Advances in large-scale production of mammalian cells or their secreted proteins have led to the licensure of many therapeutic and diagnostic products. Culture devices, such as stirred-tank and hollow fiber bioreactors, have utility in large-scale production, but are impractical and cost prohibitive at the research scale. Traditional roller bottles have been used successfully for small to mid-scale production of recombinant proteins, viral vectors, and therapeutic cell doses, but are labor intensive, typically requiring more than ten devices for each desired product. The Enhanced Roller Bottle (ERB) is a practical, cost effective cell culture device designed to improve culture productivity. The ERB increased cell production 4- to 9-fold over the traditional roller bottle by increased surface area for cell attachment and increased availability of culture medium due to its gas permeable walls. In the proposed Phase II studies, the ERB will be optimized for the production of anchorage-dependent cells and cell-secreted products. ERB parameters requiring investigation include gas transfer, scaffold configuration and material, inoculation methods, operating conditions, and product recovery. At the completion of Phase II, the ERB will be targeted to manufacturers of small and mid-scale culture devices for the production of cells or cell products for diagnostic and therapeutic applications.
