Conversion of a fed-batch process in wave bags to the Xcellerex single-use bioreactor system using PER.C6 cells

Performance of a recombinant protein producing PER.C6 cell line was evaluated in a 10L Xcellerex (XDR-10) single-use bioreactor system and compared to an established 20L disposable wave bag process. Some of the challenges with PER.C6 cells making it difficult to establish a process in a stirred tank bioreactor system involve shear sensitivity, cell clumping and a high oxygen demand. The well-characterized design of the Xcellerex disposable bioreactor may help overcome some of these challenges. Although both the XDR-10 and the wave bag system offer the benefit of a single use disposable technology, the Xcellerex 10L bioreactor delivers a wide selection of process control options and scalability, which are limited in the traditional wavebag system.  The aim of this experiment was focused on converting an established 20L wave bag process to a 10L single-use bioreactor system in order to optimize and generate a robust, scalable manufacturing process.  Overall, cell growth and productivity of the 10L bioreactor remained consistent with the wave bag, demonstrating a successful process conversion and functionality of the Xcellerex bioreactor system. The ability to regulate various process control settings with the XDR-10 allowed for establishment of a highly robust and scalable process, while maintaining expected culture performance.