(518b) Dendrinow: Automated Dendritic Cell Production

In the last five years, autologous dendritic cell therapies have become one of the most promising candidates for anti-cancer treatment. Dendritic cells represent the bodyâ??s immunological memory and the means by which the immune system targets various diseases. Autologous cell therapies utilize patient-specific cells, which is advantageous to minimize the chance of host-rejection. Prior studies have proven the effectiveness of these treatments. Phase II clinical studies in India were able to prolong refractory cancer patientsâ?? lives from an expectancy of less than three months to a median overall survival of 397 days. With nearly 15 million people in the United States affected by cancer, the need for additional cancer therapies has increased the expected market value to $2.2 billion by 2017. Currently, dendritic cells are generated in a small lab-scale setting which presents major regulatory, documentation, and quality concerns to be addressed during scale up. In addition, dendritic cells do not reproduce, therefore many manufacturing lines or unit operations are necessary to produce the desired amount of product. The primary goal of the DendriNow system is to culture dendritic cells from CD14⁺ peripheral blood mononuclear cells (PBMCs). This system includes two components: a skeleton incubator system and a disposable cell culture kit. Key process changes were also incorporated into the DendriNow system to maximize the yield of dendritic cells. DendriNow will provide research institutions and companies the means to easily produce dendritic cells in a more cost-effective and timely manner, with the ultimate goal of accelerating the further investigation of dendritic cell therapies.