Cell therapy for spinal cord injuries: Commercial manufacturing facility
Abstract
There are over 250,000 Americans who live with a spinal cord injury. Recently there have been studies that indicate that adult stem cells could provide a way to treat these spinal cord injuries and restore function to those individuals who have been injured. In order to do this, a process would need to be designed that could produce enough cells to consistently provide a large number of treatments. This paper details a design of a manufacturing facility for spinal cord treatments from adult stem cells. The facility will be able to receive cryogenically frozen adult stem cells, thaw them, grow them into a larger quantity, differentiate them into the desired neural stem cells, purify the cells of incorrectly differentiated cells, separate them into the appropriate amount of cells required for one treatment and prepare them for shipping to off-site packaging. The facility also has several other components that are required for the process. This includes: storage on site for growth media and differentiation media, a quality control lab in order to ensure each batch is created successfully and is safe for use, storage of the finished product, and a disposal system to neutralize all wastes. At its highest production capacity, each spinal cord treatment could be sold for $508 and this would result in a 50 % rate of return. Based on the design feasibility and economic analysis, this process is recommended to be further explored and detailed design started.