Over the past decade, single-use tangential flow filtration (TFF)
technologies have emerged to reduce system preparation time, promote
fast and flexible product change over, and ultimately shorten process
development and manufacturing time/cost. In this study, the performance
of a recently developed Pellicon® single-use TFF capsule was compared
against traditional Pellicon® cassette by assessing TFF process
performance (such as flux, residuals clearance, and yield) and
post-purification product attributes (such as concentration and
mass-weighted average molecular weight). Good scaling was shown by
comparing process performance and product attributes across different
scales and formats. Additionally, similar TFF process performance and
post-purification product attributes were observed for the single-use
capsule compared to the reusable TFF cassettes. The capsule requires a
smaller flush than the cassette, and it is easier to use since it does
not require a compression holder or pre-sanitization. The results
provide insight into the application of the single-use TFF capsule and
scalability of TFF processes for the purification of conjugate vaccines.
Evaluation of Single‐use Tangential Flow Filtration Technology for Purification of Activated Polysaccharides Used in Conjugate Vaccine Manufacturing
