(348f) Large-Scale Pool-Less Purification

As fermentation and cell culture titers approach 5 g/L, the purification trains in existing manufacturing plants are becoming seriously undersized. Existing plants can expand their capacity by buying larger equipment and chromatography columns. However, the tank volumes required to run the columns may be space and cost prohibitive. Possible approaches to solving this challenge include the use of on-line dilution to reduce buffer volumes and eluting columns directly onto successive columns to eliminate pooling tanks. In this talk, we will describe the development of a clinical-scale ?connected process?. Additionally, we will discuss potential challenges associated with this strategy and attempt to address the question of general applicability.