Pellicon® Capsules for Single-Use Tangential Flow Filtration

Abstract

Single-use TFF is used in biomanufacturing facilities to improve batch turnaround, process flexibility, and operator safety, all while reducing capital costs. The Pellicon® Capsule is the first of its kind — a true single-use TFF device that streamlines bioprocessing with its innovative, simplified design and user-friendly features. It features a holderless and torqueless design that reduces installation efforts, and the filter comes gamma sterilized and preservative-free, requiring minimal preparation before use.

The holderless, self-contained format allows for a disposable flow path in a single-use TFF assembly: the capsule is typically discarded along with the tubing without opening the wetted flow path. Without any cleaning operations required after product recovery, the total process time could be reduced by 30–40% compared to a multi-use process. Single-use TFF utilizing the Pellicon® Capsule conserves time and resources associated with cleaning regimes and cleaning validation requirements of conventional stainless-steel TFF operations. This decreases batch turnaround time for improved facility throughput, which is enhanced by the quick installation and reduced preparation time of the capsules, to ultimately increase speed-to-market.

With ease-of-use and reliable integration, the Pellicon® Capsules offer fast, flexible, and cost-effective manufacturing of mAbs and other therapeutic proteins.