Trending at the leading edge
Contract manufacturing organizations (CMOs) are typically on the leading edge of new biopharmaceutical manufacturing technology adoption, as evidenced by many CMOs hiring for positions like ‘technology scout’ and ‘director of innovation’. CMOs tend to be at the forefront of newer device adoption due to their business models, which see them handling multiple products that require a high degree of flexibility. If they can successfully adopt acceptable technologies more rapidly, they can establish themselves with a competitive advantage. Their rapid adoption of single-use and disposable equipment over the past 10 years is an example of this trend.
Examining CMOs’ attitudes towards new technologies, then, can provide a window into the devices and applications that may make significant inroads in the biopharmaceutical manufacturing community in the years to come. Our latest annual study, the 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production1, provides us with a variety of insights as to how CMOs are approaching innovation this year.
Figure 1. Single Most Important Biomanufacturing Trend or Operational Area, CMOs vs. Biotherapeutic Developers (Select Responses)Single-Use Innovation and Downstream Processing Advances Are Important to CMOs
Before delving into the data on CMOs’ new product development areas of interest, it’s worth contextualizing their attitudes within the framework of the issues that matter most to them this year. And on this count, CMOs show some interesting divergences from biotherapeutic developers.
When we asked CMOs to identify the single most important biomanufacturing trend or operational area that they feel the industry must focus its efforts on this year, a leading 31.6% pointed to manufacturing productivity/efficiency. This in itself – as a key priority – was not too much of a surprise, having been the leading trend for the community overall since we began asking this question a few years ago.
Beyond the need for manufacturing productivity and efficiency, though, CMOs offered some interesting viewpoints:
- Continuous bioprocessing was cited as a leading trend by 21.1% of CMOs, compared to 15% of biotherapeutic developers;
- More than 1 in 10 (10.5%) indicated that downstream processing advances represent their top trend, compared to 7.9% of biotherapeutic developers; and
- CMOs were twice as likely to say that single-use innovation (better devices – 10.5%) is their top trend than to say the same about single-use implementation and integration (5.6%), whereas biotherapeutic developers are more interested in implementation (10.7%) than innovation (6.4%).
These responses already offer some broad insights as to the innovation areas that matter most to CMOs: continuous bioprocessing; downstream purification; and single-use app-lications. In fact, rather than being disparate areas, these often overlap, as demonstrated by research data elsewhere in our report.
CMOs Desire Continuous Bioprocessing Innovation
When we asked CMOs to choose the top 5 areas – from a list of 23 – they would want their suppliers to focus their development efforts on, respondents placed continuous bioprocessing – downstream third on the list, with 42.1% of CMOs indicating that this is one of their top 5 areas of desired innovation. We note that as yet, there are few current upstream continuous bioprocessing innovations, and even fewer emerging technologies that may be able to address continuous downstream operations - thus, CMOs’ interest in this area may reflect a desire for devices, rather than actual expectations of near-term developments.
While continuous downstream bioprocessing topped the list among biotherapeutic developers, their desires were spread more evenly among the various options. This area was actually cited by a smaller share of biotherapeutic developers than CMOs.
CMOs also placed continuous upstream bioprocessing high as a desired innovation (31.6% citing), compared with 24% of biotherapeutics developers.
Looking further at continuous bioprocessing adoption, we discovered that:
- Half of CMOs will be actively evaluating or testing continuous downstream bioprocessing technologies over the next 12 months, compared to fewer than one-quarter of biotherapeutic developers; and
- Likewise, half of CMOs will be actively evaluating or testing continuous upstream bioprocessing technologies over the next year, compared to fewer than one-third of biotherapeutic developers.
