BioMagnetic Solutions is commercializing its Clinical-Scale Cell Separation system called X-GRAFFE™ (eXternal GRAdient FerroFluid-Enabled). X-GRAFFE™ is a patent-pending immunomagnetic cell selection system. X-GRAFFE™ leverages the key properties of BioMagnetic Solutions’ proprietary XpresSep™ Ferrofluids that have highly rapid binding kinetics, biocompatibility, and a magnetic moment that enables cell separation using external magnetic gradients. X-GRAFFE™ enables cell separations to be performed in a closed system using inexpensive, single-use components. The X-GRAFFE™ cell selection platform is appropriate for a wide range of clinical applications, e.g., the manufacture of CAR-T cell & gene therapy products.
Employing XpresSep™ Ferrofluids, X-GRAFFE™ can isolate target cells with very high purity, excellent viability, and unmatched cell yields. For example, X-GRAFFE™ has been used to gently and rapidly isolate CD3+ cells from leukapheresis products with 97% purity, 98% viability, and 93.1% yield.
X-GRAFFE™ can be used to select T cell subsets (e.g., CD4+ and CD8+ cells), regulatory T cells (Tregs), NK cells, CD34+ stem cells, and for depleting unwanted cells from cellular products (e.g., removing T cells from purified stem cell products to prevent GVHD). X-GRAFFE™ can also perform negative cell selections for cell products requiring untouched cells. A releasable Ferrofluid to permit particle-free cell separations is in development