Evaluation of Single-use Tangential Flow Filtration Technology for
Purification of Activated Polysaccharides Used in Conjugate Vaccine
Manufacturing
Abstract
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.