Bioprocessing Online recently discussed the biopharma single-use trend within bioprocessing. We have been seeing similar for quite a few years now. The transition from stainless steel and glass within bioprocessing and cell culture systems to sterilized single-use plastic storage bags and devices is paving the way for increased flexibility, lower operational costs and faster turnarounds.
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To maintain a competitive edge in biologics production, contract manufacturing organizations (CMOs) are continually searching for better, more innovative manufacturing strategies. According to our 16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production,1 the speed of single-use equipment adoption by CMOs is outpacing that of biopharma innovators for small- and mid-scale bioprocessing, and it is being used for larger-scale commercial manufacturing at an increasing rate. For example, CMOs are somewhat more likely to adopt single-use bioreactors than biodevelopers, at a rate of 87 percent vs. just under 80 percent. This allows them to stay competitive, especially for R&D and clinical trials, with better efficiency and at lower cost.
With the advancement of technology, knowledge, and experience in the single-use field, continued progress and market expansion across the biopharma sector (CMOs and innovators) are expected. Beyond that, adjacent sectors are seeing expansions and adaptations that have been implemented in mainstream biologics production. Among these, cell and gene therapy and the production of cosmetics and food derived from plant cell and tissue cultures are now occurring at manufacturing scales.
Compared to traditional equipment, single-use equipment, which is generally made of plastic parts sterilized by gamma irradiation, is used once and then discarded. Over more than a decade of combined industry experience, the benefits of single-use vs. fixed stainless steel have been demonstrated, including lower capital investment and operational costs and greater flexibility. With SUS, bioprocessing and progressive manufacture of multiple products at multiple scales in the same areas can be set up rapidly. Product lines have expanded from basic storage bags to complex bioreactors, so that almost all bioprocessing, particularly upstream, can be done with single-use systems.
Whereas only a few single-use systems, generally limited to 100 L, were available less than 20 years ago, single-use bioreactors and mixers are now available at ≤ 2,000 L scale. Systems above 2,000 L exist, but they are generally not practical or cost-effective due to engineering limitations. As more companies offer an increasing range of product options, 1,000 L bioreactors are on track to be become the industry standard for new product large-scale and much commercial-scale manufacturing.
Stainless-steel facilities still dominate, accounting for about 85 percent of the market, with single-use at about 15 percent. Over the next five to 10 years, the proportion is expected to shift to about 70 to 75 percent stainless and 25 to 30 percent single-use, including growth in the SUS market of up to 300 percent. These projections take into account that downstream applications will remain limited over the next five years, with some increased adoption of SUS continuous chromatography and increased use for commercial manufacturing. The numbers also reflect likely market growth from new players entering bioprocessing, including in developing countries and biosimilar developers.
It is anticipated that commercial-scale GMP manufacturing will show the most dramatic growth. The single-use market for commercial applications is projected to grow to over $1 billion/year in the next five years, driven by products using SUS that are currently in development receiving approval and graduating to commercial-scale manufacturing. New products will continue to mostly be monoclonal antibodies, which generally require manufacture of 100 kilograms or more. This will increasingly involve parallel tracks, continuous bioprocessing, and/or multiple facilities worldwide anchored by 500- to 2,000-L SUS bioreactors.
The most frequently used single-use products at any stage/scale are shown in Figure 1. Simpler devices, such as filter cartridges, bags, and tubing top the list. But it is significant that many facilities are adopting major bioprocessing systems, including nearly 80 percent using bioreactors, more than 70 percent using mixers, and nearly 70 percent using tangential flow filtration.
In search of a custom single-use plastic storage bag or component for use within a bioprocessing system or cell culture device? Let’s chat.