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Gibco™ CTS™ Dynabeads™ Treg Xpander

Catalog No. 46000D
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Catalog No. 46000D Supplier Gibco™ Supplier No. 46000D

Please call Customer Service at 1-800-234-7437 or send an email to help@thermofisher.com for assistance.

Description

Optimized for the ex vivo activation and expansion of regulatory T cells (Tregs), CTS Dynabeads Treg Xpander provides more specific and higher fold expansion compared to our CTS Dynabeads CD3/CD28.

Optimized for the ex vivo activation and expansion of regulatory T cells (Tregs), CTS Dynabeads Treg Xpander provides more specific and higher fold expansion compared to our CTS Dynabeads CD3/CD28. Tregs activated and expanded with this product show suppressive activity and display the characteristic Treg cytokine profile and phenotype. Furthermore, high stability of the expanded Tregs has been demonstrated through analysis of the Treg-specific demethylated region.

CTS Dynabeads Treg Xpander features include:

  • Aseptically manufactured and ready for clinical trials and cell therapy manufacturing process development
  • Drug Master File (DMF) to cross-reference in IND applications
  • >800 fold expansion after two stimulations
  • Treg phenotype (FOXP3) and suppressive function maintained

Regulatory T cells (CD4+ CD25+ FOXP3+) are a suppressive subset of CD4+ T helper cells and are important for the regulation of immune responses. Due to a relative frequency of 1–2% of the total lymphocyte population, ex vivo expansion of Tregs prior to adoptive transfer is expected for most clinical applications.

Specifications

Cell Type T Cells (Regulatory)
Content And Storage 10 mL CTS Dynabeads Treg Xpander, 2x108 beads/mL, store at 2–8°C
Product Type Treg Expander
Product Line Dynabeads
Quantity 1 Vial
Shipping Condition Wet Ice
Target Species Human

Frequently Asked Questions (FAQs)

What is the definition of superparamagnetic, and what does this mean for my cell isolation application with Dynabeads magnetic beads?

Superparamagnetic means that the Dynabeads magnetic beads exhibit magnetic properties when placed within a magnetic field, but have no residual magnetism when removed from the magnetic field.

This means that your targeted cells, proteins, or nucleic acids are only subjected to magnetic forces during the time the beads are on the magnet. The beads do not aggregate, but remain evenly dispersed in suspension.
What is CTS?

The Gibco Cell Therapy Systems (CTS) portfolio of cell and gene therapy products are GMP manufactured, safety tested, and backed by regulatory documentation to support your transition from discovery through clinical and commercial manufacturing. Through our CTS solutions, we are committed to helping customers streamline therapeutic development, minimize risk, and ease the burden on their quality systems. Learn more here.
Are there potential risks to patient safety when using CTS Dynabeads or CTS Detachable Dynabeads?

Unlike magnetic beads from our competitors, CTS Dynabeads are not phagocytosed by T cells or incorporated into patients. CTS Dynabeads are inert to T cell phagocytosis and can therefore be removed (using the CTS DynaCellect Magnetic Separation System, Cat. No. A55867) before the final drug is injected into the patient.

There is also no evidence that CTS Dynabeads activate T cells non-specifically. Adding Dynabeads without antibodies, for example, to cell suspensions does not upregulate activation markers nor induces expansion.
Are CTS Dynabeads and CTS Detachable Dynabeads for clinical trial and commercial manufacturing use?

Yes, CTS Dynabeads and CTS Detachable Dynabeads are GMP-grade and CTS-branded, which means that they are eligible for use in process development, clinical trials, and commercial manufacturing.

Thermo Fisher Scientific’s Cell Therapy Systems (CTS) translates to cGMP manufacturing, testing, and traceability documentation (such as Drug Master Files and Regulatory Support Files) for customer filing needs, and a proven track record of use in many clinical trials and commercialized drugs on the market.

The CTS Dynabeads portfolio, specifically, has been actively used in over 200 clinical trials in 2023 as well as in a number of FDA-approved drugs for commercial use.
Do the CTS Dynabeads CD3/CD28 (Cat. No. 40203D) and CTS Dynabeads Treg Xpander (Cat. No. 46000D) contain sodium azide?

No, there is no sodium azide in either of CTS Dynabeads CD3/CD28 (Cat. No. 40203D) or CTS Dynabeads Treg Xpander (Cat. No. 46000D).
Are Dynabeads compatible with centrifugation?

Dynabeads are not designed or intended to be used with centrifugation. Pressure from centrifugal forces should not theoretically be a problem for the Dynabeads themselves due to their rigid nature and composition. However, the force exerted by the Dynabeads on surrounding cells within the pellet may be detrimental to cell viability.
What is the level of support offered when using CTS Dynabeads and CTS Detachable Dynabeads in clinical trials and commercial manufacturing?

Our CTS Dynabeads and CTS Detachable Dynabeads are supported with Drug Master Files (DMFs), Regulatory Support Files (RSFs), and other traceability documentation.

We have dedicated resources from our Quality and Regulatory teams to support customers who enter into a Commercial Supply Agreement with us.
What is the difference between CTS Dynabeads Treg Xpander (Cat. No. 46000D) and Dynabeads Human Treg Expander (Cat. No. 11129D)?

CTS Dynabeads Treg Xpander (Cat. No. 46000D) is aseptically manufactured with GMP antibodies and has a Drug Master File (DMF) at regulatory agencies. Customers can request Letter of Authorization to cross reference the DMF for their clinical trial. The intended use is categorized as: For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.

Dynabeads Human Treg Expander (Cat. No. 11129D) is manufactured with other antibodies as a research use only product and has no regulatory documentation. The intended use is categorized as: For Research Use Only. Not for use in diagnostic procedures.

For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.