Single-use chromatography is a relatively new separation technology that hails from the bioprocessing industry. Single-use products, such as disposable filter capsules and single-use bioreactors, were initially applied to the upstream sector of bioprocessing to reduce cleaning time and minimize contamination. As the downstream sector also requires a sterile separation process, single-use applications also expanded towards the downstream process. Recent advancements in technology and material science have made disposable chromatography systems possible at a reasonable cost.

Traditional chromatography columns, which utilize ion exchange/affinity resins, are now being replaced by disposable membrane adsorber columns. Single-use membrane adsorbers, also known as membrane chromatography, can be thought of as a hybrid of filtration membranes and chromatography resins. Chromatography resins are limited by diffusion and flow rates through their pores, creating a significant bottleneck for high productivity in bioprocessing. Membrane filtration provides much faster flow-through rates. Membrane adsorbers combine elements of both, by coating membranes with surface-functionalized groups used in resin chromatography. With higher flow rates, single-use chromatography is able to decrease processing time and increase throughput. Along with the elimination of cleaning processes, these advantages of the disposable column will lower operating costs while significantly improving separation yield.

As demand for single-use columns is rising, there is also an increasing interest towards a specialized system for single-use chromatography. Dedicated single-use chromatography

 

ÄKTAready from GE

systems became available between 2007 and 2008 with GE Healthcare’s ÄKTAready system, which is optimized to use single-use chromatography columns. In principle, there are other systems that can be configured for single-use column and/or membrane chromatography applications. However, they are not generally configured this way, but instead, are more often used for a variety of filtration applications or buffer preparations. In a dedicated single-use system, usually the instrument will have a disposable flow path or other single-use hardware components such as sensors and vessels. These systems are designed to integrate automated chromatography processes into single-use assemblies, which further reduce cleaning time and increase product yield in a hygienic process.

Despite all of these advantages, single-use chromatography still has some limitations, especially in terms of scalability. This technology was initially developed for early product development, which then evolved into a production stage in bioprocessing. While single-use chromatography is thriving in bioprocessing, which generally has moderate production volume, there are still scale limitations for very large-scale production in other industries such as chemicals and pharmaceuticals. Therefore, further advancements are still under development in order to apply this technology to mass manufacture. One potential solution is to incorporate this technology into continuous chromatography systems, such as simulated moving bed (SMB). SMB is capable of separating a massive volume of products through continuous processing of smaller batches.

For now, demand for single-use chromatography is rising, driven by the need to provide sterile, contaminant-free environments, which is of particular importance in the production of vaccines and biologics-based therapeutics. Single-use chromatography has developed into a sizable market in less than a decade due to its advantages in the biopharmaceutical industry, such as avoiding cleaning validation and reducing variability in stationary phase media packing. This fast-growing market is the one to watch for industry participants, instrument manufacturers, and other related observers.

A detailed analysis of this market can be found in SDi’s newest report:  Purification & Filtration Markets: Seeking Clarity. This report evaluates the global purification and filtration market along with every technique involved within it. The market covers ten different purification and filtration technologies. An analysis of end-user perspectives based on a survey of 145 respondents across various industries and regions is also included in this study. The market analysis and survey will provide insight for participating vendors looking to innovate and implement business strategies based on current market conditions and what the customer actually wants.

Below is an overview of the purification and filtration market:

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