by Lisa Hami, Harjinder Chana, Vivian Yuan, and Stewart Craig, PhD
Volume 2, Issue 6 (November/December 2003)
Xcyte Therapies has recently introduced a bioreactor-based process for the GMP manufacture of autologous activated T cells, Xcellerated T Cellsā¢, for clinical trials. Using a single customized disposable 20-L Cellbagā¢ with a working volume of 10 L on a customized Wave Bioreactor platform (Wave Biotech, Bridgewater, NJ), the Xcellerateā¢ III Process has supplanted the 60-L static Xcellerate II Process that used 60 bags cultured in a standard incubator. Compared to the Xcellerate IIā¢ Process, the Xcellerate III Process significantly reduces the overall labor, the number of culture containers, bag spikes, and sterile connections required, as well as reducing the process volume and the cost of goods, while more than quadrupling the final cell density and doubling the facility capacity. These process improvements are achieved without compromising final product composition or quality…
Citation:
Hami L, Chana H, Yuan V, Craig S. Comparison of a Static Process and a Bioreactor-based Process for the GMP Manufacture of Autologous Xcellerated T Cells for Clinical Trials. BioProcess J, 2003; 2(6): 23-34.