Since 2008, downstream purification issues have become progressively more acute problems for biomanufacturers. But that’s begun to change this year, according to results from BioPlan Associates’ 9th Annual Report and Survey of Biopharmaceutical Manufacturers.
In our study of 302 global biomanufacturers, we found that there are now fewer downstream processing “acute” problems (typically, capacity bottlenecks in chromatography and ultrafiltration steps), and more “chronic” ones associated with general operational inefficiencies. Facility budgets are funding downstream purification solutions that reduce the number of steps, improve performance, and lower costs.
Compared to prior years, we are seeing a notable decrease in the percentage of global biomanufacturers that expect to move away from Protein A purification. For example, the industry’s interest in alternatives to Protein A for existing production units dropped from 27.1% in 2009 to 15.5% this year (Figure).
Although a majority of respondents are still interested in improving their downstream processing, and Protein A chromatography, they display less conviction about actually doing so. From our report, 21.1% of respondents said they had investigated alternatives to Protein A to improve downstream purification operations (down from 31.1% in 2011), but just 11.8% had actually switched to alternatives.
Some of this may be attributable to a gradual lessening of impact of downstream chromatography on capacity levels. This year, 17.5% of respondents said that chromatography steps create “significant” or “severe” capacity constraints at their facilities. That’s a slight increase from 14% last year, but is lower than in prior years (2010: 18.9%; 2009: 21.6%; 2008: 20.2%).