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Dynabeads® CD3/CD28 CTS™ is intended for ex vivo isolation, activation, and expansion of human T-cells in translational research. The technology - previously known as Xcyte™ Dynabeads® or Dynabeads® ClinExVivo™ CD3/CD28 - has been used in a number of clinical studies. By combining anti-CD3 and anti-CD28 antibodies on Dynabeads®, the beads will provide both the primary and co-stimulatory signals that are required for activation and expansion of T cells. Dynabeads® CD3/CD28 CTS™ are manufactured and controlled according to ISO 9001:2000 and ISO 13485:2003 requirements. A Device Master File is held with the FDA for cross-referencing in IND applications, and a CoA is available on request. In the US, Dynabeads® CD3/CD28 CTS™ is available for clinical use only under an approved Investigational New Drug (IND) application. Dynabeads® CD3/CD28 is the research grade version of Dynabeads® CD3/CD28 CTS™. Containing the same amount and ratio of antibodies from the same clones as Dynabeads® CD3/CD28 CTS™, Dynabeads® CD3/CD28 are intended for small scale pre-clinical research.
Applications: The Dynabeads® CD3/CD28 CTS™ technology has been successfully used in ex vivo isolation, activation, and expansion of T-cells in a number of studies, including studies on HIV infection and cancer. Other potential applications for this novel technology includes research into treatment of autoimmune and infectious diseases and prevention of complications associated with chemotherapy and allogeneic stem cell transplantation. In the US, Dynabeads® CD3/CD28 CTS™ is available for clinical use only under an approved IND application.
Legal and regulatory These products may be covered by one or more Limited Use Label Licenses. By use of these products you accept the terms and conditions of all applicable Limited Use Label Licenses. For Research Use or Non-Commercial Manufacturing of Cell-Based Products for Clinical Research. CAUTION: Not intended for direct administration to humans or animals.
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