Precision Lifesciences Group’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 Precision Lifesciences Group GMP manufacturing process adheres strictly to standard operating procedures to ensure consistency, quality and sterility.
1. The apheresis product, which consists of precursors of dendritic cells (DC), are isolated or separated from other cells.
2. Monocytes are suspended in a "cocktail" of culture media and cytokines and then cultured to differentiate them to DCs.
3. Monocytes and subsequently stimulated with additional stimulating agents to become matured DCs.
4. The mature DCs are "pulsed" with specific antigenic peptides which bind to receptors on the surface of the DCs. These peptides induce immune responses to the proteins found on the tumor and tumor stem cells. For ICT-107, there are six specific peptides. For ICT-121, there are two specific peptides. For ICT-140, there are seven specific peptides. The DCs with bound peptides are again washed to remove all of the media with which they have been treated.