June 15, 2015 (Vol. 35, No. 12)

Earlier this year, GEN distributed a survey on single-use bioprocessing to over 100 leading industry experts. The results suggest that while industry continues to adopt disposable bioprocessing, old sentiments die hard.

GEN: Do you anticipate your company will use single-use components more or less over the next two to three years?

Respondents indicated overwhelmingly, 80% to 20%, that single-use bioprocessing would grow at their companies. The question is how much.

In their recent report on single use technology, Research and Markets predicted that annual growth in single use bioprocessing would exceed 38% during the period 2013–2018. The key driver will be rising demand for biopharmaceuticals, although regulatory issues persist.

Can the industry really sustain such growth? Our trusty Windows calculator tells us that five years of 38% compounded growth equals 3.6 times sales for the base year. Are vendors’ expectations in line with those numbers? GEN is interested in hearing from you on this point.

GEN: For which upstream component type will you see the highest growth at your company?

Here respondents were asked to choose two components. Buffer/media prep and cell culture bioreactors easily won this contest, with slightly fewer than 50% of respondents selecting them. These two applications, plus hold vessels (14% selected), are what everyone thinks of when they hear “single-use bioprocessing.”

The nearly one-to-one correspondence of these two critical single-use categories makes sense: The more cell cultures you run, the more buffer you will need. One would have expected, therefore, greater congruence with hold products because the more product you make, the greater the hold capacity you’ll need.

Interestingly, sensors and analytics came in a respectable third, selected by 34% of survey-takers. This is certainly encouraging for advocates of process analytic technology (PAT) and shows, at least, that bioprocessors’ interest in in-process quality assurance remains high.

Interest in single-use fermenters for microbial bioprocessing was remarkably high, 20%, despite the significant challenges for single-use equipment for these processes.

GEN: For which downstream component type will you see the highest growth at your company?

Those surveyed were asked to select two operations in the downstream category as well. Responses validated patterns gleaned from expert interviews for GEN features. Media/buffer storage easily won this contest at 60%, followed by harvest/depth filtration (42%), membrane adsorption (33%), and virus filtration (22%).

Downstream processing is a tough sell for single-use equipment because the costliest unit operations by far, column chromatography, are nowhere near the use-and-discard stage. The survey did not include a preparative chromatography selection, but it did include membrane adsorbers, which often replace more expensive and resource-intensive anion exchange columns for polishing steps. Anticipated usage of membrane adsorbers is therefore encouraging.

Virus filtration also has a reputation for being costly and requiring extensive validation. Given that factor, and the availability of chemical and heat inactivation as alternatives for some products, vendors should find the anticipated growth in virus filtration reassuring.

GEN: From your perspective, where do you see the greatest industry-wide growth over the next several years?

Here respondents were given three pairs of options to choose from: upstream/downstream operations, cell culture/fermentation, and vessel size larger or smaller than 200 L. Responses to the first question followed current industry practice: 60% believed upstream applications would grow; 40% believed downstream processing provided the greater opportunity.

Similarly, 78% believed that cell culture is where the action is, compared with just 22% for microbial fermentation. Given the known shortcomings in terms of size and oxygen transfer for most single-use microbial systems, the 22% figure is somewhat surprising. Perhaps the HyPerforma single-use fermentor system, introduced by ThermoFisher Scientific in October 2014, has broken the “plastic barrier” to an unanticipated degree. We are interested in hearing from other vendors with products for high-performance single-use microbial fermentation.

The third option for this question, bioreactor size, suggests approximately similar expected growth for vessels larger (56%) or smaller (44%) than 200 L. This cutoff volume was selected based on an arbitrarily assumed transition point from pilot plant to manufacturing scale.

Everyone knows that titers continue to rise, to the point where smaller vessels easily serve production of highly potent biomolecules. Perhaps, instead of asking for specific volumes, next year’s survey should ask about R&D vs. production scale.

GEN: Which factors are the most significant disadvantages or bottlenecks related to adopting single-use processing?

We asked survey-takers to select three from a list of nine concerns. At the top of the list was supply, at 64%. This may be an artifact, as two slightly different concerns related to supply and availability. These will be merged into one concern for the next survey. But even if the supply concern is attributed a score of 32%, end users do not appear to be entirely confident that they will be able to access critical supplies within their timelines.

Fifty-eight percent of respondents listed cost as a major hurdle. Numerous vendors have published cost analyses for single-use products, all of which we have found to be convincing. Maybe it’s time to get the word out again.

Much has been written and spoken about interoperability—or lack thereof—among single-use components. Could that be the reason 38% of respondents believed the ability to customize systems was lacking? Were they dissatisfied with customization options offered by vendors? Were they resentful of having to source everything from the same vendor, which is normally a plus?

Certainly, enough vendors these days supply complete, ready-to-go systems. Moreover, end users have never been fond of “rolling their own,” although just 22% believed that creating systems from components was a drawback.

Just slightly more than that (24%) selected leachables/extractables. One would think that with several industry groups tackling this problem, concern would be significantly higher.

GEN’s 2015 survey on single-use systems revealed some interesting information, but to a great degree reinforced what we have learned by speaking with thousands of industry experts over the years. We hope for even greater participation from readers, and greater granularity in the questions, in future surveys.

Merck Millipore’s PureFlex™ Plus film is used in the construction of Mobius® single-use process containers for biopharmaceutical manufacturing.

Please send any comments or questions to the attention of John Sterling, Editor in Chief, GEN, [email protected].

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