There is an existing need for more efficient cell culture devices that retain the simplicity of traditional devices such as flasks and roller bottles. Approval of this grant will initiate the investigation of a low profile static cell culture device (LPD) that is expected to meet this need. Preliminary data shows the LPD can eliminate the gas/liquid interface present in traditional static devices, and yet still retain an extremely simple format. The LPD is expected to be an easy to use device that can maintain equivalent output as traditional flasks with a 20-fold reduction in the amount of space it occupies. That will make it substantially more efficient in terms of shipping, sterilization, storage space, incubator space, labor, and disposal cost. Importantly, the LDP is fully scalable so these advantages are captured as applications move from research to production. Two configurations of the LPD are envisioned. One has gas permeable device walls and the other does not. This investigation determines quantitatively how well each configuration compares to a commercially available tissue culture flask in biological applications using BHK and murine hybridoma cells for generation of secreted products. Our hypothesis, based upon preliminary data is that the LPD will demonstrate equivalent output as the flask when normalized for the quantity product produced per volume of space occupied by the device and when normalized for product quantity per ml of medium consumed. The LPD is particularly advantageous for applications that are subject to regulatory bodies. It is expected to provide the foundation for a far superior culture process than currently available devices can deliver. Substantial cost savings are expected to accrue from a variety of advantages including reduced facility space and complexity, more simplified process automation, reduced contamination and cross-contamination risk, reduced labor, and tighter process control capability. This is expected to be particularly helpful in cellular therapy applications and in particular, autologous cell culture applications. The overall impact of the LPD will be to cost reduce cellular therapy research and delivery to society
