When it comes to the adoption of disposables in biopharmaceutical manufacturing the rate continues to grow, as it has for the past several years. This is especially true in relation to pre-commercial scale production, including clinical and preclinical applications.
The industry is hungry for innovation in this area, and end-users continue to seek better ways to speed campaign changeovers, reduce shut-down times in the production of monoclonals and lower overall production costs. Single-use systems are now being used for a wide range of applications including upstream expression, filtration, purification, storage, mixing, processing and separating biotherapeutics. Some single-use equipment use is almost ubiquitous at the early stages of manufacturing, which begs the question: Which areas are seeing the greatest upswing in recent implementation?
Our newly released 10th Annual Report and Survey of Biopharmaceutical Manufacturers, offers some insight into areas that have seen recent growth in disposables implementation. As part of our study — which takes an in-depth look into trends in this area — we asked 238 biomanufacturers to indicate which disposable systems had been introduced at their facilities over the past 12 months.
For the third consecutive year, we found that “bioreactors, production” were the leading “newly introduced” system, cited by 46.6% of respondents this year. That follows a large jump last year, as well as in 2010. The data suggests that the rate of implementation of disposable production bioreactors has steadied, perhaps likely due to these companies nearing a level of maturity in adoption, at least at pre-commercial scale.
Next on the list we find buffer storage, noted by 40.9% of respondents, up from roughly 35% last year. Bioreactors, seed (37.5% having newly introduced), buffer prep (30.7%), and mixing (28.4%) round out the top 5 newly introduced systems, although recent implementation rates of each of those has slowed from previous years.
Beyond those top 5 (see Figure 1), some noteworthy changes in this year’s data include:
- Media storage, newly implemented by 27.3% of respondents, the highest level in at least 5 years;
- Tangential flow filtration, newly implemented by 19.3% of respondents, rebounding after 3 consecutive years of decline;
- Filtration (normal flow), newly implemented by 17% of respondents, down significantly from 30.5% last year and 37% in 2011; and
- Seed train, newly implemented by 13.6% of respondents, the lowest level in several years.
We note that respondents could be mistaken in their estimate of when introduction took place and they could be mixing up major purchases with new introductions, so there may well be overlap between previous years’ responses about when products were implemented. However, we see much consistency from 2007 to the present, so these data are useful for their relative values and trends.
Disposable Devices Penetration Of Commercial Stage
Given strong rates of recent implementation for some devices across a growing time span, it’s easy to understand how certain disposable devices have reached widespread use in the industry. This year, for example, we find that among users of disposables, at least 8 in 10 report using disposable filter cartridges (92%), tubing for disposable applications (88%), depth filters (85%), buffer containers (82%) and media bags, purchased dry (81%) at some stage of R&D or manufacture. In fact, these devices have become the primary option, with 100% of our CMO respondents reported adoption of common devices such as disposable filter cartridges. CMOs also indicate strong adoption of other systems such as waste containers (78.6% of CMOs versus 57% of biotherapeutic developers).
Of course, it’s widely accepted that within the industry single-use devices are mostly used in scale-up and clinical production rather than in commercial production. Yet even on this front, our data shows that some applications are making inroads.
Bioreactors certainly stand out in that regard. This year, 53.2% of respondents reported using bioreactors in commercial production, more than double last year’s 25.3%. That suggests that those respondents who newly introduced bioreactors into their facilities in the past year may have deployed them in the commercial stages of production.
Bioreactors aren’t the most commonly used device at the commercial stage of manufacturing. That distinction belongs, not unexpectedly, to tubing for disposable applications, used by 60.2% at commercial stage, up from 49.5% last year. Pre-assembled tubing sets, rigging kits, etc. (57.1%, up from 50%) aren’t far behind, with a majority also using disposable filter cartridges (52.2%, relatively flat from 53.8%) and tangential flow devices (52.2%, up from 36.9%) at the commercial stage.
Not So Fast
Not all single-use applications are seeing increased adoption at the commercial stage, though (see Figure 2). Some appear to have leveled off this year, including:
- Connectors, clamps, for commercial production this year, around 50%;
- Mixing systems, down to 35% from 42% in 2012;
- Waste containers, down from 46% in 2012 to around a third of respondents this year;
- Single use sampling systems, appear to have declined at commercial stage, down to 25.6% this year.
A Fully Disposable Facility?
While not all single-use applications are making their way into commercial stage, data from our study suggests that disposable products will become more pervasive in the latter stages of manufacturing. But what about a 100% disposable facility? We posed the question to the industry, finding that more than 4 in 10 respondents either strongly agree (18.4%) or agree (27.6%) that they expect to see a 100% disposable facility in operation within five years. Confidence in such a scenario was significantly higher among U.S. (57.1%) than Western European (43.5%) respondents. In fact, American respondents were as likely to agree that they expect to see a 100% disposable facility in operation within five years as to agree that they expect to retrofit existing facilities with disposables, rather than designing entirely new facilities.