Transitioning from multi-use to single-use TFF was a simple and straightforward process and did not require a significant
investment of either time or resources. The transition was facilitated by a stepwise approach to a fully single-use flow
path by considering a change to single-use sensors in cGMP manufacturing as an independent project. The Sius single-use TFF
system is well suited for a 500-L production scale CMO manufacturing facility, or for a typical pilot plant. Performance
was comparable or slightly better than the traditional re-usable filters that had previously been used, and implementation
in cGMP manufacturing was straightforward. Changes to batch records and operator training were essentially limited to eliminating
several pre-and post-use operations. With a fully disposable flow-path, the system greatly simplifies product changeover,
reduces overall operating time by reducing the number of process steps, and the economics are still favorable relative to
multi-use filters for the typical clinical-stage manufacturing campaign.
BARBARA A. THORNE was a visiting scientist, STEVE WAUGH* is director, downstream process development, TODD WILKIE is a process technology specialist, and JOE DUNN is a principal development scientist, all at CMC Biologics, Bothwell, WA. MICHAEL LABRECK is global product manager, TangenX TFF Products at Novasep, *email@example.com
. B. A. THORNE is currently at Celladon Corp., San Diego, CA.
1. W.G. Whitford, BioProcess Intl. 8 (11), 34–42 (2010).
2. M. LaBreck and M. Perreault, "Guide to Disposables Implementation," supplement to BioPharm Intl. 23 s32–s38 (2010).
3. E. Miller-Cary, G. Annathur, and J. Glynn, presentation at IBC's 6th International Single-Use Applications for Biopharmaceutical
Manufacturing Conference (La Jolla, CA, June, 2009).