Here again we find significant differences in approach when segregating by business model and geography. U.S. respondents are more likely to be considering technologies such as disposable UF systems, use of high capacity resins, and in-line buffer dilution systems, while European respondents are more favorable towards continuous purification systems, single-use prepacked columns, and membrane technology.
CMOs show a much greater interest than biodevelopers in use of high capacity resins, single use disposable TFF membranes, and continuous purification systems, while biodevelopers are more focused on buffer dilution systems/skids, single use filters, membrane technology, and precipitation, among others.
But What Is The Industry Actually Doing?
While it’s worthwhile to explore what new solutions are generally piquing the interest of global biomanufacturers, it’s also very relevant to examine the specific areas respondents’ facilities have actually implemented in an effort to improve their downstream purification operations.
We evaluated 18 factors being undertaken today. The most common approach that respondents are taking to reduce DSP problems is to simply “optimize running conditions,” which was cited by 43.4% of respondents (Figure 2). A similar proportion have used or evaluated membrane-based filtration technologies, and cycled columns more frequently. Other actions included “developed downstream processes with fewer steps” and “reduced the number of process steps.” Only about one in 10 have switched to alternatives to Protein A, an area in which there appears to be more interest than actual activity.
Generally, the areas that we also identified in last year’s study have seen a decrease in the percentage of respondents indicating implementation this year. Those include “use or evaluation of membrane-based filtration technologies,” “development of downstream processes with fewer steps,” “investigation of single-use disposable downstream technologies,” and “use or evaluation of ion exchange technologies.” The only area to see marginally higher take-up this year was “more frequent cycling of columns.”
There are a couple of different ways to interpret this trend. It could suggest that the industry is gradually moving towards a better balance in its downstream capacity, and that the recent bottlenecks are beginning to abate. This reading would follow the signs we found earlier, that while more facilities are experiencing bottlenecks, the problems are relatively minor in scope. This in turn could be the result of generally improved productivity in downstream purification operations, the implementation of better process monitoring, and/or improved technology adoptions.
Alternatively, the trend might indicate that respondents have already implemented the common operational improvements, so this year the industry is looking at other options. Indeed, the fact that we identified 19 DSP improvements suggests the industry is still seeking a cure.
Both CMOs and Western European respondents report a significant decrease in DSP bottlenecks this year.
And we found that in general, these groups differed in their approaches. Both CMOs and Western Europeans indicated use or evaluation of membrane-based filtration technologies to be their most common implementation area: 63.6% of CMOs reported having done so (compared to 38.5% of biodevelopers), and 52% of Western European respondents also reported doing so, compared to 35.9% of U.S. respondents.
This is an interesting development and it will be useful to monitor over time.
On the whole, results of this year’s study indicate a less dramatic impact from downstream processing on overall productivity and capacity. Biomanufacturers’ incremental fixes have moved the DSP pain from ‘acute’ to ‘chronic’ as problems are addressed. Perhaps as a result of these gradual fixes, the interest manufacturers are showing in more novel DSP approaches is declining, or being focused on fewer, more promising alternatives.
1. 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Survey of Biotherapeutic Developers and Contract Manufacturing Organizations, April 2012, BioPlan Associates, Inc., Rockville, MD, www.bioplanassociates.com
About the Author:
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. He is editor of numerous studies, including “Biopharmaceutical Technology in China,” “Advances in Large-scale Biopharmaceutical Manufacturing”, and many other industry reports. Contact information: email@example.com; 301-921-5979; www.bioplanassociates.com.
Survey Methodology: The 2012 Ninth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production by BioPlan Associates yields a composite view and trend analysis from 302 individuals at biopharmaceutical manufacturers and CMOs in 30 countries. It also included 185 direct suppliers of materials, services and equipment to this industry. This year’s survey 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.