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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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