The disposable bioprocessing market, which began with plastic bags designed for buffer preparation and quickly evolved to disposable bioreactor bags on rocking platforms, has blossomed into a range of products for cell culture and the processes upstream and downstream of the bioreactor itself.
In fact, there is a growing perception that a completely disposable bioprocess stream is feasible and even within reach. The biggest hurdles remaining relate to disposable technology development in the areas of biosensors and chromatographic purification. Progress is being made in these areas, though, and the buzz at recent scientific meetings has shifted from the challenges to an emphasis on the opportunities disposable products provide, especially in terms of ease of use, flexibility, maximizing infrastructure utilization, and, perhaps most notably, cost savings and environmental impact.
A key advantage of disposable components is the ability to build flexible manufacturing schemes that can readily be transitioned between products and projects. This is an especially important advantage for contract manufacturers (CMOs), which can maintain versatile production facilities without the need for extensive cleaning and cleaning validation protocols, and with greatly reduced risk of cross-contamination between product streams. Flexible manufacturing that enables rapid scale-up is particularly critical in areas such as vaccine production.
Disposables can greatly reduce the overall regulatory burden, the demand for energy and water to produce steam for steam-in-place operations, and the need for harsh cleaning chemicals and their removal during clean-in-place functions. These factors are not only economic drivers, they also represent sound environmental reasons for the use of disposables.
How close the bioprocessing industry is to a fully disposable process stream depends, in part, on scale. For small clinical batches, highly bioactive compounds, or personalized medicines, such as patient-specific vaccines, production can be done in disposable systems from start to finish. Large-scale manufacturing—for example, production of monoclonal antibodies in 10,000–20,000 liter stainless steel tanks—cannot be done economically with today’s disposable technology. For working volumes between these small-scale and large-scale applications, hybrid systems are pieced together, combining conventional and disposable elements.
The first reaction is often that an increase in solid waste associated with a disposable flow path is antigreen; yet, notes Jerry Martin, svp, scientific affairs at Pall Life Sciences, the significant reductions in energy use, purified water use, and toxic cleaning chemicals realized with a switch to disposable process streams, results in “an environmental positive.”
Although the growing consensus is that disposables are ultimately both green and economical, there remains the issue of solid-waste production, as most of the single-use products employed in biomanufacturing are not recyclable given the technology available at present. Whether disposal in a landfill or incineration is the better option is open to debate, says Martin, who describes efforts under way to develop methods for burning plastics as a cogeneration source for energy production.
A substantial effort is being devoted to assessing the potential economic and environmental gains to be realized by implementing disposable technology. Nigel Darby, GM of biotechnologies at GE Healthcare, says that, although it is “too early to predict the outcomes of these studies, early data suggest that environmental impact will not be rate-limiting in the adoption of this technology and may even provide a net environmental benefit.” Furthermore, “disposables tend to decrease the amount of capital investment,” providing an economic incentive. Although a company will spend more on consumables with a disposable process stream, it appears that the overall result is a cost saving.