Single-Use Innovation Tops CMOs’ Wish List - Again
Continuous bioprocessing is a hot topic this year, but single-use devices continue to top the list of CMOs’ innovation desires this year. Indeed, the top products and services CMOs want their suppliers to focus on this year are:
- Disposable purification products (52.6% citing as being among their top 5);
- Disposable products, bags connectors, etc. (47.4%);
- Disposable bioreactors (42.1%);
- Continuous bioprocessing – downstream (42.1%);
- Disposables probes, sensors, etc. (36.8%); and
- Chromatography products (36.8%).
Compared to last year’s results, our study this year finds more interest on the part of CMOs in disposable products, bags and connectors as well as disposable bioreactors, with less interest in chromatography products.
It’s worth noting – as mentioned above – that CMOs’ innovation desires in the areas of downstream and single-use are very much interlinked, as demonstrated by their top area for innovation (disposable purification products). CMOs continue to seek advanced solutions in this area because they’ve seen some successes here: the use of single-use, disposable downstream devices was one of the top actions taken by CMOs last year that improved their downstream purification operations.
Better single-use devices can also lessen capacity constraints in CMOs’ eyes. Capacity constraints are typically tied to downstream purification problems, whether they arise from chromatography, ultrafiltration or other step.
To combat future capacity constraints, CMOs feel that the most important areas to be addressed today are the development of:
- More cost-effective disposable, single-use products (58.8%);
- Better-performing disposable, single-use products (52.9%); and
- Better downstream continuous bioprocessing (52.9%).
Which Downstream Purification Technologies Are CMOs Considering?
This year, all of the CMOs we surveyed said that they are actively considering at least one new downstream purification technology to address production issues or problems. The most popular ones under consideration by CMOs are: in-line buffer dilution systems; single-use disposable TFF membranes; single-use-prepacked columns; use of high capacity resins; and use of filters instead of resin chromatography.
Interestingly, only one of these top 5 areas figured into biotherapeutic developers’ top 5: use of high capacity resins. Instead, biotherapeutic developers tend to put more weight into technologies such as buffer dilution systems/skids, membrane technology, and single-use filters.
Meanwhile, although several of CMOs’ top downstream technologies in consideration this year are consistent with last year’s results, there are a couple of areas in which we observe some interest this year where none was apparent last year. These include on-line analytical and control devices, two-phase systems and countercurrent.
Will CMOs Spend on Innovation?
Wish lists, of course, mean more when backed up by budgets. To see if CMOs are intending to back up their innovation desires with budget hikes, we analyzed planned budget shifts for the year ahead.
We found that the area where most CMOs are planning a budget increase is new capital equipment, where virtually all (94.1%) expect some degree of funding hike. This was followed by hiring areas (new operations staff and new scientific staff), where there was also broad enthusiasm for budget increases.
Budgets for new technologies weren’t far behind, though. Indeed, more than 8 in 10 CMOs surveyed said they would increase their spending on new technologies to improve efficiencies and costs for downstream production, averaging an estimated 10% increase in funding. Budget enthusiasm for upstream showed more than 3 in 4 (76.9% of ) CMOs plan to increase spending on new technologies to improve efficiencies/costs for upstream production, for an average increase of 7.9%.
Interestingly, new capital equipment is also the area tabbed for the largest spending increase among biotherapeutic developers, with new downstream technologies also slated for a slightly larger budget hike than new upstream technologies.
Conclusion
Results from our study show that CMOs remain focused on new technologies, paying more attention to single-use innovation. CMOs’ innovation desires appear to be spread across single-use devices, continuous bioprocessing and downstream advances, converging at least in part on the latter: downstream purification. In other words, CMOs are most interested in the development of downstream bioprocessing solutions, and the single-use, and continuous devices that can help improve downstream performance and avoid capacity constraints. This focus on downstream rather than upstream advances is borne out in budget trends, too, with CMOs forecasting greater budget hikes for downstream innovation than upstream.
References:
- 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2016, Rockville, MD www.bioplanassociates.com/12th
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. [email protected] 301-921-5979. www.bioplanassociates.com
Survey Methodology: The 2016 Thirteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from over 200 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (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.