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View additional product information for CTS™ Dynabeads™ Treg Xpander - FAQs (46000D)
8 product FAQs found
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.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
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.
Find additional tips, troubleshooting help, and resources within our Cell Culture Support Center.
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.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
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.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
No, there is no sodium azide in either of CTS Dynabeads CD3/CD28 (Cat. No. 40203D) or CTS Dynabeads Treg Xpander (Cat. No. 46000D).
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.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
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.
Find additional tips, troubleshooting help, and resources within our Dynabeads Cell Isolation and Expansion Support Center.
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.