Ultrafiltration/Diafiltration is the unit operation in place in industry dedicated to small molecule clearance and protein concentration. The presence of the recirculation loop in tangential flow filtration (TFF) is problematic for several reasons, including the recovery dilution, minimum working volume concerns, high viscosities and channel induced shear due to pumping for high concentration antibody formulations. This work examines the use of single-pass TFF (SPTFF) for both protein concentration and diafiltration for producing the drug substance. To this end, different types of screen channels (tight screen, moderately coarse screen, coarse screen and suspended screens) are evaluated in SPTFF mode to obtain their hydraulic characteristics for protein concentrations as high as 250 g/L. A novel SPTFF approach to reach high concentration factors (upto 80x) starting from a dilute solution of 3 g/L was developed. The novel method allowed operation at upto 30 to 50% higher feed flux-rates compared to conventional SPTFF recommendations. The findings from this work would enable flexible manufacturing through process integration and continuous bioprocessing of the drug substance.<br/>

Implementation of single-pass tangential flow filtration for inline concentration and production of drug substance: Module effects and diafiltration

253rd National Meeting (2017)

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