ImmunoCellular’s manufacturing process begins with an apheresis (also referred to as leukapheresis), a common procedure in which the patient’s blood is circulated through a machine to collect the white blood cells. These cells are treated with various reagents to induce production of dendritic cells, which are activated with peptides derived from tumor-specific antigens. In the final manufacturing step, DCs bound with peptides are formulated in an infusible solution, dispensed into individual vials, and cryopreserved (frozen) for shipping back to the clinical site, where they are administered to the patient.
The process, which takes only a few days to complete, is designed to generate sufficient cryopreserved cells for dosing through the induction and maintenance phases of immunotherapy. The ImmunoCellular GMP manufacturing process adheres strictly to standard operating procedures to ensure consistency, quality and sterility.