Advantages and Limitations of Single-Use Systems in Downstream Processing

Biopharmaceutical downstream processes are generally dominated by chromatographic separations and membrane filtrations. Single-use systems can increase the efficiency and reduce the costs of these processes, but there are limitations. A common target for single use technology is the preparation, holding and distribution of the numerous buffer solutions required in downstream processing. Buffer preparation may become a capacity-limiting process (bottleneck) in certain high-capacity situations. This paper examines the use of macroscopic modeling techniques to evaluate buffer preparation for downstream processing.  A series of cases studies are based on downstream processing for a 2000 L mammalian cell-culture process. Single use buffers offered a number of advantages including  a 34% savings in capital costs, a 20% reduction in purified water usage, up to 20% reduction in unit and potential throughput advantages. The cost advantages decline with increased protein load on the process. Furthermore,  this study explores facility floor-space limitations that become important when large numbers of disposable containers need to be managed.