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The biopharma industry has seen dramatic improvements in upstream manufacturing yields over the past 30 years, however, increased efficiencies in upstream operations have contributed to downstream bottlenecks.
According to preliminary results from our industry study, 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, a majority of biotherapeutic developers continue to suffer capacity constraints as a result of downstream processing.
This is certainly not a new problem and there is obviously a lot to be gained from improving downstream operation.
According to survey results, the top way in which organizations tackle the problems associated with downstream processing is by optimizing running conditions.
Aside from tracking the activities implemented by the industry to improve downstream operations, it is also important to measure the new downstream purification (DSP) technologies that respondents are actively considering to address production issues. In our results to-date, respondents actively considering at least one of the 22 new DSP technologies identified, were led by Continuous purification systems (60%); Disposable UF systems (48%); and Single-use filters (48%).
The apparent increase in active consideration of continuous purification technologies this year is interesting, as development of these technologies tends to have lagged behind advances in upstream continuous bioprocessing, with new bioprocessing methods typically pairing continuous upstream processing with conventional batch purification.
An interesting trend continuing this year: although a significant portion of biomanufacturers are investigating alternatives to protein A, few have actively switched to alternatives. While Protein A affinity chromatography has been targeted for replacement due to high acquisition costs and limited recycling, few alternative options have emerged to pose a real challenge to conventional resins.
For now, technological innovations in downstream purification have yet to lead to the same productivity improvements experienced in upstream operations and it remains to be seen when downstream innovation will make up that deficit.