Clinical-Scale Separator (X-GRAFFE)

BMSS is finalizing the development of a Clinical-Scale Cell Separation system called X-GRAFFE (eXternal GRAdient FerroFluid-Enabled). X-GRAFFE, a patent-pending immunomagnetic cell separation system, utilizes key properties of BMSS’ proprietary 5th generation ferrofluids (highly magnetic colloidal nanoparticles functionalized with binding agents) i.e., rapid binding kinetics, biocompatibility and a magnetic moment that permits 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 separation platform is appropriate for a wide range of clinical applications, such as the manufacture of CAR-T cell & gene therapy products.

Employing BMSS’ common-capture ferrofluids, X-GRAFFE can isolate target cells with high purity, excellent viability, and unmatched cell yields.  As an example, X-GRAFFE has been used to gently and rapidly isolate CD3+ cells from leukapheresis products with 97% purity, 98% viability, and 93% yield.

X-GRAFFE can also be used for the isolation of 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. BMSS is currently developing a releasable ferrofluid for X-GRAFFE to permit particle-free cell product manufacture.