(511d) Modeling Buffer Preparation Operations for Downstream Processing

In most biopharmaceuticals processes, the downstream purification is dominated by chromatographic separations, which require the preparation, holding and distribution of numerous buffer solutions. Buffer preparation is a potential process bottleneck in high-capacity situations. This paper examines the use of macroscopic modeling techniques to evaluate buffer preparation for downstream processing. Cases studies will address the challenges in buffer preparation for multi-line facilities (that share buffer prep tanks), the impact of disposable containers on the demand for utilities and the cost of goods, and the effect of changes in bioreactor titer.