A single-pass tangential flow filtration (SPTFF) unit operation was developed to enable the fit of a monoclonal antibody (mAb) downstream process to an existing facility. The goal of the additional unit operation was to reduce the size of a large volume intermediate as well as minimize the time and cost of viral filtration in the process. Initial studies were completed with a single TFF membrane to estimate the maximum wall concentration (CW) and to correlate the mass transfer coefficient with the potential range of feed flux. These parameters were used to predict SPTFF performance using a previously developed approach (Teske et al., 2010). The model was used to predict concentration factors across single- and multi-stage SPTFF processes with varying membrane area ratios and flux; the predictions were compared to small scale experimental results. The performance of the viral filtration process was evaluated across the range of concentrations potentially achieved by SPTFF to determine the relationship of concentration and viral filter flux. The SPTFF process was then optimized by modifying the membrane area, flux and number of stages to improve facility fit, minimize the required virus filter area, and the overall processing time.

Single-pass tangential flow filtration (SPTFF) for process intermediate volume reduction

251st National Meeting (2016)

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