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Downstream processing continues to impact capacity at the majority of biopharmaceutical manufacturing facilities, and industry respondents are clamoring for advances in this area, according to our soon-to-be-released 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production [1].  

Indeed, manufacturers we surveyed for this year’s report are considering a range of new technologies to help ease the bottlenecks they’re currently experiencing.

Downstream processing’s inability to keep pace with upstream advances in recent years have been well-documented, and our annual studies have shown for some time that downstream is contributing to significant capacity bottlenecks at respondents’ facilities. With that in mind, it’s not too surprising that many biomanufacturers are insisting that the industry focus on downstream advances this year.

When we asked industry respondents to identify the single most important biomanufacturing trend or operational area that the industry must focus its efforts on this year, downstream processing advances emerged as the second-leading area.

So, for the industry as a whole, downstream processing now ranks as a bigger concern than manufacturing cost reductions and single-use system integration and implementation.

This year’s result marks a significant departure from last year, when downstream processing advances ranked as only the 6th-most important trend to respondents, behind the likes of biosimilars and continuous processing. As such, the industry appears to be coming to the conclusion that it’s time for downstream processing advances to emerge.

Which Downstream Innovations Are Most In-Demand?

Almost all (97.4 percent) of qualified industry respondents this year said that they are considering new downstream purification technologies. Presented with a wide range of technologies, the following emerged as those most broadly in active consideration to address production issues or problems:

The results contain some interesting divergences from last year. For example, active interest in continuous purification systems showed a significant rise from 32.4 percent of respondents last year to half in this latest report, while fewer respondents this year expressed interest in membrane technology, one of last year’s leaders (39 percent vs. 49 percent).

Also of note: More than one-third (37 percent) of respondents this year reported actively considering alternatives to chromatography, with this representing a large increase from last year’s 21 percent, and by far the largest share of respondents signaling an interest this decade.

The uptick in consideration of chromatography alternatives aligns with separate results from our survey indicating close attention to chromatography. In fact, when we asked industry respondents to consider the new products and services suppliers develop, and identify the top five (from more than 20) they would like their suppliers to focus developments effort on, we found that chromatography products tied for the top ranking, cited by 36 percent of respondents.

Tellingly, chromatography products were joined at the top by disposable purification products (also 36 percent), supporting the industry’s need for advances in downstream processing. Last year, these areas ranked 5th and 6th, respectively, in terms of new product development areas of interest.

The industry’s renewed attention to downstream processing advances appears to be backed by budget increases, too, as almost two-thirds (66 percent) of survey respondents said they would increase their funding for new technologies to improve efficiencies/cost for downstream production. That led all areas, surpassing the 62 percent planning increases in new capital equipment spending and the 59 percent expecting to grow their budgets for process development.

Those latter areas will see more significant budget increases, though, as new capital equipment spending is tabbed for an overall spending increase of 6.1 percent, compared to a 5.3 percent hike for process development and a 5.2 percent estimated increase for new downstream production technologies. Nevertheless, the 5.2 percent growth for downstream technologies ranks as the largest forecast increase in this area since 2012.

How Are Manufacturers Improving Downstream?

Interest in novel technologies is clearly growing, but it’s also important to see what biomanufacturers have been able to successfully implement to improve their downstream operations. We investigated this topic, finding a large portion of respondents implemented the following during the 12 months prior:

  • Optimized running conditions (51.2 percent)
  • Developed downstream processes with fewer process steps (47.6 percent)
  • Investigated single-use disposable downstream technologies (46.3 percent)

For the most part, these were also top-ranking areas last year, with the use of disposable downstream technologies and membrane-based filtration technologies each creeping up slightly in the rankings. By contrast, fewer this year report having used or evaluated ion exchange membrane technologies and alternative ion exchange technologies.

It’s also worth noting that this year, 8.5 percent said they switched to protein A alternatives, up from 6.9 percent.

Conclusion

Results from our 12th annual survey of the biomanufacturing industry show that downstream processing is rising in importance in the minds of many, to the point where it is one of the most critical areas facing the industry today. In response to continued bottlenecks – with 46 percent of respondents experiencing “serious” or “some” bottleneck problems owing to downstream processing – the industry is looking to downstream processing advances to provide it with answers.

Not only are chromatography products and downstream purification products atop the list of new technologies in demand, but anticipated spending on new downstream technologies is also up from the past couple of years, with those budgets potentially spent on continuous purification systems and chromatography alternatives, which are being actively considered by a growing share of industry respondents. In other words, this could be an interesting year for downstream processing.

References:

1.  12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Inc. Rockville, MD., April 2015

Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing firm established in Rockville, MD in 1989.

Survey Methodology: The 2015 Twelfth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from over 230 responsible individuals at biopharmaceutical manufacturers and CMOs in 30 countries. The methodology also included over 150 direct suppliers of materials, services and equipment to this industry. This year's study covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time, and assesses differences in the world's major markets in the U.S. and Europe.

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