With increasing numbers of early phase and orphan disease molecules, the industry has started investing in manufacturing processes that emphasize speed and flexibility. One component of such manufacturing processes is single-use technologies. A gap in single-use technologies is high concentration TFF operations, where single-use options have not kept pace with reusable cassettes. Many manufacturers struggle to achieve target concentrations in reasonable process times while maintaining high product recovery when utilizing single-use TFF systems. This presentation will summarize data evaluating MilliporeSigma’s Pellicon® Capsule for single-use TFF operations as compared to Biogen’s current single-use Sius TangenX filters, as well as reusable Pellicon® 3 TFF filters. The Pellicon® Capsule simplifies installation compared to other TFF formats and potentially offers a simpler scale up model from Biogen’s single-use manufacturing facility to Biogen’s larger scale 2k and 15k traditional facilities. Experimental and modeling data for both UFDF and SPTFF mode will be presented, and the impact of this disposable filter will focus on increasing final concentrations in Biogen’s single-use facility from 50 g/L to 150 g/L by changing single-use TFF formats.

Evaluation of single-use TFF technologies for high concentration operations

255th National Meeting (2018)

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