Shifting applications of disposables changes what’s critical to future use.

Equipment-specific implementation problems and materials issues are the top roadblocks to greater adoption of disposable applications, according to preliminary results from BioPlan Associates’ latest annual study, 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. The data suggests that over the past 10 years, the industry has moved well beyond decisions regarding whether disposables can be implemented, to decisions regarding the potential impact of problems associated with implementation.

We asked qualified industry respondents to indicate the most important reason they might not increase their use of single-use disposable technologies. Among the 23 factors cited, this year, the two most-frequently indicated constraints are:

• Breakage of bags and loss of production material (12.5 percent of respondents)
• Leachables and extractables concerns (also 12.5 percent)

These concerns are consistent with responses from last year, where breakage of bags was the top factor hindering further adoption of single-use technologies.¹ Concerns over leachables and extractables topped the list in the 3 years prior to that. In fact, L&E-related issues pop up elsewhere among roadblocks, with the lack of clear regulatory guidance in this area also among the top 10 constraints to further adoption.

To quantify the extent to which L&E concerns figure into the equation, data from last year’s study indicates that biomanufacturers would pay an average markup of 13.4 percent to suppliers if the supplier provided “usable” leachables and extractables data. In fact, last year fewer than one-third of respondents reported satisfaction with their vendor for its provision of L&E data that regulators would accept, even as this was one of the most important single-use product attributes (cited as important by more almost 87 percent of respondents).

Shifts in Problems from Last Year

One of the biggest changes we’re witnessing in this year’s preliminary results relates to regulatory reasons. Last year, the inability to change current systems due to regulatory reasons was the second-most cited critical reason for not increasing use of disposables, cited by 15.2 percent share of respondents. That had represented a spike for this particular hindrance in comparison to years past. This year, results to-date indicate that the biomanufacturing community’s worries have eased considerably, with this receding to almost a non-factor, cited by only 2.3 percent of respondents.

Breakage of bags and loss of production materials also appears to be easing in the community’s minds, although it remains the joint top hindrance in this year’s results to-date.

In their stead, a growing share of respondents are reporting other concerns, including:

• The high cost of consumables (11.4 percent this year, versus 8.1 percent last year)
• Limited scalability over a broad range, such as 2L-2,000L (10.2 percent vs. 7.1 percent)
• Not wanting to become vendor-dependent (10.2 percent vs. 6.1 percent)
• A lack of disposable equipment that meets process requirements (9.1 percent vs. 4 percent)

Cost is a Rising Concern

The high cost of consumables appears to have rebounded as a concern in recent years. The 11.4 percent of respondents citing this as their top barrier this year represents almost double the share of respondents (6.3-6.7 percent) who saw this as their biggest hindrance from 2012 to 2014.

This may have to do with the industry’s focus on implementation of these devices. According to preliminary results from this year’s study, some 11 percent share of respondents name single-use system implementation and integration as their most important trend of the year, compared to 5.9 percent who point to better single-use devices as the most important trend on which the industry should focus its efforts.

As some disposable applications begin to reach market saturation—at least in early stage manufacturing—the industry may be factoring in ongoing single-use running costs that were not as apparent during earlier stages of adoption. For example, while single-use equipment is lauded for its ability to reduce capital investments in facility and equipment, there are recurring expenses and operational costs tied to the purchase of new disposable applications and devices for each manufacturing run/batch.

Satisfaction with Suppliers

Satisfaction with vendors on the cost of these products also runs very low. Last year’s results indicate that just one-fifth (21.6 percent) of respondents were very satisfied or satisfied with their single-use vendors’ product costs. That was the second-lowest satisfaction rate of the 13 attributes we measured. Additionally, in comparing the importance of these attributes with respondents’ satisfaction rates, we found that the biggest gap was for product cost. Not too surprisingly, the second-biggest gap was the provision of L&E data that regulators would accept.

Despite Concerns, Single-Use Adoption Continues

While equipment-specific worries, concerns over L&E, and cost issues have the potential to slow the adoption of disposable applications, our survey data shows that these are not having too great of an effect at this time.

Consider that our preliminary results indicate that for clinical scale manufacturing, respondents would be more likely to implement a single-use bioreactor than a stainless steel one for a hypothetical clinical-scale biologics facility 2 years from now. Likewise, there are indications that a sizable share would specify a single-use bioreactor in 2 years’ time for a commercial-scale manufacturing facility, also.

Meanwhile, although the focus might be on implementation rather than innovation, single-use devices continue to be amidst the top areas on which the industry wants suppliers to focus their development efforts.

As such, our study demonstrates that while there are real concerns with single-use devices that could be slowing adoption, these do not appear to have factored too heavily into the industry’s collective mind so far.

Reference

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

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. elanger@bioplanassociates.com; 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 28 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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