Single-use Technology: An Emerging Technology

Single-Use Downstream Bioprocessing Technology Market: With the increasing global population, the incidence rates of several chronic disease indications, are on the rise. This has led to a rise in the demand for effective treatment options for patients suffering from these diseases. In order to improve the quality of life for these patients, several companies emerged for the development of best possible treatment options. One such option is novel biologics / therapies.

For which, companies require efficient, high yielding, sterile bioprocessing systems. As a result of which, innovators came up with the idea of single-use upstream and downstream technologies.  These technologies has the potential to overcome various challenges associated with the stainless-steel equipment.

The development of single-use downstream equipment started nearly 40 years ago in 1980s with the manufacturing of small process-scale plastic filter capsules replacing stainless-filter housing assemblies. In addition to being user-friendly and convenient for biopharmaceutical manufacturers, single-use technology offer cost saving potential, which in return assists in lowering the cost of manufactured biologics. Further, it lowered costs associated with its facility installation by minimizing the contamination risk to a great extent.,

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Single-use Technology For Efficient  Bioprocessing

The increased acceptance and approval of various biologics is a positive sign that novel cures and treatment options for a variety of ailments and diseases afflicting today's global population are on the way.

As a result of the effectiveness of these initiatives, stakeholders have decided to modernize the traditional biologics manufacturing technologies. Given the inherent benefits of single-use downstream equipment, a number of players have launched their proprietary products for use at different scale and mode of operation. The demand for more productivity and flexibility, greater profitability, and faster time to market are some of the factors pushing the replacement of traditional stainless steel equipment with single-use technology as the biopharmaceutical industry evolve.

These technologies have become widely utilized in the bioprocessing sector for R&D and clinical production in recent years, particularly for upstream bioproduction, followed by downstream bioprocessing attempting to keep up with the rising single-use upstream production and utilization.

Because of multiple advantages and benefits over traditional stainless steel technologies, such as reduced CO2 emission, lower project lead time, reduction in total labor and risk associated with cross contamination, single-use technologies have increasingly become an essential tool in the development of various biotechnological processes.

Equipment launched by several developers in the field of single-use downstream bioprocessing includes disposable chromatography systems, disposable filtration systems, disposable sampling systems, disposable connectors and disposable centrifugation systems. Apart from providing scalable downstream bioprocessing equipment, few developers have incorporated automation, resulting in a user-friendly device.

Further, it is worth mentioning that several developers have made significant efforts in developing novel single-use downstream bioprocessing equipment, paving the way for new generation of downstream bioprocessing devices. The field is presently witnessing several innovations, such as visual data display, remote accessibility, data processing capability, Built-in System Control Sensors, Irradiation (Gamma or x-ray), Provision for Alarms / Alerts and input / output compatibility. In this context, it is worth highlighting that nearly 440 patents have been filed / granted, since 2001, for single-use downstream bioprocessing technologies and equipment..   

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Future of Single-use Downstream Bioprocessing Equipment

Driven by encouraging patent filing efforts, new pharma entrants, broadening of disease focus, and a rising desire to get beyond existing stainless-steel equipment with some innovative ways that could decrease prices and address risk of cross contamination along with high productivity, the single-use equipment are expected to capture a significant share in the biopharmaceutical market with more developers developing productive disposable downstream equipment over the coming decade.

Concluding Remarks

Device developers are actively making efforts to introduce several technical and qualitative features in single-use downstream devices to make them efficient for use, contamination free and disposal. In almost all these equipment, such as single-use chromatography systems, filtration systems, sampling systems, centrifugation systems and connectors, the developers have taken care of sterility. Autoclaving and irradiation (gamma or x-ray) features are must for such equipment, manufacturing life-saving biologics.

The industry is constantly evolving in the space of single-use technology with emergence of more convenient and scalable systems. As the number of commercially available biologics increase, the need for novel manufacturing equipment is also expected to elevate.

The historical trends of the existing single-use upstream bioprocessing equipment, such as single-use bioreactors, suggest a strong demand in the market. The single-use downstream bioprocessing equipment market is expected to follow a similar growth trend as more developers shift from conventional to user-friendly, high quality, scalable, disposable biopharmaceutical manufacturing alternatives.

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