(191bn) Polysorbate 80 Disposition Following Tangential Flow Filtration
AIChE Annual Meeting
Monday, October 30, 2017 - 3:15pm to 4:45pm
By better understanding the mechanisms effecting PS80 disposition after TFF, new insight can be gained as to how PS80 could be best used upstream of TFF to increase drug product quality while maintaining predictable output stream composition. For this study, several experiments were performed to evaluate the effect of key filtration and TFF parameters on PS80 disposition. One such experiment included centrifugal filtration or depth flow filtration to assist with the screening of parameters non-specific to TFF such as PS80 concentration, protein presence, and membrane molecular weight cut off (MWCO). These experiments showed that the main contributions to PS80 retention is protein presence and protein concentration. The potential presence of larger non-spherical micelles due to high PS80 concentration does not inhibit PS80 removal. This presentation will review different approaches used to study which factors impact PS80 retention and removal and how final PS80 compositions may be predicted when it is introduced upstream of TFF.