Single-use bioreactors are making good progress at the commercial scale, with 43.3% of biomanufacturers using them, versus 68.3% at the scale-up/clinical production stage. In this year’s 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, we examined the penetration of disposables across all stages of manufacture, as well as their application by stage.
As the industry and regulatory agencies gain more confidence and scientific information from utilization of these single-use systems, we expect their use in commercial applications to increase.
For the past six years, our study has asked global respondents from 31 countries which types of disposable and single-use systems they used at any stage in bioproduction (R&D through commercial production). Large jumps from 2006 occurred in the number of facilities using disposables (Table).
This year, though, we found a consistent slowing of the growth rate in adoption of single-use devices. This is to be expected. As more facilities use them, the rapid growth in adoption of single-use devices necessarily slows until a market equilibrium is reached. Our study shows that:
- Use of membrane adsorbers (at all scales of production) jumped from 12.9% (2006) to 50.6% (2011) of respondents reporting using disposables (a CAGR of 25.6%, down from 40% CAGR in 2009).
- Bioreactor usage (at all scales) grew from 21% in 2006 to 68.1% in 2011 (a CAGR of 21.7%).
- Mixing systems usage grew from 19.4% in 2006 to 54.8% in 2011.
- Preassembled tubing sets and rigging kits grew from 49.5% in 2007 to 69.9% in 2011.
Aside from possible market saturation, the slowing penetration of single-use disposables and adoption rates could be attributable to the poor economy. Other reasons for the leveling off of disposables adoption include mergers and fewer new companies. The decreasing number of new smaller emerging biopharmaceutical companies that typically adopt single-use disposable systems for clinical production has directly impacted penetration rates. Also, the recent spate of mergers and acquisitions has had an effect as smaller companies, which may be using single-use systems, are taken over.
Usage by Stage of Manufacturing
Disposables in 2011 continue to be used mainly during scaleup/clinical production and in process development. Among biotherapeutic developers and CMOs using disposables at the commercial manufacturing stage, the most commonly used (nonfilter) disposable products were buffer containers (50.7% at commercial-scale, and 75.4% in scaleup/clinical production).
Following were tubing for disposable applications used by 46.5% in commercial scale, and 72.4% in scaleup/clinical production. Sampling systems were used by 61% of respondents in their commercial-scale production.
The availability of nonfilter disposable systems has benefited many new biopharmaceutical startups and small to medium companies that are able to spend relatively less capital to quickly advance the development of new drugs through the proof-of-concept stage and beyond.
Nonfilter disposable systems that have made headway into commercial applications include:
- Media bags, purchased dry (59% of respondents reporting use)
- Tubing for disposable applications (47%)
- Buffer containers (51%)
- Bioreactors (43%)
- Sampling systems (61%)
- Media bags, wet (41%)
Our annual study data shows that disposable devices continue to make advances in manufacturing, and are becoming increasingly common in most areas of biopharmaceutical manufacturing. Although, as yet, there are few nonrigid single-use devices (e.g., storage bags) used in GMP applications, this is changing quickly as new products move through the development pipeline, into clinical-scale manufacturing, and on to regulatory approval for commercial GMP production.
Further, as regulators gain familiarity with the safety profiles and materials used in these devices, necessary approvals for product manufacture will be facilitated. When this occurs, the market volume for single-use devices is likely to increase significantly.
A basic problem that needs resolution is the demonstrated safety of the materials and plastics used for biopharmaceutical manufacture. These must be shown to be comparably as safe as using stainless steel-based bioprocessing. Indeed, the first company to document comparable “lack of known hazards” with bioprocessing equipment will have a window of opportunity within the commercial-scale manufacturing platform systems market.