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.

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.
CliniMACS GMP MicroBeads are for research use and
ex vivo
cell processing only.
CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.

Applications

The CliniMACS CD3/CD19 Product Line was developed for the simultaneous depletion of unwanted T and B cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System. This approach keeps stem and progenitor cells untouched and leaves immune effector cells, such as NK cells and dendritic cells, in the cellular product.
1,2
  • Selected references

    1. Barfield et al. (2004) A one-step large-scale method for T- and B-cell depletion of mobilized PBSC for allogeneic transplantation. Cytotherapy 6: 1-6
    2. Gordon et al. (2002) A large-scale method for T cell depletion: towards graft engineering of mobilized peripheral blood stem cells. Bone Marrow Transplant. 30: 69-74
  • Selected references

  • Certificates

    Please follow this
    link
    to search for Certificates of Analysis (CoA) by lot number.
Product options: 3
1
kit
EUR 3.960,00 
1
kit
EUR 4.840,00 
1
kit
EUR 8.275,00 

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