Gibco™ CTS™ Detachable Dynabeads™ CD3/CD28 Kit

The Gibco CTS Detachable Dynabeads CD3/CD28 Kit is intended for ex vivo isolation and activation of T cells in a simultaneous one-step mechanism. As part of a next-generation platform, this offering is the first cGMP cell selection technology to have an active release mechanism for process development, clinical trial, and commercial manufacturing use.

Features of the CTS Detachable Dynabeads CD3/CD28 Kit include:
• Empowers users with process flexibility by allowing active release of beads from target cells at any time
• Optimizes target cell purity, yield, activation profile, and desired phenotype thanks to the active release mechanism that gives users more control
• Provides an automation-friendly solution by working directly with the CTS DynaCellect Magnetic Separation System
• Enables consistent performance in light of biological variability within processes
• Is suitable for both autologous and allogeneic cell therapy manufacturing processes

Coated with camelid-derived single-domain VHH antibodies that target CD3 and CD28 cell surface markers, these Dynabeads magnetic beads provide both the primary and co-stimulatory signals that are required for activation and expansion of T cells. An accompanying release buffer within the kit has an active ingredient, biotin, that competitively displaces a biotin derivative on the surface of the beads. This proprietary mechanism allows users to achieve active release of the beads from target cells at any time within their process.

Based on a recommended 3-to-1 bead-to-target-cell ratio (not total nucleated cell number), the smaller kit size can theoretically isolate and activate up to 1.33 x 10⁹ T cells. The larger kit size can theoretically isolate and activate up to twice that number of cells.

The CTS Detachable Dynabeads CD3/CD28 Kit also includes Drug Master Files (DMFs) for each of its components to support cross-referencing in regulatory submissions prior to clinical trial and commercial manufacturing use.