CONCLUSIONS

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, *swaugh@cmcbio.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).