(385b) Use of Single-Pass Tangential Flow Filtration for Decoupling Upstream and Downstream Processing

Higher cell culture productivity has led to a bottleneck during downstream purification.  Various ways have been explored to decouple the upstream and downstream processes to allow for more flexible processing and enable the more efficient use of existing facilities.  In this presentation, we will explore the feasibility of using tangential flow filtration to provide decoupling by concentrating and freezing centrate.  However, traditional fed-batch tangential flow ultrafiltration (TFF) can be limited due to the size and minimum working volume of TFF systems. Single-pass tangential flow ultrafiltration (SPTFF) provides a viable solution by providing high concentration factors without the need of a recirculation vessel. This reduces overall system size and hold-up and enables concentration in-line with other operations. The SPTFF process was developed at bench scale to determine the appropriate operationg conditions for the desired concentration facter, and then demonstrated at pilot scale to show scalability and evaluate the effect on the downstream purification steps and product quality.