Single-Use Technologies Used Less For Downstream Purification Issues: Interest In Specific Technologies Remains Relatively Steady

By Eric Langer, president and managing partner, BioPlan Associates, Inc.

Downstream operations continue to create challenging bottlenecks and capacity problems. To identify what the industry is doing to address these bottlenecks, we asked 302 biopharmaceutical manufacturers in our 9th Annual Report and Survey of Biopharmaceutical Manufacturers about the specific areas their facility has actually implemented to improve their downstream purification (DSP) operations. We found 19 key activities; selected results for 2011 and 2012. The proportion of biomanufacturers turning to single-use disposable downstream technologies actually fell rather substantially this year when compared to last, from 47.1% to 36.8%. This means that single-use technologies may be less a focus for improving downstream purification than other areas, including optimizing running conditions (43.4%), use or valuation of membrane-based filtration technologies (42.1%), or more frequent column cycling (42.1%). These data mirror downward trends regarding DSP operations in other study areas as well.