Single-use bioprocessing (SUB) is revolutionizing the field of biopharmaceutical manufacturing globally. SUB refers to the usage of vessels, equipment, conduits, and other active consumables that come into contact with process fluids only once and are then discarded after the usage. In their purest form, SUB replaces stainless steel or glass with plastic products. The components used in SUB manufacturing are polyamide, polycarbonate, polyethersulfone, polyethylene, polypropylene, polyvinyl chloride polytetrafluoroethylene, cellulose acetate, and ethylene vinyl acetate.

The global SUB market is projected to generate revenues of approximately $7 billion by 2024, with CAGR of more than 14% during 2018-2024

Why companies prefer SUB?

Several biopharma companies are adopting this technology for its ease and flexibility. This technology offers customization depending on the varying product supply and demand. Also, it has many key advantages such as low-capital expenditure, reduced risk of cross-contamination, and flexibility to meet changing consumer needs.

The global SUB market is categorized into the following segments based on application:

  • Filtration

The filtration segment accounts for a major share of 34% in the overall global SUB market. Single-use filtration solutions benefit biopharmaceutical manufacturers by saving on energy costs, reduced contamination, cleaning expenses, and time. Single-use filtration devices in global SUB market feature high-efficiency membrane components that allow high-temperature metabolic reactions to flow smoothly. Due to the benefits, they are widely used in research activities and across small and large-scale production batches.

In April 2017, Merck KGaA introduced Pellicon Capsule with Ultracel membrane, a first-of-its-kind single-use tangential flow filtration capsule for bioprocessing of monoclonal antibodies and antibody-drug conjugates, thereby boosting growth of the in the global SUB market.

  • Storage & Transfer

The storage and transfer segment accounts around of 1/3rd of the total global SUB market share. Single-use storage solutions are critical as the manufacturing of biopharmaceuticals involves handling large volumes of liquids such as media and buffer during upstream, downstream, formulation, and filling bioprocesses. The major advantages of single-use storage and transfer products include – scalability, ready integration, operational, and economic & cost-effective.

For example, in the global SUB market, LabPure fluorinated ethylene propylene bags from Saint-Gobain are manufactured with a proprietary laser-sealed method that ensures safe storage of liquid and process materials.

  • Cell Culture

The cell culture segment accounts for less than 1/4th of the total global SUB market share. Cell culture operations plays a vital role in determining overall bioprocess productivity. Single-use bioreactors are used for cell culture applications during bioprocessing. The numerous advantages of cell culture such as the elimination of validation issues lowered risk of cross-contamination, shortened downtime,  and turnaround time due to the usage of new bags for each run is leading to an increase in the adoption of single-use cell culture systems by biopharmaceutical companies in the global market.

For example, in the global SUB market, GE Healthcare offers Xcellerex XDR 50 to 2000L single-use stirred-tank bioreactors for various cell culture applications.

  • Mixing

The mixing segment accounts for less than ⅓ of the total global SUB market share. Mixing is a critical procedure for applications ranging from media and buffer preparation and in-process unit operations such as low pH viral inactivation to the final formulation. There are several advantages such as – reduced sterilization and cleaning demands, potential cost savings, ease-of-use, minimal requirement of pharmaceutical qualification and validation procedures, and the reduced risk of cross-contamination.

For instance, in the global SUB market, Thermo Fisher Scientific offers latest and innovative mixing platforms that address the needs of proper preparation of buffers, media, and other process liquids with mixing capacity ranging from 30 L to 5,000 L.

  • Purification

The purification segment accounts for the smallest total global SUB market share. Single-use sensors in first-generation single-use purification systems such as membrane absorbers and chromatography columns do not have great sensitivity and accuracy to analyze the quality and purity of biologic drugs.

For example, in the global SUB market GE Healthcare is offering ready-to-use chromatography columns with inner diameters of up to 450mm for disposable purification processes from bioreactors up to 2000 L volume.

Read:Single-use Bioprocessing Market - Global Outlook and Forecast 2019-2024

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