When plastic pollution is known to be a significant global problem, it might seem paradoxical that single-use (plastic, disposable) biopharmaceutical technology use is on the rise. However, the improved efficiencies, flexibility, lower costs, reduced contamination risks and faster production times achieved with single-use technologies are driving the uptake of these apparatus, and it is widely argued that concerns over their environmental sustainability might not be as straightforward as they seem.
With increased adoption among startups and SMEs, as well as heavy investment from leading multinationals like Eli Lilly and Merck, the trend for single-use technologies is remarkable. Here, we look at some of the pros and cons of single-use equipment in biopharma, and we ask the question – could the future of biopharma be disposable?
What are single use technologies?
Single-use technologies have been commercially available for about 30 years, since companies like HyClone Laboratories (a cell culture media provider) pioneered sterile "bio bags” for media packaging in the late 1990s. However, the range and type of available disposable technologies has since expanded, now covering upscale bioprocessing to final formulation and filling. Single-use bags, connectors and tubing are commonly found within facilities that have adopted single-use technologies.
However, when most people refer to single-use technologies in biopharma, they are usually referring to single-use bioreactors. These apparatus saw relatively modest uptake until the COVID-19 pandemic. The subsequent and sudden high demand for vaccines is seen by many as the factor that drove the proportion of commercial-scale single-use bioreactors to grow from 32.5% in 2019 to 43% in 2022. However, even now, the uptake of disposable apparatus is continuing to grow, driven by increased global demand for biologics and vaccines. In fact, more than half of all commercial-scale bioreactors are now single-use.
Why the uptake?
Single-use bioreactors offer a speed and flexibility that stainless steel just can’t match. Facilities using them also have a much lower up-front capital investment and a shorter construction period as they reduce the time needed for building, cleaning and general maintenance. For example, if contamination occurs, downtime can be minimized as only the affected unit in a single-use set-up needs to be replaced, with limited loss of product or time. The same applies to any parts of a system that might need to be upgraded. As a result, one study suggests that after 10 years of active use, single-use bioreactors can reduce capital costs by 40–50%, time-to-build by 30%, and ongoing operating costs by 20–30% [1].
However, the global move towards single-use technologies is about more than just cost and process efficiencies. Over and above these advantages, it is argued that they are simply better suited to the demands placed on the modern biopharmaceutical company. In particular, single-use bioreactors are thought to support flexible manufacturing, while enabling efficient and rapid adjustment of production schedules and volumes.
For example, stainless steel bioreactors typically have volumes of 10,000 Liters or more, but this can actually lead to over-capacity, when a 2,000 Liter bioreactor can produce enough protein over a year to meet the needs of more than 50% of currently-marketed biologics. For on-demand production, personalized medicines for smaller patient groups, and for facilities simply needing to achieve flexibility in order to manage capacity utilization, the traditional stainless-steel set-up is no longer always the best solution. This is a main driver for biopharma companies to switch to smaller, more flexible single-use bioreactors.
Conversely, for situations requiring very large volumes (single-use bioreactors tend to be limited by pressure challenges to around 6,000 Liters), scaling out, which involves using multiple bioreactors parallel, can be implemented flexibly to increase production capacity. For example, a recent article in Contract Pharma [2] explained that WuXi Biologics’ facility in Ireland houses four 4,000L SUBs, enabling the company to ‘scale out’ its biomanufacturing at 4,000L, 8,000L, 12,000L and 16,000L, for different...
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